Worldwide Distribution - US (Nationwide) and in the countries of  Canada, Puerto Rico, United Arab Emirates, Philippines, and  Europe.
AirLife Resuscitation, Infant, with mask, 28inch large bore tubing, pressure-relief valve    Product Usage:  The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.
The mask component on various lots of the resuscitation devices have been identified as having the  potential to exhibit a sticking condition which may result in a difficult to/unable to disconnect condition of the  mask from the elbow of the resuscitator.
AirLife Resuscitation, Infant, with mask, oxygen reservoir bag, pressure-relief valve, PEEP valve    Product Usage:  The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.
AirLife Resuscitation, Infant, with mask, 40inch oxygen reservoir tubing, pressure-relief valve, PEEP valve    Product Usage:  The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.
AirLife Resuscitation, Adult, with mask, oxygen reservoir bag, CO2 detector    Product Usage:  The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.
AirLife Resuscitation, Pediatric, with mask, 40inch oxygen reservoir tubing, pressure-relief valve, Broselow    Product Usage:  The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.
AirLife Resuscitation, Infant, with mask, oxygen reservoir bag, pressure-relief valve    Product Usage:  The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.
AirLife Resuscitation, Infant, with mask, 40inch oxygen reservoir tubing, pressure-relief valve, Broselow    Product Usage:  The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.
AirLife Resuscitation, Pediatric, with mask, oxygen reservoir bag, pressure-relief valve    Product Usage:  The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.
AirLife Resuscitation, Pediatric, with mask, 40inch oxygen reservoir tubing, pressure-relief valve, filter    Product Usage:  The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.
AirLife Resuscitation, Broselow Hinkle Kit    Product Usage:  The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.
AirLife Resuscitation, Adult, with mask, oxygen reservoir bag, CO2 detector, PEEP valve    Product Usage:  The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.
AirLife Resuscitation, Pediatric, with mask, 40inch oxygen reservoir tubing, pressure-relief valve    Product Usage:  The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.
AirLife Resuscitation, Pediatric, with mask, 40inch oxygen reservoir tubing, pressure-relief valve, CO2 monitor    Product Usage:  The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.
AirLife Resuscitation, Pediatric, with mask, oxygen reservoir bag, pressure-relief valve, PEEP valve    Product Usage:  The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.
AirLife Resuscitation, Adult, with mask, oxygen reservoir bag, CO2 detector, manometer    Product Usage:  The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.
AirLife Resuscitation, Adult, with mask, oxygen reservoir bag, PEEP valve    Product Usage:  The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.
AirLife Resuscitation, Infant, with mask, 40 inch oxygen reservoir tubing, pressure-relief valve, CO2 detector, manometer    Product Usage:  The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.
AirLife Resuscitation, Adult, with mask, 28inch large bore tubing    Product Usage:  The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.
AirLife Resuscitation, Adult, with mask, oxygen reservoir bag, manometer, PEEP valve    Product Usage:  The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.
AirLife Resuscitation, Adult, with mask, 28inch large bore tubing, pressure-relief valve    Product Usage:  The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.
AirLife Resuscitation, Replacement kit for outer shell, Broselow    Product Usage:  The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.
AirLife Resuscitation, Pediatric, with mask, 28inch large bore tubing, pressure-relief valve    Product Usage:  The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.
AirLife Resuscitation, Infant, with mask, 40inch oxygen reservoir tubing, pressure-relief valve, manometer    Product Usage:  The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.
AirLife Resuscitation, Adult, with mask, oxygen reservoir bag, manometer    Product Usage:  The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.
AirLife Resuscitation, Adult, with mask, 40inch oxygen reservoir tubing, PEEP valve    Product Usage:  The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.
AirLife Resuscitation, Infant, with mask, 40inch oxygen reservoir tubing, pressure-relief valve, CO2 monitor, monometer    Product Usage:  The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.
AirLife Resuscitation, Adult, with mask, oxygen reservoir bag, filter    Product Usage:  The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.
oxygen reservoir tubing 6/cs    Product Usage:  The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.
AirLife Resuscitation, Pediatric, with mask, 40inch oxygen reservoir tubing, pressure-relief valve, CO2 monitor, monometer    Product Usage:  The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.
AirLife Resuscitation, Infant, with mask, 40inch oxygen reservoir tubing, pressure-relief valve, manometer, PEEP valve      Product Usage:  The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.
AirLife Resuscitation, Pediatric, with mask, oxygen reservoir bag, manometer, pressure-relief valve, PEEP valve    Product Usage:  The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.
AirLife Resuscitation, Pediatric, with mask, 40inch oxygen reservoir tubing, pressure-relief valve, PEEP valve    Product Usage:  The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.
AirLife Resuscitation, Adult, with mask, 40inch oxygen reservoir tubing, filter    Product Usage:  The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.
AirLife Resuscitation, Adult, with mask, oxygen reservoir bag    Product Usage:  The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.
Dimension Vista Glucose (GLU) assay; (Product Number: K1039/10445162) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid may interfere with the drugs sulfasalazine and/or sulfapyridine causing falsely elevated or falsely depressed results.
Dimension Vista Creatine Kinase MB (MBI) assay; (Product Number: K3032/10464339) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
Dimension Vista Aspartate Aminotransferase (AST) assay; (Product Number: K2014/10445148) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
Dimension Glucose (GLUC) assay (Product Number: DF40/10444973) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
Dimension Vista Ammonia (AMM) assay (Product Number: K3119/10711992) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
Syva Emit 2000 Tacrolimus Assay (Product Number: 8R019UL/10445397) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
Dimension Vista Thyroxine (T4) assay; (Product Number: K6065/10445101) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
Dimension Ammonia (AMM) assay; (Product Number: DF119/10711991) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
Dimension Alanine Aminotransferase (ALTI) assay; (Product Number: DF143/10475530) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
Dimension Aspartate Aminotransferase (AST) assay (Product Number: DF41A/10444959) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
Dimension Vista Alanine Aminotransferase (ALTI) assay; (Product Number: K2143/10635565) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
ADVIA Ammonia (AMM) chemistry assay, an in vitro diagnostic device intended to quantitatively measure Ammonia levels in human plasma (heparin or EDTA). Product Number: 10286035 (Mfr: Randox Laboratories)
ADVIA  Salicylate (SAL) reagent chemistry assay; use in the quantitative determination of salicylate in human serum and plasma (lithium heparin). Product Number: 10327382 (Mfr: Sekisui Diagnostics)
Syva Emit 2000 Sirolimus Assay (Product Number: 8S019UL/10445401) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
Dimension Thyroxine (T4) assay (Product Number: DF65/10444908) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
Dimension Creatine Kinase MB (MBI) assay (Product Number: DF32/10464510) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
ADVIA Alanine Aminotransferase (ALT) reagent chemistry assays; ALT intended to measure the activity of the enzyme alanine amino transferase (ALT) (also known as a serum glutamic pyruvic transaminase or SGPT) in serum and plasma.  (Product Numbers: 10318168, 10309500), ALT P5P (Part Numbers: 10318168/10326245, 10309500/10315181), and ALT Concentrated (Part Numbers: 10283341, 10283341, 10283342); (Mfr: Randox Laboratories)
PerkinElmer Life and Analytical Sciences, Wallac, OY
Distributed in 20 US states: AL, AR, AZ, CA, CO, FL, GA, IL, IN, KS, KY, LA, MI, MO, NV, OH, OR, SC, TN, TX.
There is a potential for leaking vials for certain lot numbers where, if proper attire is not used as instructed, a transient minor allergic skin reaction may result when handling leaking succinylacetone reagent vials.
Distributed in the following U.S. states: FL, MA, MI, OH, OK TN, and Netherlands.
ReNew Dolphin Nose Disposable Dissector Tip, Catalog Number: 3312, UDI: 00811099011989    The ReNew single patient use disposable tips are to be used with the ReNew Laparoscopic Hand Pieces and they are indicated for cutting, grasping, dissecting and coagulation of tissue in endoscopic and laparoscopic surgical procedures.
Certain lots of disposable laparoscopic instrument tips may potentially have a compromised sterile barrier.
ReNew Endocut Scissor Disposable Tip, Catalog Number: 3142, UDI: 00811099012115    The ReNew single patient use disposable tips are to be used with the ReNew Laparoscopic Hand Pieces and they are indicated for cutting, grasping, dissecting and coagulation of tissue in endoscopic and laparoscopic surgical procedures.
Calibration failure - confirmed a positive bias with LIPL lot FB8109 when compared to other Dimension LIPL lots. Lot FB8109 is not meeting Siemens internal specifications for lot-to-lot limits.
Worldwide Distribution in the states of  AL, AZ, CA, CO, CT, FL, GA, IL, IN, KS, KY, LA, MA, MN, MO, MS, NC, NJ, NY, OH, OK, PA, PR, SC, SD, TN, TX, UT, VT, WA, WY.      Distributed internationally to Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Bangladesh, Barbados, Belarus, Belgium, Bosnia and Herzegovi, Botswana, Brazil, Brunei, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Egypt, Finland, France, Gaza and Jericho, Georgia, Germany, Greece, Guatemala, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Jamaica, Jordan, Kazakhstan, Kenya, Kuwait, Kyrgyzstan, Latvia, Lebanon, Lithuania, Luxembourg, Malaysia, Maldives, Mexico, Morocco, Netherlands, Nigeria, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Republic of Yemen, Romania, Russia, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Switzerland, Taiwan, Tajikistan, Thailand, Tunisia, Turkey, Uganda, United Arab Emirates, Uganda, United Kingdom, Uruguay  .
ARCHITECT DHEA-S Reagent    Product Usage:  It is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of dehydroepiandrosterone sulfate (DHEA-S) in human serum and plasma on the ARCHITECT iSystem.
Falsely elevated results may be obtained when using the ARCHITECT DHEA-S assay with samples from infants up to 60 days old.
