USA: MI  FL  CA  TX    India, Russia, Puerto Rico, N. Mariana Island/Palau.
EasyCAL HbA1c Calibrator; REF 10658  Kit is packaged in a paper box containing 4 vials of 0.25ml of calibrant, one for each calibration level, and an insert sheet.
Patient results determined using this calibrator lot might deviate up to 20%. Controls might not indicate false values.
Worldwide distribution  US nationwide, Canada, Chile, Costa Rica, Denmark, France, Hungary, Italy, Japan, Lebanon, Portugal, Serbia, Spain, and Taiwan.
Tapered Screw-Vent MTX, Dental Implant, sterile.  Model TSVTB10.
Two lots of the Tapered Screw-Vent Implants, with different outer thread diameters, were inadvertently commingled during the manufacturing process and may be mislabeled.
Tapered Screw-Vent MTX, Dental Implant, sterile.  Model TSV4B10.
Lithium Heparin Plasma Blood Collection Tubes for Invitro Diagnostic Use, Catalog Numbers: 365043, 365044, 365045 & 365047      Used to collect, separate, process, transport and store venous blood samples for use in chemistry determinations, therapeutic drug monitoring and zinc testing in plasma for in vitro diagnostic use.
Increased amount of residual blood present on the top of stopper well after venipuncture
c6000, Chemistry (Photometric, Discrete), for clinical use. - cobas e 601 module: Immunoassay Analyzer, Catalog Numbers: 04745922001, 05036348001, 05860652001, 04745922692, 05036348001 & 05036348692
Complaints have been received concerning questionable results on analyzers due to customers utilizing 13 sample tubes without tube adapters.
cobas e 411 Immunoassay Analyzer (Discrete Photometric Analyzer for  Clinical use), Catalog Numbers: 04775201001 (rack system), 04775279001 (disk system), 04775201973 (rack system) & 04775279973 (disk system).
Complaints have been received concerning questionable results on analyzers due to customers utilizing 13 mm sample tubes without tube adapters.
Modular E 170 Analyzer: Immunoassay Chemistry Analyzer, Chemistry  (Photometric, Discrete) for clinical use, Catalog Numbers: 03739040692,  03023109001, 05023599001, 05023572001, 03739040001 & 03023109973.
Complaints have been received concerning questionable results on analyzers due to customers utilizing sample 13 mm tubes without tube adapters.
Worldwide distribution.  US nationwide including Puerto Rico,   Korea, Czech Republic, China, Japan, Great Britain, Austria, Malaysia, Hong Kong, Russia, Taiwan, Singapore, India, and Brazil
ACUVUE ADVANCE Brand Contact Lenses with HYDRACLEAR
Some contact lenses were associated with complaints of a foreign matter caught between the blister package and foil.
Lot B00DHLP Exp. 08/2018 Base Curve 8.7, Refractive Power -10.00D - Manufactured in J&J Vision Care Inc. Jacksonville, FL  Lot L002FNL Exp. 07/2020 Base Curve 8.7 Refractive Power -4.75D Manufactured in J&J Vision Care Ireland  Lot L002V94 Exp. 01/2022 Base Curve 8.7 Refractive Power -5.00D
ACUVUE OASYS Brand Contact Lenses with HYDRACLEAR PLUS
Lot L002NCS exp. 05/2020 base Curve 8.8 Refractive Power -4.00D and Lot L002QH9 exp. 08/2020 Base Curve 8.8 Refractive Power -4.50D Manufactured at J&J Vision Care Ireland
1-DAY ACUVUE Moist for ASTIGMATISM Brand Contact Lenses
Lot B00LF41 Exp. 04/2021 Base Curve 8.5 Refractive Power -7.50D -1.25/180 Manufactured at J&J Vision Care Inc. Jacksonville, FL
Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 54mm, REF 804-07-540        Product Usage:  The AltiVate Anatomic Shoulder System is a total shoulder system indicated as an anatomic shoulder joint replacement for patients suffering from pain and dysfunction.
It was discovered during a surgery that the design of the radius at the base of the pegs of the Anatomic Glenoid Trial (Part Numbers: 804-07-380, 804-07-420, 804-07-460, 804-07-500, and 804-07-540) is much larger on the trails than on the implants
Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 46mm, REF 804-07-460    Product Usage:  The AltiVate Anatomic Shoulder System is a total shoulder system indicated as an anatomic shoulder joint replacement for patients suffering from pain and dysfunction.
Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 50mm, REF 804-07-500    Product Usage:  The AltiVate Anatomic Shoulder System is a total shoulder system indicated as an anatomic shoulder joint replacement for patients suffering from pain and dysfunction.
Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 38mm, REF 804-07-380    Product Usage:  The AltiVate Anatomic Shoulder System is a total shoulder system indicated as an anatomic shoulder joint replacement for patients suffering from pain and dysfunction.
Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 42mm, REF 804-07-420    Product Usage:  The AltiVate Anatomic Shoulder System is a total shoulder system indicated as an anatomic shoulder joint replacement for patients suffering from pain and dysfunction.
Sofia 2 Analyzer Catalog Number 20299      Sofia 2 is a bench top analyzer intended to be used with Cassette-based immunofluorescent in vitro diagnostic assays . Sofia 2 is intended for professional and laboratory use.
The calibration for the affected batch of analyzers was incorrectly set during the manufacturing process which may lead to a failure when calibration is first performed. There may also be e remote possibility that incorrect qualitative test results for patient samples near the assay cutoff may be reported.
International Distribution to: Germany only.
A locking plastic abutment sleeve, used by dental technicians in dental laboratories to aid in the creation of the final restorative crown, was packed as a non-locking plastic abutment sleeve.
Teleflex MEDICAL WECK Visistat 35.  Used for the external skin closure of lacerations.
Some boxes are labeled as Visistat Wide devices, when in fact the contain Visistat Regular devices.  The 6 individually packaged units within the boxes are correctly labeled.
Flucanazole Injection, USP 200 mg in in 100 mL (2 mg/mL), 10 Single Dose Flexible Containers, Rx Only, Manufactured for: Claris Lifesciences, Inc. North Brunswick, NJ 08902 By; Claris Injectables Ltd. Gujarat, India --- NDC 36000-006-10
Superpotent and Failed Stability Specifications; out of specification results for assay and water vapor permeability
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Coconut is listed in the ingredient statement but is not declared in the Contains statement
VP6 47 through VP6 53 (Fresh Case)  W VP6 47 through W VP6 53 (Grab and Go)
(Grab and Go) W-HC47 through WHC53;   (Fresh Case) HC47 through HC53
Evamist (estradiol transdermal spray), 1.53mg estradiol/spray, 0.27 fl oz (8.1 mL) per bottle, Rx Only, Manufactured for Perrigo, Minneapolis, MN 55427.  NDC: 0574-2067-27
Defective Delivery System: Potential that cracks in the vial neck near the crimp may result in product evaporation and/or leaking and the inability to properly dispense product.
Stryker Instruments Div. of Stryker Corporation
The Stryker Thoracic Pedicle Feeler 6002-350-000 is a smart instrument for remote control of  the navigation software and creation of a pathway into the pedicle. The instrument has three  types of buttons to remotely control the software: the UP, DOWN and SELECT buttons. The  Pedicle Feeler is laser marked in 10 mm intervals to help indicate the depth in which the feeler  tip has been inserted into the pedicle. Next to the navigational information, these depth  indicators on the feeler tip are also helpful in determining the appropriate pedicle screw length.
Worldwide Distribution: US (Nationwide) and countries of: New Zealand, Saudi Arabia, Switzerland, United Arab Emirates Uruguay & Republic of Macedonia (The former Yugoslav Republic of Macedonia).
Wire sets of certain devices were assembled with adhesive on the contact wires, which may impede conductivity and could cause failure
Connector, REF/Catalog Number 2602M     Indicated for use in external pacing, defibrillation and monitoring applications as a non-sterile, disposable device for single pediatric use, only. The PadPro 2602 electrodes provide the conductive interface between the defibrillator and/or the external transcutaneous (non-invasive) cardiac pacemaker and the pediatric patients skin. The electrode is intended for use on pediatric infants whose weight is less than 10 kg. (22 lbs.).
MINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, Philips Plug Style Connector, REF/Catalog Number 2602H     Indicated for use in external pacing, defibrillation and monitoring applications as a non-sterile, disposable device for single pediatric use, only. The PadPro 2602 electrodes provide the conductive interface between the defibrillator and/or the external transcutaneous (non-invasive) cardiac pacemaker and the pediatric patients skin. The electrode is intended for use on pediatric infants whose weight is less than 10 kg. (22 lbs.).
MINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, Universal/Anderson Connector, REF/Catalog Number 2602    Indicated for use in external pacing, defibrillation and monitoring applications as a non-sterile, disposable device for single pediatric use, only. The PadPro 2602 electrodes provide the conductive interface between the defibrillator and/or the external transcutaneous (non-invasive) cardiac pacemaker and the pediatric patients skin. The electrode is intended for use on pediatric infants whose weight is less than 10 kg. (22 lbs.).
AltiVate Reverse INSTRUMENTATION, HUMERAL SOCKET SHELL TRIAL, STANDARD, REF 804-06-152, Qty: 01, Encore Medical, LP  Orthopedic surgical instrument.    Product Usage:  The humeral socket shell trial is used to replicate/trial the shell geometry of the AltiVate Reverse Standard Shell Humeral Stem implants. It assembles to the humeral broaches by a screw in order to replicate