Nationwide and Canada, Mexico, and Thailand
Concentrations for the level of biotin that does not interfere is not currently listed in the instruction for use for the Dimension Vista CTNI, Dimension Vista MMB, Dimension Sirolimus, ADVIA Centaur FOL, ADVIA Centaur aHBcM and the following IMMULITE assays, 3gAllergy  Specific IgE, anti-HBc, BR-MA (CA15-3), CEA, Folic Acid, Gastrin, OM-MA (CA125), Thyroglobulin, and Vitamin B12, and these assays are susceptible to interference from biotin.
SIRO, sirolimus test system,  DF306, SMN# 10464331    Lot codes:  BB7336  FA8037  FA8081  BB8167  FB8177  FB8219
Concentrations for the level of biotin that does not interfere is not currently listed in the instruction for use for the Dimension Vista CTNI, Dimension Vista MMB, Dimension Sirolimus, ADVIA Centaur FOL, ADVIA Centaur aHBcM and the following IMMULITE assays, 3gAllergy Specific IgE, anti-HBc, BR-MA (CA15-3), CEA, Folic Acid, Gastrin, OM-MA (CA125), Thyroglobulin, and Vitamin B12, and these assays are susceptible to interference from biotin.
OM-MA (CA125), OM-MA (CA125) (IMMULITE/IMMULITE 1000, LKOP1), (IMMULITE 2000/IMMULITE 2000 XPi, LKOP2)    Lot codes:  CA125 (OM-MA)  0211  0212  0213
OM-MA (CA125), OM-MA (CA125) (IMMULITE/IMMULITE 1000, LKOP1), (IMMULITE 2000/IMMULITE 2000 XPi, LKOP2)    Lot codes:  CA125 (OM-MA)  287  289  290
CEA, CEA (IMMULITE/IMMULITE 1000, LKCE1), (IMMULITE 2000/IMMULITE 2000 XPi, LKCE2, LKCE6)    Lot codes:  0355  0356  0357
The concentrations for biotin listed in the non-interfering substances section of the instructions for use for the Dimension TSHL, Dimension LOCI FT4L, Dimension Vista TSH, ADVIA Centaur Cyclosporine, and ADVIA Centaur DHEAS, incorrectly state the level at which biotin does not interfere.
TSHL, radioimmunoassay, thyroid-stimulating hormone, RF612, SMN# 10464524    Lot codes:  EB7276  EC7298  EA7318  EB7346  EC7346  EA8012  EA8033  EA8051  EC8080  EB8107  EB8121  EA8143  EB8143  EA8177  EB8177  EB8199  EA8223  EA8241  EA8261
CEA, CEA (IMMULITE/IMMULITE 1000, LKCE1), (IMMULITE 2000/IMMULITE 2000 XPi, LKCE2, LKCE6)    Lot codes:  0355  0356  0357    CEA Lot #  200 tests  311  312  313
MMB, colorimetric method, cpk or isozymes, K6420, SMN# 10445097    Lot codes:  16284BD  16312BB  17011BD  17058BD  17093BC  17136BE  17186BE  17235BC  17268BA
BR-MA/CA15-3, BR-MA/CA15-3 (IMMULITE/IMMULITE 1000, LKBR1), (IMMULITE 2000/IMMULITE 2000 XPi, LKBR2)    CA15-3(BR-MA) Lot #  265  266  267
The concentrations for biotin listed in the non-interfering substances section of the instructions for use for the Dimension TSHL, Dimension LOCI FT4L, Dimension Vista TSH, ADVIA Centaur Cyclosporine, and ADVIA Centaur DHEAS, incorrectly state the level at which biotin does not interfere
TSH, radioimmunoassay, thyroid stimulating hormone, RF612, SMN# 10464524    Lot codes:  16277BD  16322BB  17005BB  17023AC  17069AA  17093BB  17122AA  17150AA  17193BA  17215AC  17268AA
Vitamin B12, Vitamin B12 (IMMULITE/IMMULITE 1000, LKVB1)    Lot codes:  0338  0339  0340  0341
BR-MA/CA15-3, BR-MA/CA15-3 (IMMULITE/IMMULITE 1000, LKBR1), (IMMULITE 2000/IMMULITE 2000 XPi, LKBR2)    Lot codes:  0312  0313
Gastrin, Gastrin (IMMULITE/IMMULITE 1000, LKGA1), (IMMULITE 2000/IMMULITE 2000 XPi, LKGA2)    Lot codes:  Gastrin Lot #  0345  0346  0347
Folic Acid, Folic Acid (IMMULITE 2000/IMMULITE 2000 XPi L2KFO2, L2KFO6)    Lot codes:  Folic Acid Lot #  502  503  504  505  506  508  514
TG, TG (IMMULITE/IMMULITE 1000, LKTY1(D)), (IMMULITE 2000/IMMULITE 2000 XPi, LKTY2(D))    Lot codes:  0289  0290  0291  D0289  D0290  D0291
Gastrin, Gastrin (IMMULITE/IMMULITE 1000, LKGA1), (IMMULITE 2000/IMMULITE 2000 XPi, LKGA2)    Lot codes:  251  252  253  254  255
Anti HBc, Anti HBc (IMMULITE 2000/IMMULITE 2000 XPi L2KHC2 (D))    Lot codes:  Anti HBcM #  579  580  581  D579  D580  D581
3g Allergy specific IgE Universal kit, 3g Allergy specific IgE Universal kit (IMMULITE 2000/IMMULITE 2000 XPi L2KUN6 (D))    Lot codes:  3g Allergy Specific IgE Lot #  461  462  463  464  465  466  467  468  469  470  471  472  473  475  476  3g Allergy Specific IgE Lot #  D463  D464  D465  D466  D467  D469  D471  D472  D476  D483
DePuy Mitek, Inc., a Johnson & Johnson Co.
US Nationwide Distribution in the states of OH, WA, CO
LATARJET EXPERIENCE Sharp Curved Ostetome    Product Usage:  The Latarjet EXPERIENCE Instability Shoulder Set is intended to provide to the orthopedic surgeon with a means of bone fixation and to assist in the management of reconstructive surgeries.
Reports of product loosening or coming unscrewed from the handle.
Distribution was made to medical facilities in AZ, CA, CT, FL, IL, IN, KS, KY, MI, MN, MO, NJ, NY, NC, OH, PA, TX, VA, and WA.  There was no military/government distribution.    Foreign distribution was made to Argentina, Australia, Austria, Belgium, Bosnia Herzeg, Colombia, Croatia, Denmark, France, Germany, India, Ireland, Israel, Italy, Japan, Mexico, New Zealand, Philippines, Poland, Republic Korea, Romania, Singapore, Slovakia, Spain, Sweden, Taiwan, Thailand, Turkey, UAE, and Vietnam.
ACUSON SC2000 Ultrasound System.  The firm name on the label is Siemens Medical Solutions USA, Inc., Buffalo Grove, IL.
The ECG signal may flatline due to electromagnetic interference during the use of electrosurgical equipment.
Software versions VB20A, VB20B, or VB20C that have a common physio module (CPM) (known by customers as the ECG (physio) hardware) installed at revision 4
Worldwide Distribution - US Nationwide and the countries of Brazil, Canada, Malaysia, Singapore, Taiwan, Thailand, Turkey
BECKMAN COULTER iChemVELOCITY, Urine Chemistry System, Catalog Numbers:  800-3530, 800-7167, 800-7719, 800-7720, 800-  7106, 800-3049, 800-3050, 800-3079, 800-3080,  800-7190, 800-7713, 800-7714, 800-7715, 700-  7176-001, 700-7177-001    Product Usage:  The iChemVELOCITY automated urine chemistry system is an in vitro diagnostic device used to automate the urine chemistry analysis profile using iChemVELOCITY Urine Chemistry Strips. The iChemVELOCITY can be used as a stand-alone system, as well as in an iQ200 Series system, a configuration given the proprietary name iRICELL as it is designed to be hardware and software compatible with iQ200 Series systems. It produces quantitative results for specific gravity, semi- quantitative results for glucose, blood, leukocyte esterade, bilirubin, urobilinogen, pH, protein, ketones, and ascorbic acid; and qualitative results for nitrites, color, and clarity. iChemVELOCITY strips are intended for use only with the iChemVELOCITY analyzer. In particular they are not intended for visual reading. The iChemVELOCITY is not intended to be used as a Point of Care (POC) analyzer. The measurements are used to aid in the diagnosis of metabolic disorders, kidney function anomalies, urinary tract infections, and liver finction. Tests performed using the iChemVELOCITY are intended for clinical laboratory use and in vitro diagnostic use only.
Beckman Coulter has determined that there is a potential for incorrect settings to be installed on North American iChemVELOCITY Urine Chemistry Analyzers.    1. The installation of International settings can result in the generation of erroneous, false low results for some of the analytes at some concentrations.  2. The installation of colors different from those stated in the Instructions for Use (Colorless, Straw, Yellow, Amber, Red, Blue) for output settings will result in incorrect reporting of colors. For example, if Green is the color choice for the output setting instead of Blue, Green will be reported.
All Fielded Serial Numbers with North American Configuration settings
AL, AR, AZ, CA, CO, FL, GA, ID, IL, IN, KS, LA, MA, MD, MI, MN, NC, NE, NH, NJ, NY, OK, OR, PA, RI, SC, TX, UT, VA, WA, WY,  and Hawaii  Australia, Italy, Netherlands, Singapore, South Korea, United Kingdom, and   Vietnam
RESTORIS MCK TIBIAL BASEPLATE-RM/LL used in unicompartmental knee arthroplasty and knee replacements.
Incorrect product and/or label. Sizing is labeled incorrectly.
Worldwide Distribution -- US, Brazil, Guatemala, Ecuador, Malaysia, Czech Republic, United Kingdom, Argentina, Honduras, Peru, Singapore, Denmark,   Iceland, Chile, Nicaragua, Venezuela, Japan, Egypt, Israel, Canada, Panama,   Taiwan, United Arab Emirates, Finland, Ireland, Mexico, Dominican Republic,   Hong Kong, Austria, France, Italy, Costa Rica, Trinidad and Tobago, Australia,   Bahrain, Georgia, Islamic Republic of Iran, El Salvador, Colombia, New Zealand, Belgium, Germany, Jordan, Norway, Russia, Pakistan, Slovakia,   Portugal, South Africa, Oman, Saudi Arabia, Poland, Slovenia, Qatar, Spain, Kenya, Lebanon, Mauritius, Netherlands, Sweden, Turkey, Kuwait, Malta,   Namibia, Romania, Switzerland, and Greece.
Capio RP; Model #M0068321010.    Intended for use in general suturing applications during open surgery to assist in the placement of suture material in tissues at the operative site.
Potential for Capio sutures to break and /or detach.
Capio SLIM Box 5, Model #M0068318261;     Intended for use in general suturing applications during open surgery to assist in the placement of suture material in tissues at the operative site.
Capio CL; Model #M0068311350.    Indicated for the placement of suture in a variety of Transvaginal procedures.
Capio Standard Box 4 (Capio PC); Model #M0068312321.    Intended for use in general suturing applications during open or endoscopic  surgery to assist in the placement of suture material in tissues at the operative site.
Uphold Vaginal Support System; Model #M0068317080.    Indicated for tissue reinforcement in women with pelvic organ prolapse.
Posterior LITE w/ Capio SLIM; Model #M0068318150.    Indicated for tissue reinforcement in women with pelvic organ prolapse.
Capio Open Access Box 4 (Capio OPC); Model #M0068311251.    Intended for use in general suturing applications during open or endoscopic  surgery to assist in the placement of suture material in tissues at the operative site.
PFR Kit- Pinnacle, Posterior; Model #M0068317100.    Indicated for tissue reinforcement in women with pelvic organ prolapse.
PFR Kit- Pinnacle, Anterior Apical; Model #M0068317100.    Indicated for tissue reinforcement in women with pelvic organ prolapse.
Capio SLIM Suture Capturing Device, Model #M0068318250.    Intended for use in general suturing applications during open surgery to assist in the placement of suture material in tissues at the operative site.
Uphold LITE w/ Capio SLIM; Model #M0068318170.    Indicated for tissue reinforcement in women with pelvic organ prolapse.
The products were distributed to the following US states: CA, CT, GA, IL, KY, MA, MD, MO, PA, TX, WA, and WI.  The products were distributed to the following foreign countries:  Australia, Brazil, Canada, China, Costa Rica, India, Japan, Mexico, The Philippines, Russia, South Korea, South Africa, Switzerland, and Uruguay.
MicroVue BAP EIA, Model 8012, provides a quantitative measure of bone-specific alkaline phosphatase (BAP) activity in serum.
There is a possibility of low volume and/or leaking standard bottles.
FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2), Laboratory Automation System
Module may freeze without generating user warning. There is a potential risk in delay of sample processing, leading to delayed delivery of test results to patients.
Serial Numbers:   Accelerator a3600 -   ACP.150  ACP.185  ACP.186  ACP.192  ACP.202  ACP.214    FlexLab - FLX.0165  FLX.0127  FLX.0128  FLX.0133  FLX.0157  FLX.0160  FLX.0181    Aptio Automation -  AP2.0054  AP2.0056  AP2.0060  AP2.0078  AP2.0095    Part Numbers of impacted sample tube carriers: 721501001 for 43 mm carriers, and 0A00006957 for 40 mm carriers
Medtronic Prestige LP(TM) Cervical Disc System with Streamlined Instruments, DRILL GUIDES:  a) REF 6975205, 5mm  b) REF 6975206, 6mm  c) REF 6975207, 7mm    Product Usage:  The PRESTIGE LP  reusable instruments are intended for the surgical implantation of the PRESTIGE LP  Cervical Disc. Medtronic reusable instruments must be sterilized prior to initial use and must be cleaned and sterilized prior to each re-use.
The firm received complaints of drill bits breaking during use with the Prestige LP(TM) Cervical Disc System.  Subsequent investigation demonstrated the interaction of the drill guide and the drill bit may lead to drill bit breakage.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Worldwide distribution. US nationwide, Netherlands, Mexico, Paraguay, Brazil, Argentina, Malaysia, Costa Rica, Chile, South Korea, and Canada.
Gentle Threads, Interference Screw; Model No. 905604, for soft tissue reattachment procedures in the ankle/foot and knee.
Specific lots of the device were overexposed during EtO sterilization. This may lead to revision due to infection from loss of sterile barrier during over-exposure cycle.
Gentle Threads, Interference Screw; Model No. 905605, for soft tissue reattachment procedures in the ankle/foot and knee.
Gentle Threads, Interference Screw; Model No. 905617, for soft tissue reattachment procedures in the ankle/foot and knee.
Gentle Threads, Interference Screw; Model No. 905608, for soft tissue reattachment procedures in the ankle/foot and knee.
Gentle Threads, Interference Screw; Model No. 905607, for soft tissue reattachment procedures in the ankle/foot and knee.
Gentle Threads, Interference Screw; Model No. 905615, for soft tissue reattachment procedures in the ankle/foot and knee.
PA, MA, TX, ME, UT, FL, KS, NH, KY and Foreign
Incorrect calibrator level listed in qualitative calibration steps
Distributed US Nationwide and Puerto Rico.
A change regarding the shelf life of a raw material was implemented without an appropriate submission of data demonstrating the continued efficacy of the product.
Lot LZ713, Syringe Blaster Lot LP632B, Exp 6/30/2018  Lot MZ542, Syringe Blaster Lot LP632B, Exp 6/30/2018  Lot MG933, Syringe Blaster Lot LP632B, Exp 6/30/2018  Lot MZ543, Syringe Blaster Lot MG253C, Exp 9/30/2018  Lot NJ581, Syringe Blaster Lot MG253C, Exp 9/30/2018  Lot NJ582, Syringe Blaster Lot NA438B, Exp 3/31/2019  Lot NP345, Syringe Blaster Lot NE101B, Exp 3/31/2019
Lot MZ538, Syringe Blister Lot MG253B, Exp 9/4/2018  Lot NJ580, Syringe Blister Lot MG253B, Exp 9/30/2018  Lot NK215, Syringe Blister Lot NE101A, Exp 3/31/2019  Lot NP343, Syringe Blister Lot NE101A, Exp 3/31/2019
Lot NY938, Syringe Blister Lot MN843, Exp 11/30/2018  Lot NP738, Syringe Blister Lot NE101A, Exp 3/31/2019  Lot PG629, Syringe Blister Lot NK216, Exp 5/31/2019  Lot PY817, Syringe Blister Lot PT888C, Exp 1/31/2020
Lot NZ535, Syringe Blaster Lot LP632A, Exp 6/30/2018  Lot PG631, Syringe Blaster Lot MX842B, Exp 2/28/2019  Lot NP739, Syringe Blaster Lot NE101B, Exp 3/31/2019  Lot PY818, Syringe Blaster Lot PT888A, Exp 1/31/2020
Lot NP737, Syringe Blister Lot NA438A, Exp 3/31/2019;  Lot PG628, Syringe Blister Lot  NF819A, Exp  3/31/2019;  Lot PY816, Syringe Blister Lot  PT888C, Exp  1/31/2020;  Lot NY939, Syringe Blister Lot, NA438A, Exp 3/31/2019
Lot LT830, Syringe Blister Lot LK692B, Exp 5/31/2018  Lot LZ706, Syringe Blister Lot LK692B, Exp 5/31/2018  Lot MG929, Syringe Blister Lot LK692B, Exp 5/31/2018  Lot MT037, Syringe Blister Lot MG253A, Exp 9/30/2018  Lot MZ441, Syringe Blister Lot MG253A, Exp 9/30/2018  Lot NJ289, Syringe Blister Lot MG253A, Exp 9/30/2018  Lot NJ579, Syringe Blister Lot NA438A, Exp 3/31/2019  Lot NP340, Syringe Blister Lot NA438A, Exp 3/31/2019
Distributed to accounts in 20 states: AL, CA, CO, FL, HI, ID, IL, MA, ME, MI, NJ, NV, NY, OH, OR, PA, SC, TX, UT, and VA. Foreign distribution to United Arab Emirates, Australia, Belgium, Brazil, Canada, Germany, Spain, Finland, France, Great Britain, Hungary, Ireland, Italy, Japan, Mexico, Netherlands, New Zealand, Portugal, Singapore, and South Africa.
Jasper Vektor, Class II Correction Appliance, Part No. 610-527R used for correcting class 2 malocclusions by applying light forces on the teeth using a tube, arch wire and stops.
The firm has received 106 complaints of the device breaking in the patient's mouth. Device breakage may cause injury to the patient.
Jasper Vektor, Class II Correction Appliance, Part No. 610-536 used for correcting class 2 malocclusions by applying light forces on the teeth using a tube, arch wire and stops.
Jasper Vektor, Class II Correction Appliance, Part No. 610-536L used for correcting class 2 malocclusions by applying light forces on the teeth using a tube, arch wire and stops.
Jasper Vektor, Class II Correction Appliance, Part No. 610-533 used for correcting class 2 malocclusions by applying light forces on the teeth using a tube, arch wire and stops.
Jasper Vektor, Class II Correction Appliance, Part No. 610-533R used for correcting class 2 malocclusions by applying light forces on the teeth using a tube, arch wire and stops.
Jasper Vektor, Class II Correction Appliance, Part No. 610-530 used for correcting class 2 malocclusions by applying light forces on the teeth using a tube, arch wire and stops.
Jasper Vektor, Class II Correction Appliance, Part No. 610-533Lused for correcting class 2 malocclusions by applying light forces on the teeth using a tube, arch wire and stops.
Jasper Vektor, Class II Correction Appliance, Part No. 610-500 used for correcting class 2 malocclusions by applying light forces on the teeth using a tube, arch wire and stops.
Jasper Vektor, Class II Correction Appliance, Part No. 610-527L used for correcting class 2 malocclusions by applying light forces on the teeth using a tube, arch wire and stops.
Jasper Vektor, Class II Correction Appliance, Part No. 610-530L used for correcting class 2 malocclusions by applying light forces on the teeth using a tube, arch wire and stops.
Jasper Vektor, Class II Correction Appliance, Part No. 610-530R used for correcting class 2 malocclusions by applying light forces on the teeth using a tube, arch wire and stops.
Jasper Vektor, Class II Correction Appliance, Part No. 610-527 used for correcting class 2 malocclusions by applying light forces on the teeth using a tube, arch wire and stops.
Jasper Vektor, Class II Correction Appliance, Part No. 610-536R used for correcting class 2 malocclusions by applying light forces on the teeth using a tube, arch wire and stops.
Syngo.plaza software VB10A model numbers: 10863171, 10863172, 10863173    Syngo.Plaza is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. It supports the physician in diagnosis and treatment planning. Syngo.plaza also supports storage and archiving of DICOM Structured reports. In a comprehensive imaging syngo.plaza integrates Hospital/Radiology Information Systems (HIS/RIS) to enable customer specific workflows. Syngo.plaza optionally uses a variety of advanced postprocessing applications.
Software upgrade to correct format of study dates and issues with Legacy Presentation States (annotations) in order to prevent potential patient misdiagnosis.
Syngo.plaza software       Syngo.Plaza is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. It supports the physician in diagnosis and treatment planning. Syngo.plaza also supports storage and archiving of DICOM Structured reports. In a comprehensive imaging syngo.plaza integrates Hospital/Radiology Information Systems (HIS/RIS) to enable customer specific workflows. Syngo.plaza optionally uses a variety of advanced postprocessing applications.
Cosentyx 150 mg/mL PFS 300 mg Dose NDC 00078-0639-98, 28 days supply
All lots remaining within expiry dispensed 12/01/2017 through 02/12/2018
Revlimid 15 mg oral cap NDC 59572-0415-21 28 days supply
Boost VHC Oral Liquid VAN #27 NDC 43900-0182-15 27 days supply
Praluent 75 mg Pen (2 pens/Pkg) NDC 00024-5901-02 28 days supply
Creon DR 24,000 Units Capsule #250 NDC 00032-1224-07 30 days supply
Pulmicort Respules 0.5 mg/2mL s, 30 days supply, NDC 00186-1989-04
Revlimid 25 mg oral cap NDC 59572-0425-21 28 days supply
Revlimid 10 mg oral cap NDC 59572-0410-28 28 days supply
Orkambi 100 mg/125 mg Tablets #112 NDC 51167-0700-02 28 days supply.
Tecfidera 240 mg capsule NDC 64406-0006-02 30 days supply
Polyethylene Glycol 3350, powder, for solution 527g BRE, Rx Only, 28 days supply, NDC 51991-0457-57
Pulmozyme 1 mg/mL Inh. Soln. #30 NDC 50242-0100-40 30 days supply.
Bethkis 300 mg/4 mL Ampule #56 NDC 10122-0820-56 56 days supply
Pediasure Liq. Vanilla G+G (CAN) #24 24 days supply, NDC 70074-0558-98
Stelara 90 mg/MI PFS NDC 57894-0061-03 84 days supply
Xalkori 250 mg cap NDC 00069-8140-20 30 days supply
Letrozole 2.5 mg tab NDC 51991-0759-33 30 days supply
Avonex 30 mcg/0.5 mL PFS Kit NDC 59627-0222-05 28 days supply
Sprycel 80 mg tablet NDC 00003-0855-22 30 days supply
Altera Handset NDC 83490-0678-05 56 days supply
Lupron Depot 22.5 mg 3 month Kit NDC 00074-3346-03 84 days supply
Cayston 75 mg Inh. Soln. SDV NDC 61958-0901-01 56 days supply
Repatha 140 mg/mL Sureclick AI 2-pk NDC 55513-0760-02 28 days supply
Sodium Chloride 3% Inh. 4 mL NEP #30 NDC 00487-9003-60 30 days supply.
Revlimid 20 mg oral cap NDC 59572-0420-21 28 days supply
OPDIVO 40 mg/4 mL SDV NDC 00003-3772-11 28 days supply
Ondansetron 8 mg tablet NDC 57237-0076-30 28 days supply
Temozolomide 250 mg NDC 43975-0257-05 28 days supply
Azithromycin 250 mg tablet #18 TEV NDC 50111-0787-66 28 days supply
Tasigna Capsules 150 mg NDC 00078-0592-87 28 days supply
Revlimid 5 mg oral cap NDC 59572-0405-28 28 days supply
Perjeta 420 mg/14 mL SDV Vials 50242-0145-01 21 days supply
Imatinib Mesylate Tablet 400 mg NDC 60505-2901-03 30 days supply
Promacta 50 mg tablet NDC 00078-0686-15 30 days supply
Sutent 50 mg capsules x28 NDC 00069-0550-38 42 days supply
Copaxone 40 mg Injection (12) NDC 68546-0325-12 28 days supply.
Temozolomide 20 mg NDC 43975-0253-05 28 days supply
Orkambi 200 mg/125 mg Tablets #112 NDC 51167-0809-01 28 days supply.
Bendeka 25 mg/mL 4 mL MDVPF NDC 63459-0348-04 28 days supply
Pomalyst 3 mg capsule NDC 59572-0503-21 28 days supply
Copaxone 20 mg Injection PFS (30) NDC 68546-0317-30 30 days supply.
Albuterol 0.083% Inh Sol. 30 days supply, Rx Only, 39183, NDC 76204-0200-60, 30
Cyclophosphamide 50 mg cap NDC 00054-0383-25 28 days supply
Cimzia 200 mg/mL PFS Kit #2 NDC 50474-0710-79 28 days supply.
Capecitabine 500 mg Tablet NDC 00378-2512-78 28 days supply and 21 days supply
Dexamethasone 4 mg tablet NDC 49884-0087-01 28 days supply
Kalydeco 150 mg tablet blister, 28 days supply, Rx Only, 39183, NDC 51167-0200-01
Capecitabine 150 mg Tablet NDC 00378-2511-91 28 days supply
Sprycel 100 mg tablet NDC 00003-0852-22 30 days supply
Dupixent 300 mg/2 mL PFS #2 w/ NS NDC 00024-5914-01 28 days supply
Gleevec 100 mg tablet NDC 00078-0401-34 30 days supply
MVW Complete Softgels NDC 58204-0004-00 30 days supply; MVW Complete Chew Vitamin Grape NDC 58204-0004-15 30 days supply.
Sutent 37.5 mg capsules x28 NDC 00069-0830-38 28 days supply
Kitabis Pak 300 mg/5 mL Soln PARI #56 NDC 24492-0850-56 56 days supply
Botox 100 Units Vial NDC 00023-1145-01 90 days supply.
Prolia 60 mg/1 mL PF syringe NDC 55513-0710-01 180 days supply.
Zarxio 300 mcg/0.5 mL PFS NDC 14 days supply
Glatiramer Acetate 40 mg/mL NDC 00378-6961-12 28 days supply
Enbrel PFS 50 mg/mL Inj #4 NDC 58406-0435-04 28 days supply;
Ibrance 125 mg cap NDC 00069-0189-21 28 days supply
Kisqali 600 Dose 63 tablet 200 mg NDC 00078-0874-63 28 days supply
Otezla 30 mg tablet NDC 59572-0631-06 30 days supply;
Taltz 80 mg/mL Pen 1-pk NDC 00002-1445-11 28 days supply
Humira Pen Sub-q Kit a.) 40 mg/0.8 mL (NDC 00074-4339-02); Humira Pen Psor Kit b.) 40 mg/0.8 mL (NDC 00074-4339-07) 28 day supply, Rx Only,
Xtandi 40 mg capsule NDC 00469-0125-99 30 days supply
Xolair 150 mg SDV NDC 50242-0040-62 28 days
Worldwide Distribution - USA (nationwide) Distribution and to the states of :  NJ, NY, OH, PA, and TX., and to the countries of : Canada, South Korea, Thailand, Australia and Taiwan.
Transonic ADT1018 Flow QC Clear Advantage Tubing, Catalog No. ADT1018, ADT1018-40    The device is indicated for use as part of an extracorporeal blood circuit for hemodialysis when a monitor will be used to make access flow, recirculation, and/or cardiac output measurements during the patient s hemodialysis treatment.
The sterility of the device cannot be assured. There is a potential for an increased risk of infection.
Nationwide Distribution to states of: AZ, UT, WI, NJ, CT, TX, PA, VA, MN, MA, MO, FL, and CA.
PICC Kit, Product Code: AMS-7063-1    Convenience kit for the insertion of PICCs into the vascular system.
Potential friction holes may affect the sterility of the product.
PICC Insertion Tray, Product Code: AMS-7192CS-3    Convenience kit for the insertion of PICCs into the vascular system.
Maximum Barrier Tray, Product Code: MCITX-1    Convenience kit for the insertion of PICCs into the vascular system.
PICC Tray, Product Code: AMS-9093CP     Convenience kit for the insertion of PICCs into the vascular system.
Maximum Barrier Tray, Product Code: AMS-9018CP    Convenience kit for the insertion of PICCs into the vascular system.
PICC Insertion Tray, Product Code: AMS-7192CS-4    Convenience kit for the insertion of PICCs into the vascular system.
Neonatal PICC Tray, Product Code: AMS-8010CP-1    Convenience kit for the insertion of PICCs into the vascular system.
Maximum Barrier Insertion Tray, Product Code: AMS-9152CP    Convenience kit for the insertion of PICCs into the vascular system.
Thumper Cardiopulmonary Resuscitator, Model 1007CCV, Catalog No. 15370  Product Usage:  The device is used to perform Cardiopulmonary Resuscitation (CRP) on adult patients and only adult patients in cases of clinical death as defined by a lack of spontaneous breathing and pulse.
Manuka Honey Wound Gel  Catalogue No: 716597    Product Usage:  Helps maintain a moist wound environment which has shown to be conducive to wound healing Ideal for minor scalds and burns, minor cuts, lacerations and minor abrasions
Incorrect gel part number listed in a master manufacturing record
US Nationwide Distribution in the states of West Virginia and Puerto Rico
Lipase, Catalog number: LI3837; GTIN: 05055273204230 and Catalog number: LI8361; GTIN: 05055273214284    Product Usage:  For Professional Use for the quantitative in vitro determination of Lipase in human serum and plasma. Lipase measurements are used in the diagnosis and treatment of diseases of the pancreas such as acute pancreatitis and obstruction of the pancreatic duct.
Randox  has now released further steps to avoid contamination of the Lipase Assay on Rx  instruments.
US Nationwide Distribution to accounts in 21 states: AZ, CA, CO, ID, IL, KS, MA, MI, MS, NC, NY, OH, OK, PA, RI, TN, TX, UT, VA, WA, WI; and PR.
Fabius GS Premium, anesthesia machine, catalog no. 8607000    Product Usage:  The products are inhalation anesthesia machines for use in operating, induction and recovery rooms. They may be used with O2, N2O, and AIR supplied by a medical gas pipeline system or by externally mounted gas cylinders. Fabius series anesthesia machines are equipped with an electrically driven and electronically controlled ventilator and monitors for airway pressure (P), volume (V), and inspiratory oxygen concentration (FiO2).
The automatic ventilation may fail if the position detection of the motor is disturbed. If the ventilator cover is damaged, manual ventilation may also fail.
Fabius Tiro M, anesthesia machine, catalog no. 8608400    Product Usage:  The products are inhalation anesthesia machines for use in operating, induction and recovery rooms. They may be used with O2, N2O, and AIR supplied by a medical gas pipeline system or by externally mounted gas cylinders. Fabius series anesthesia machines are equipped with an electrically driven and electronically controlled ventilator and monitors for airway pressure (P), volume (V), and inspiratory oxygen concentration (FiO2).
Fabius Tiro, anesthesia machine, catalog no. 8606000    Product Usage:  The products are inhalation anesthesia machines for use in operating, induction and recovery rooms. They may be used with O2, N2O, and AIR supplied by a medical gas pipeline system or by externally mounted gas cylinders. Fabius series anesthesia machines are equipped with an electrically driven and electronically controlled ventilator and monitors for airway pressure (P), volume (V), and inspiratory oxygen concentration (FiO2).
Fabius MRI, anesthesia machine, catalog no. 8607300    Product Usage:  The products are inhalation anesthesia machines for use in operating, induction and recovery rooms. They may be used with O2, N2O, and AIR supplied by a medical gas pipeline system or by externally mounted gas cylinders. Fabius series anesthesia machines are equipped with an electrically driven and electronically controlled ventilator and monitors for airway pressure (P), volume (V), and inspiratory oxygen concentration (FiO2). This device can also be used in MRI scanner rooms with magnets 1.5 tesla and 3 tesla at a fringe field strength of 40 mtesla or less.
Shipped to customers nationwide and Canada.
Energique, Dietary Supplement, Enervimin CNCR Focus,  Dist. by Energique Inc.. Woodbine, IA 51579
Multiple products marketed as dietary supplements are unapproved new drugs based on disease claims or routes of administration.
Energique, Herbal Supplement, Octocom,; Dist. by Energique, Inc. Woodbine, IA 51579
Peaceful Mountain -Stomach Rescue - Dietary supplement - Elemental silver (45 ppm) 2.7 mg; Dist. by Peaceful Mountain, Inc. Woodbine, IA 51579
Peaceful Mountain, Nasal Rescue, Dietary Supplement, Natural Sinus Support, Dist. by Peaceful Mountain, Inc. Woodbine, IA 51579
Distributed to accounts in 7 states: AL, CA, GA, NE, NV, NY, and TX. International distribution to Japan, Korea, and Taiwan.
Connecting Tube - Female to Male Luer Lock, HPCT8.8-60-M-FM-BNS    Product Usage:  The connecting tube is intended to be a conduit between a fluid reservoir and a vascular catheter in the patient. The connecting tube may be used during angiographic procedures to connect radiographic contrast power injector to a vascular catheter, arterial pressure monitoring, and fluid infusion.
Cap-adapter assembly of the device may potentially not be adequately tightened, possibly leading to fluid leakage from or air aspiration into the connecting tube.
Connecting Tube - Female to Male Luer Lock, HPCT8.8-80-M-FM    Product Usage:  The connecting tube is intended to be a conduit between a fluid reservoir and a vascular catheter in the patient. The connecting tube may be used during angiographic procedures to connect radiographic contrast power injector to a vascular catheter, arterial pressure monitoring, and fluid infusion.
Connecting Tube - Female to Male Luer Lock, HPCT8.8-100-M-FM    Product Usage:  The connecting tube is intended to be a conduit between a fluid reservoir and a vascular catheter in the patient. The connecting tube may be used during angiographic procedures to connect radiographic contrast power injector to a vascular catheter, arterial pressure monitoring, and fluid infusion.
Connecting Tube - Female to Male Luer Lock, HPCT8.8-60-M-FM    Product Usage:  The connecting tube is intended to be a conduit between a fluid reservoir and a vascular catheter in the patient. The connecting tube may be used during angiographic procedures to connect radiographic contrast power injector to a vascular catheter, arterial pressure monitoring, and fluid infusion.
Connecting Tube - Female to Male Luer Lock, HPCT8.8-30-M-FM    Product Usage:  The connecting tube is intended to be a conduit between a fluid reservoir and a vascular catheter in the patient. The connecting tube may be used during angiographic procedures to connect radiographic contrast power injector to a vascular catheter, arterial pressure monitoring, and fluid infusion.
Connecting Tube - Female to Male Luer Lock, HPCT8.8-120-M-FM    Product Usage: The connecting tube is intended to be a conduit between a fluid reservoir and a vascular catheter in the patient. The connecting tube may be used during angiographic procedures to connect radiographic contrast power injector to a vascular catheter, arterial pressure monitoring, and fluid infusion.
Worldwide Distribution - US Nationwide in the states of GA, CT, LA, MD, WY, IN, MD, FL, and France
Medtronic ZEVO(TM) Anterior Cervical Plate System SLOT SCREW, REF 7710015, Size 4.5mm x 15mm    Product Appliance, fixation, spinal intervertebral body
Slot screw had an overall length of 15mm, but per the specification, the screw should have an overall length of approximately 17mm.
ZYMUTEST HIA IgGAM; REF Number: RK040D; UDI: 03663537018770 a qualitative screening assay intended for the global detection of heparin- dependent antibodies, whether the isotype is: IgG, IgM and IgA, in human plasma, by clinical laboratories.
Incorrect package insert indicating use of the kits with plasma, serum, and other biological fluids. The kits should only be used with plasma.
ZYMUTEST HIA MonoStria qualitative screening assay intended for the global detection of heparin-dependent antibodies, whether the isotype is: IgG, IgM and IgA, in human plasma, by clinical laboratories. p IgGAM; REF Number: RK041D; UDI: 03663537046810
ZYMUTEST HIA MonoStrip IgG; REF Number: RK041A; UDI: 03663537046803 a qualitative assay intended for the detection of heparin-dependent antibodies of the IgG isotype, in human plasma, by clinical laboratories. It is intended for in vitro diagnostic use.
WA, GA, SC, FL, NJ, LA, CA, TX, NV, NC, PA, MO, CO, OR, MT, MA, UT, NE, AZ, MO, NY, OH, VA, MD.
Third Eye Kratom Red in 300 capsule plastic  bottles.    Manufactured for Raw Form Organics, Las Vegas, NV 89118 by  Triangle Pharmanaturals, LLC, Las Vegas, NV 89119
All Kratom products manufactured, processed, packed, and/or held by Triangle Pharmanaaturals LLC have the potential to be contaminated with Salmonella
Lifted Kratom Red Maeng Da in 45 gram powder, 150 capsule and 300 capsule plastic bottles..    Manufactured for Raw Form Organics, Las Vegas, NV 89118 by  Triangle Pharmanaturals, LLC, Las Vegas, NV 89119
Chameleon Kratom Formula 27 in 60 capsule plastic bottles;    Manufactured for Raw Form Organics, Las Vegas, NV 89118 by  Triangle Pharmanaturals, LLC, Las Vegas, NV 89119
Molecule Kratom Red Maeng Da in 20 capsule, 80 capsule, 45 gram, and 250 gram plastic bottles;    Manufactured for Raw Form Organics, Las Vegas, NV 89118 by  Triangle Pharmanaturals, LLC, Las Vegas, NV 89119
Live Well Kratom Red Maeng Da in 150 capsule and 300 capsule plastic bottles.    Manufactured for Raw Form Organics, Las Vegas, NV 89118 by  Triangle Pharmanaturals, LLC, Las Vegas, NV 89119
Raw Form Organics Maeng Da Kratom Amethyst Gold in 150 capsule and 300 capsule plastic bottles;    Manufactured for Raw Form Organics, Las Vegas, NV 89118 by  Triangle Pharmanaturals, LLC, Las Vegas, NV 89119
Molecule Kratom Red Malay in 20 capsule, 80 capsule, 45 gram, and 250 gram plastic bottles;    Manufactured for Raw Form Organics, Las Vegas, NV 89118 by  Triangle Pharmanaturals, LLC, Las Vegas, NV 89119
Molecule Kratom Super Green Malay in 20 capsule, 80 capsule, 45 gram, and 250 gram plastic bottles;    Manufactured for Raw Form Organics, Las Vegas, NV 89118 by  Triangle Pharmanaturals, LLC, Las Vegas, NV 89119
Live Well Kratom Green Maeng Da in 150 capsule and 300 capsule plastic bottles.    Manufactured for Raw Form Organics, Las Vegas, NV 89118 by  Triangle Pharmanaturals, LLC, Las Vegas, NV 89119
Lifted Kratom Green Maeng Da in 45 gram powder, 150 capsule and 300 capsule plastic bottles.    Manufactured for Raw Form Organics, Las Vegas, NV 89118 by  Triangle Pharmanaturals, LLC, Las Vegas, NV 89119
Molecule Kratom Gold Bali in 20 capsule, 80 capsule, 45 gram, and 250 gram plastic bottles;    Manufactured for Raw Form Organics, Las Vegas, NV 89118 by  Triangle Pharmanaturals, LLC, Las Vegas, NV 89119
Third Eye Kratom White in 300 capsule plastic bottles;    Manufactured for Raw Form Organics, Las Vegas, NV 89118 by  Triangle Pharmanaturals, LLC, Las Vegas, NV 89119
Lifted Kratom White Maeng Da in 45 gram powder, 150 capsule and 300 capsule plastic bottles.    Manufactured for Raw Form Organics, Las Vegas, NV 89118 by  Triangle Pharmanaturals, LLC, Las Vegas, NV 89119
Molecule Kratom White Maeng Da in 20 capsule, 80 capsule, 45 gram powder, and 250 gram powder plastic bottles;    Manufactured for Raw Form Organics, Las Vegas, NV 89118 by  Triangle Pharmanaturals, LLC, Las Vegas, NV 89119
Third Eye Kratom Bali in 300 capsule plastic  bottles.    Manufactured for Raw Form Organics, Las Vegas, NV 89118 by  Triangle Pharmanaturals, LLC, Las Vegas, NV 89119
Raw Form Organics Maeng Da Kratom Ruby Red;  R150 capsule and 300 capsule plastic bottles;    Manufactured for Raw Form Organics, Las Vegas, NV 89118 by  Triangle Pharmanaturals, LLC, Las Vegas, NV 89119
Raw Form Organics Maeng Da Kratom Emerald Green;  150 capsule and 300 capsule plastic bottles;      Manufactured for Raw Form Organics, Las Vegas, NV 89118 by  Triangle Pharmanaturals, LLC, Las Vegas, NV 89119
Raw Form Organics Maeng Da Kratom Ivory White;  150 capsule and 300 capsule plastic bottles;    Manufactured for Raw Form Organics, Las Vegas, NV 89118 by  Triangle Pharmanaturals, LLC, Las Vegas, NV 89119
Molecule Kratom Green Maeng Da in 20 capsule, 80 capsule, 45 gram, and 250 gram plastic bottles;    Manufactured for Raw Form Organics, Las Vegas, NV 89118 by  Triangle Pharmanaturals, LLC, Las Vegas, NV 89119
Naturally Kratom Bali Gold in 6 capsule bags.    Manufactured for Raw Form Organics, Las Vegas, NV 89118 by  Triangle Pharmanaturals, LLC, Las Vegas, NV 89119
Naturally Kratom White Maeng Da in 6 capsule bags.    Manufactured for Raw Form Organics, Las Vegas, NV 89118 by  Triangle Pharmanaturals, LLC, Las Vegas, NV 89119
Molecule Kratom White Borneo in 20 capsule, 80 capsule, 45 gram powder, and 250 gram powder plastic bottles;    Manufactured for Raw Form Organics, Las Vegas, NV 89118 by  Triangle Pharmanaturals, LLC, Las Vegas, NV 89119
Chameleon Kratom Formula 51 in 60 capsule plastic bottles;    Manufactured for Raw Form Organics, Las Vegas, NV 89118 by  Triangle Pharmanaturals, LLC, Las Vegas, NV 89119
Lifted Kratom Gold Bali in 45 gram powder, 150 capsule and 300 capsule plastic bottles.    Manufactured for Raw Form Organics, Las Vegas, NV 89118 by  Triangle Pharmanaturals, LLC, Las Vegas, NV 89119
Naturally Kratom Green Malay in 6 capsule bags..    Manufactured for Raw Form Organics, Las Vegas, NV 89118 by  Triangle Pharmanaturals, LLC, Las Vegas, NV 89119
Naturally Kratom Red Malay in 6 capsule bags.    Manufactured for Raw Form Organics, Las Vegas, NV 89118 by  Triangle Pharmanaturals, LLC, Las Vegas, NV 89119
The product was distributed to the following US state: MO.  The product was distributed to the following foreign countries: France, Germany, Switzerland, and Thailand.
CARDIOHELP Gas Bottle Holder HKH 8880, Product Code/Part Number 70105.0901    Product Usage:  The Cardiohelp Gas Bottle (or Cylinder) Holder HKH 8880 is an accessory for the CARDIOHELP System and required for inter-hospital patient transport in aircraft and road vehicles (mobile intensive care units and ambulances). Inter-hospital patient transport is transport of the patient between clinics, where the clinical environment is left (e.g., transport in vehicles such as ambulances or aircraft). The gas cylinder holder serves to hold an oxygen cylinder in aircraft.
There is a possibility for the clamps of the gas bottle holder to crack or break when exposed to strong vibrations.
Distributed to the states of CA, FL, NC, NE, NY, and WA.
Hemodynamic monitoring system (HMS), comprised of a Patient Interface Module (Part Number 58401-000 and a User Interface Module (Part Number 58403-000).    Intended for patients for whom the monitoring of continuous cardiac output is indicated for diagnostic and prognostic evaluation by a clinician in the hospital.
When continuous cardiac output monitoring with a  pulmonary artery catheter is placed in the  Pause  mode,  the catheter thermal coil may continue while in pause mode.
Worldwide Distribution - US Nationwide and the country of Canada
Baxter Sigma Spectrum Infusion Pump with Master Drug Library (Version 6) 35700BAXRP    Product Usage:  The Baxter Sigma Spectrum Infusion Pump with master Drug Library is intended to be used for the controlled administration of fluids. These fluids may includes pharmaceutical drugs, blood, blood products and mixture if required patient therapy. The intended routes of administration consist of the following clinically accepted routes: intravenous, arterial, subcutaneous, intrathecal, epidural or irrigation of fluids. Spectrum infusion pump is intended to be used in conjunction with legally marketed intravenous administration sets and medications provided by user. The Spectrum and Spectrum with MAster Drug Library is intended to reduce operator interaction through automated programming thereby helping to reduce errors associated with complex device programming.
Service technician improperly documented final release testing on product, indicating that the full battery of release tests were performed when, in fact, several tests were omitted. he omitted tests include air-in-line detection at 400ml/hr and 800ml/hr and verification of upstream occlusion detection at 800ml/hr. Improper detection of air-in-line or upstream occlusion may result in serious adverse health consequences.
Baxter Sigma Spectrum Infusion Pump with master Drug Library (Version 6) 35700BAX    Product Usage:  The Baxter Sigma Spectrum Infusion Pump with master Drug Library is intended to be used for the controlled administration of fluids. These fluids may includes pharmaceutical drugs, blood, blood products and mixture if required patient therapy. The intended routes of administration consist of the following clinically accepted routes: intravenous, arterial, subcutaneous, intrathecal, epidural or irrigation of fluids. Spectrum infusion pump is intended to be used in conjunction with legally marketed intravenous administration sets and medications provided by user. The Spectrum and Spectrum with MAster Drug Library is intended to reduce operator interaction through automated programming thereby helping to reduce errors associated with complex device programming.
Baxter Sigma Spectrum Infusion Pump with Master Drug Library (Version 6) 35700BAXR    Product Usage:  The Baxter Sigma Spectrum Infusion Pump with master Drug Library is intended to be used for the controlled administration of fluids. These fluids may includes pharmaceutical drugs, blood, blood products and mixture if required patient therapy. The intended routes of administration consist of the following clinically accepted routes: intravenous, arterial, subcutaneous, intrathecal, epidural or irrigation of fluids. Spectrum infusion pump is intended to be used in conjunction with legally marketed intravenous administration sets and medications provided by user. The Spectrum and Spectrum with MAster Drug Library is intended to reduce operator interaction through automated programming thereby helping to reduce errors associated with complex device programming.
Baxter Sigma Spectrum Infusion Pump with Master Drug Library (Version 6) 35700BAXRE    Product Usage:  The Baxter Sigma Spectrum Infusion Pump with master Drug Library is intended to be used for the controlled administration of fluids. These fluids may includes pharmaceutical drugs, blood, blood products and mixture if required patient therapy. The intended routes of administration consist of the following clinically accepted routes: intravenous, arterial, subcutaneous, intrathecal, epidural or irrigation of fluids. Spectrum infusion pump is intended to be used in conjunction with legally marketed intravenous administration sets and medications provided by user. The Spectrum and Spectrum with MAster Drug Library is intended to reduce operator interaction through automated programming thereby helping to reduce errors associated with complex device programming.
Baxter Sigma Spectrum Infusion Pump with master Drug Library (Version 6) 35700BAXL    Product Usage:  The Baxter Sigma Spectrum Infusion Pump with master Drug Library is intended to be used for the controlled administration of fluids. These fluids may includes pharmaceutical drugs, blood, blood products and mixture if required patient therapy. The intended routes of administration consist of the following clinically accepted routes: intravenous, arterial, subcutaneous, intrathecal, epidural or irrigation of fluids. Spectrum infusion pump is intended to be used in conjunction with legally marketed intravenous administration sets and medications provided by user. The Spectrum and Spectrum with MAster Drug Library is intended to reduce operator interaction through automated programming thereby helping to reduce errors associated with complex device programming.
Worldwide Distribution - US Nationwide in the states of OH, FL, NH, TX, Sweden, Canada
IMRIS IMRI 1.5T AND 3T S System    Product Usage:  The IMRIS intraoperative MRI systems are traditional MRI systems that have been suspended on an overhead rail system. and is designated to operative inside an RF shielded room to facilitate intraoperative and multi room use.
The DC power to the IFOSS collision detector control panel at your facility is being adversely affected by the magnetic field. Our investigation shows the magnetic field is causing the IFOSS control panel to malfunction.
The products were distributed to the following US states: FL, MO, and PA.
ATTUNE Revision CRS Femoral LT SZ 5 Cemented, Catalog No. 150440105, Femoral Revision Implant, Knee
There may be burrs on the extraction hole threads.
Lot Number HC1179, GTIN Number 10603295042181; Lot Number HC1183, GTIN Number 10603295042181
ATTUNE Revision CRS Femoral RT SZ 5 Cemented, Catalog No. 150440205, Femoral Revision Implant, Knee
Lot Number HD6516, GTIN Number 10603295042280
POWERPORT ClearVUE Slim with Smooth Septum, 6F ChronoFlex Silk, Polyurethane Catheter with Open Suture Holes, REF 5676301
The Patient ID Card packaged with the POWERPORT ClearVUE Implantable Port with Smooth Septum contains incorrect port flushing instructions.
POWERPORT ClearVUE isp Implantable Port With Smooth Septum and Attachable 8F Polyurethane Open-Ended Single-Lumen Venous Catheter Custom Kit, REF CP00004
POWERPORT(R) ClearVUE(R) isp with Smooth Septum, 6F ChronoFlex(TM), Polyurethane Catheter, REF 1666362
POWERPORT ClearVUE Slim with Smooth Septum, 8F ChronoFlex,  Polyurethane Catheter, REF 1678300
POWERPORT ClearVUE Slim Implantable Port with Smooth Septum and Attachable 8F Polyurethane Open-Ended Single-Lumen Venous Catheter Custom Kit, REF CP00005
POWERPORT ClearVUE Slim with Smooth Septum, 6F ChronoFlex, Polyurethane Catheter with Open Suture Holes, REF 1676301
POWERPORT ClearVUE Slim with Smooth Septum, 6F ChronoFlex Silk, Polyurethane Catheter, REF 5676300
POWERPORT ClearVUE isp with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter, REF 5668362
POWERPORT ClearVUE isp with Smooth Septum, 6F ChronoFlex, Polyurethane Catheter, REF 5666362
POWERPORT ClearVUE Slim with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter with open suture holes, REF 5678301
POWERPORT ClearVUE Slim with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter with Open Suture Holes, REF 1678301
POWERPORT ClearVUE Slim with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter with open suture holes, REF 5678300
POWERPORT ClearVUE isp with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter, REF 1668362
POWERPORT ClearVUE Slim with Smooth Septum, 6F ChronoFlex Silk, Polyurethane Catheter, REF 1676300
Retractor f/Sciatic Nerve; Part number: 03.100.013; UDI: 10886982070623
There is a potential for microspores to form on the hollow handle of the Sciatic Nerve Retractor. The pores may increase in size, allowing fluid to enter the hollow handle.
Retractor f/Sciatic Nerve Long; Part number: 03.100.014; UDI: 10886982070630
Recalled product was distributed to retail stores in AZ, IA, ID, IL, KS, MI, UT, and WY.
Dragon Maeng Da Kratom Powder: 60 g and 150 g bottle. Dragon Maeng Da Kratom: 200-, 80-, and 40-ct x 500mg capsules in bottles.
Samples collected by public health officials found the presence of Salmonella.
Dragon Bali Kratom Powder: 60g Bottle. Dragon Bali Kratom Capsules in bottles:200 ct 500mg, 80 ct x 500, 40 ct x 500mg and 20 ct x 500 mg pouch.
Dragon Malaysian Kratom Powder: 150 g bottle. Dragon Malaysian Kratom: 200-, 80-, and 40-ct x 500mg capsules in bottles. Dragon Malaysian Kratom: 20-ct x 500 mg capsules in pouches.
Dragon Ultra Ehanced Indo Extract 4-ct x 500 mg capsules in pouches.
Worldwide Distribution - USA (nationwide) and to the counties of : Canada and Taiwan.
Ondamed Biofeedback Device, Model No. 001-00-0101    The product is a battery powered biofeedback device that is indicated for relaxation training and muscle re-education and prescription use.
The firm was marketing the Ondamed System in the US without marketing clearance. As a corrective action, the firm revised its device design to comply with regulations. The firm has notified customers that an upgrade for the device is now available, which includes the addition of direct readout and audio signals for heart rate, and visual patient readout of blood oxygen content SpO2.
Distributed to accounts in AL, AR, CA, DC, FL, IL, LA, MO, NC, PA, SC, TX, and WA.
BEQ-TOP 40700 HUNTINGTON, Catalog No. 701062899
The Better Bladder device provided as part of some custom tubing kits has been recalled by its manufacturer. Seal separation from the housing may allow air to enter the housing and collapse the balloon. This may increase resistance to flow in the venous line and cause a drop in ECMO circuit blood flow.
BEQ-TOP 22301, Custom Tubing Kit, Catalog No. 701049513
BEQ-TOP 22300, Custom Tubing Kit, Catalog No. 701049504
NICU ECC Pack BEQ-TOP 39202, Custom Tubing Kit, Catalog No. 701067313R01
BEQ-TOP 5210 ECC Set -  Respiratory, Custom Tubing Kit, Catalog No. 701055604R01
BEQ-TOP 50900 Custom ECC Pack-Neonatal 1/4, Custom Tubing Kit, Catalog No. 709000069R02
BEQ-TOP 38900 ECC PACK, Custom Tubing Kit, Catalog No. 701056368
BEQ-TOP 41201 ECC 3/8 PUMP PAC, Custom Tubing Kit, Catalog No. 701064867
BEQ-TOP 50903 Custom ECC Pack-Pedriatric  , Custom Tubing Kit, Catalog No. 709000078
BEQ-TOP 24500 ADULT ECC, Custom Tubing Kit, Catalog No. 701050253
Better Bladder Pack, Custom Tubing Kit, Catalog No. 709000370
BO-TOP 20700 SMALL PATIENT 3/8, Custom Tubing Kit, Catalog No. 701050966
BO-TOP 20705 SMALL PATIENT 1/4, Catalog No. 701053486
BEQ-T 9410 Lurie Chldns Small 1/4, Custom Tubing Kit, Catalog No. 709000430
BEQ-TOP 24202 ADULT ECC, Catalog No. 701054295
BEQ-TOP 49101 Childrens Large ECC Pack, Custom Tubing Kit, Catalog No. 701067069R01
BEQ-TOP 22702 ECC W/HMOD  30000, Catalog No. 701051179
PACK, Custom Tubing Pack with Bioline Coating, Catalog No. 701053845
BEQ-TOP 8504 1/4X1/4 PACK W/QP, Custom Tubing Kit, Catalog No. 701066949R02
BEQ-T 25502 1/4 Better Bladder  , Custom Tubing Kit, Catalog No. 709000434
BEQ-TOP 27610 ECC PACK 3/8, Custom Tubing Kit, Catalog No. 701065622
BEQ-TOP 25500 ECC 3/8 w/QiD, Custom Tubing Kit, Catalog No. 701052461
BO-TOP 13901 RAPID RESPONSE, Custom Tubing Kit, Catalog No. 701054874
Adult ECC Pack BEQ-TOP 22300, Catalog No. 701049504
Small Patient ECC Pack BEQ-TOP 22301, Catalog No. 701049513
ECC Small - Respiratory BEQ-TOP 5210, Custom Tubing Kit, Catalog No. 701055604
US Nationwide Distribution in the states of AL, AZ, CA, FL, GA, IL, MA, NJ, NM, NY, TX
Distal tips of the probes may detach from the probe shaft during use.
not functioning properly. The corrected values modified in the report are neither saved, nor printed, nor sent to the information system. The system will still use original values.
Smoked Salmon Spread   5 lb. bulk units; Simply Superior Smoked Salmon Spread   5 oz units; and Morey s Smoked Salmon Spread   6 oz units; Deli Cups, Deli Tubs
Superior Foods Company is voluntarily recalling a specific lot of Smoked Salmon Spreads that were produced on March 26, 2018, due to potential contamination with Listeria monocytogenes.
Smoked Salmon Spread   5 lb. bulk units   Code Number: 68487   Sell by Date: 4/25/18   Lot  Number 0728-2 UPC #043823684873  Simply Superior Smoked Salmon Spread   6X5 oz units   Code Number: 92379   Sell by  Date: 4/25/18   Lot Number 0728-2 UPC #043823923798  Morey s Smoked Salmon Spread   6x6 oz units   Code Number: 92503   Sell by Date:  4/25/2018   Lot Number 0728-2 UPC #043823925037
Whole Wheat Chocolate Animal Cookies;  5 oz. pouch, 5 lb. Corporate bags  UPC: 8 58950 00508 6    Ingredients: Whole Wheat Flour, Unbleached Enriched Wheat Flour (niacin, reduced iron, thiamine mononitrate, riboflavin, folic acid). soluble Corn Prebiotic Fiber, Granulated sugar, Expeller Expressed Canola Oil, cocoa powder, Unsweetened Chocolate, natural Flavor, Baking Soda, Salt, Pure Vanilla Extract.    Contains: Wheat    Packed in a facility that also processes peanuts, tree nuts, milk, wheat, egg and soy.    distributed by NatureBox  Redwood City, CA    Vanilla cookies ingredients contain Soy Lecithin:  Contains: Wheat and Soy
While packing from a bulk bin of whole wheat chocolate animal cookies, 2 whole wheat vanilla animal cookies were discovered. The vanilla cookies contain soy lecithin that is not declared on the chocolate cookie label.
Lot code 18073  best by date of 9/14/18.
AEQUALIS HUMERAL NAIL DRILL  BIT, REF 7020140    Product Usage:  The Aequalis Humeral Nail system is intended to provide temporary stabilization of various types of proximal and/or diaphyseal fractures of the humerus. Types of fractures include, but are not limited to, non-unions, malunions, malalignments, pathological fractures, and impending pathological fractures. Examples of specific indications according to AO classification include Type A-Fractures, dislocated, Type B Fractures, dislocated, Type C-Fractures, with intact humeral head, or Humeral Fractures according to Neer-Classification (2, 3 and 4 part fractures).
Drill bit tips without new BargerGard tip protector may puncture through sterile packaging.
The products were distributed to the following US states: CA, FL, GA, IA, IL, OH, TN, and VA.  The products were distributed to the following foreign countries: Canada, United Kingdom, and Malta.
Sterile Aquasonic 100 Ultrasound Transmission Gel, 20 grams, Model Number 01-01-4, 400 packets/case
There is a potential for the gel packets to have leaks in the packet seal.
Wet-Field Hemostatic Eraser Bipolar 25G, fine tip, straight, 5/SP; Part Number 221267; UDI: 30886158010549
Products were packaged with incorrect labeling,
Apheresis Red Blood Cells, Leukocytes Reduced
Apheresis product, which was irradiated labeled with an incorrect expiration date, was distributed.
Product distributed to retail stores and distributors in Alabama, Arkansas, Florida, Maine, Missouri, Nebraska, Nevada, New Mexico, New York, Ohio, Oklahoma, Texas, Utah, Washington and Wyoming.
Budget $aver Sugar Free Twin Pops Net Contents 28.2 FL OZ
The Colorado Department of Public Health & Environment notified the firm that they had recovered Listeria monocytogenes from multiple environmental sampling sites collected during an inspection at their Denver plant.
Budget $aver Monster Cherry-Pineapple Pops Net Contents 36 FL OZ
Munk Pack PROTEIN COOKIE DOUBLE DARK CHOCOLATE NET WT 2.96oz (84g); UPC: 853787005368
1774 master cases (total for all products)
Munk Pack PROTEIN COOKIE PEANUT BUTTER CHOCLATE CHIP NET WT 2.96oz (84g); UPC: 853787005351
US Nationwide Distribution in the states of: AR, AZ, CA, FL, GA, IL, IN, LA, MA, MI, MO, MS, NC, ND, NH, NJ, NV, NY, OH, PA, SC, TN, TX, VA, WA, WI, WV, and Puerto Rico.
(Item 829155)    Product Usage:  INTENDED FOR INJECTION OF U100 INSULIN ONLY
The retail shelf cartons may be labeled with an incorrect lot number.
(Item 829555)    Product Usage:  INTENDED FOR INJECTION OF U100 INSULIN ONLY
Eden's Ethnos Bulk Kratom  25 powder kilogram bag  Also called K. Bali Supreme, K Maeng Da Supreme, K Green Vein, Green Maeng Da, K Red Maeng Da, K Red Bali, K Green Bali    Distributed by Eden Ethnos LLC, Carlsbad, CA 92010
FDA and state samples found Salmonella in Kratom products that traced back to Eden Ethnos LLC.
Distributed nationwide throughout the US and the following countries - Vietnam,   Dom Republic, Kuwait, Panama, Saudi, Korea, Germany, Iceland, EU, Bermuda, Australia, Jordan
Lean Pro 8 Chocolate 2,268g (5lb) Tub and Lean Pro 8 Chocolate 1,000g (2.2lb) Tub
Lean Pro 8 Cookies & Cream 1,000g (2.2lb) Tub
FL, AR, OR, UT, PA, CA, NJ, MA,NY, MD, IL, IN,SC, TN, LA, GA.
Sugarfina Platinum Bling Ring;  Product SKU No. R-1790  UPC: 840278116139  Net W. 21g ().7 oz.)    Sculpted from dark chocolate, these interlocking rings have a thin sugar shell brushed with edible silver:    Ingredients: Dark Chocolate (cocoa, sugar, cocoa butter, soy lecithin (an emulsifier_ sugar, Dextrose, gum Arabic, color added, gelatin.    Made in Greece  Distributed by Sugarfina Inc.  Santa Monica Blvd., Beverly Hills, CA
Internal audit discovered that their Platinum Bling Ring product contains fish gelatin that is not declared on the ingredient or allergen information
Pea Shoots Microgreens, Greenbelt Microgreens brand, net wt. 75 gram.  Product is packaged in a clear plastic clam shell container. UPC 8 90082 00023 0
Pea Shoots Microgreens product is recalled due to a potential to be contaminated with Listeria monocytogenes.
Fresh Microgreen Mix, Greenbelt Microgreens brand, net wt. 75 gram. Product is packaged in a clear plastic clam shell container.  UPC 8 90082 00041 4
Fresh Microgreen Mix product is recalled due to a potential to be contaminated with Listeria monocytogenes.
Sweet & Crunchy Microgreen Mix, Greenbelt Microgreens brand, net wt. 75 gram.  Product is packaged in a clear plastic clam shell container. UPC 8 90082 00006 3
Sweet & Crunchy Microgreen Mix product is recalled due to a potential to be contaminated with Listeria monocytogenes.
Spicy Microgreen Mix, Greenbelt Microgreens brand, net wt. 75 gram.  Product is packaged in a clear plastic clam shell container. UPC 8 90082 00000 1
Spicy Microgreen Mix product is recalled due to a potential to be contaminated with Listeria monocytogenes.
Broccoli Microgreens, Greenbelt Microgreens brand, net wt. 75 gram.  Product is packaged in a clear plastic clam shell container. UPC 8 90082 00016 2
Broccoli Microgreens product is recalled due to a potential to be contaminated with Listeria monocytogenes.
Sunflower Microgreens, Greenbelt Microgreens brand, net wt. 75 gram.  Product is packaged in a clear plastic clam shell container. UPC 8 90082 00030 8
Sunflower Microgreens product is recalled due to a potential to be contaminated with Listeria monocytogenes.
Arugula Microgreens, Greenbelt Microgreens brand, net wt. 75 gram.  Product is packaged in a clear plastic clam shell container. UPC 8 90082 00012 4
Arugula Microgreens product is recalled due to a potential to be contaminated with Listeria monocytogenes.
US Distribution to the states of : California and Georgia
70 Seeds at 0.28mCi and 100 seeds at 0.36mCi
OraVerse (Phentolamine Mesylate) Injection,  0.4 mg/1.7mL, packaged in a box of 10 cartridges of 0.4mg/1.7mL each, Rx only, Distributed by Septodont, Inc., Louisville, CO 80027, Made in Canada by Novocol Pharmaceutical of Canada, Inc., NDC 0362-0101-10
Failed Impurities/Degradation: This recall has been initiated due to an out of specification (OOS) result that was obtained for related substance (Phentolamide), a known degradation product impurity at the 15 month stability test point.
Metoprolol Succinate Extended-Release Tablets, USP, 100 mg, 100 Tablets bottle, Rx only, Manufactured by: Dr. Reddy's Laboratories Limited Bachupally-500 090 India\  NDC 55111-468-01
Presence of Foreign Tablets/Capsules: One foreign tablet identified as Clopidogrel 75 mg was found in a 100 count bottle of Metoprolol Succiante Extended-Release Tablets.
worldwide Distribution - US Distribution to the states of : CA, FL, MO, NC, SC, TX, and WI., and to the countries of :  Argentina, China, Colombia, Germany, Japan, Netherlands, South Africa, Thailand, and Vietnam.
Lactosorb RapidFlap, bone plate, Model No. 915-0020    The RapidFlap LS Cranial Fixation System is indicated for use in pediatric craniotomy flap fixation.
The recalling firm has confirmed that the Outer Plate component exhibits an excessive chamfer on the threading after deburring operations. This excessive chamfer results in non-conforming product where the threads of the outer plate component have limited to no engagement with the post component.
Ampicillin and Sulbactam for Injection, USP, 3 gram*s/vial, packaged in 10-count vials per carton, Rx only, Distributed by: AuroMedics Pharma LLC, 279 Princeton-Hightstown Rd., E. Windsor, NJ  08520, NDC 55150-117-20.
Presence of Particulate Matter: confirmed customer report of the presence of visible particulate matter believed to be red rubber particles from the manufacturing process of the active ingredients.
AK, AR, AZ, CA, CO, CT, FL, IL, MA, MN, MO, NC, NH, NJ, NY, PA, TX, VT, WA, WI, WY
STONEWALL KITCHEN Basil Pesto Aioli Net Weight Net 10.25 oz. UPC: 7 11381 03060 8. Product is incorrectly labeled as Basil Pesto, Net Weight 8 oz.
Product Distributed thru our the nation.
Asian Best, Tamarind Candy   Net Weight: 4 oz.  Units Per Carton: 72 units
Eastland Food Corporation out an abundance of caution has decided to initiate a product recall of  all Asian Best, Tamarind Candy ( UPC: 083737158008 ) and  Tamarind Candy Hot Flavor ( UPC: 083737158022 ) due to   elevated levels of lead (0.15 ppm) when compared against FDA s action level of 0.1 ppm.
Asian Best, Tamarind Candy Hot Flavor   Net Weight: 4 oz.  Units Per Carton: 72 units
Macroaggregated albumin (MAA) kit (for the preparation of Tc99m MAA), Aggregated and non-Aggregated Human Serum Albumin 2.5-5 mg Sodium Acetate Sol 200 mL/0.125 mL lyophilized powder in 10 mL glass vial, Rx only, AnazaoHealth, Tampa, FL
Distributed in CA, IL, FL, MI, NH, NJ, NY, OR, and TX.
100% Whole Wheat Bread Mix is recalled due to undeclared wheat in  the label on the back side of the package.
Best by 16 JUL 2019.   249490  05:24 14 01 2018     (05:24 stands for production time and 14 01 2018 stands for production date of January 14, 2018)
Recalling Red Suma, Green Suma, Red Hulu 2, Green Hulu 2 Kratom products due to potential salmonella.
Everything manufactured between 1/1/18 to 4/12/18.
Acadica Kratom:   Green Hulu 2 Kratom, 250g bags
Blood products collected from a donor whose arm cleansing procedures were performed using an expired cleanser, were distributed.
Minivelle (estradiol transdermal system) 0.0375 mg/day, packaged in 8-systems per box, Rx only, Mfd. by: Noven Pharmaceuticals, Inc. Miami, Florida 33186 Dist. by: Noven Therapeutics, LLC Miami, Florida 33186, NDC 68968-6637-8
Defective Delivery System: Product is out of specification for shear
Minivelle (estradiol transdermal system) 0.1 mg/day, packaged in 8-systems per box, Rx only, Mfd. by: Noven Pharmaceuticals, Inc. Miami, Florida 33186 Dist. by: Noven Therapeutics, LLC Miami, Florida 33186, NDC 68968-6610-8
Soozie s Doozies Sugar Cinnamon Snickerdoodle Cookie Dough, 16 ounce, plastic pouch, 6 pouches per case
National Foodworks Services is voluntarily recalling Soozie s Doozies Sugar Cinnamon Snickerdoodle Cookie Dough due to contamination with Staphylococcus aureus.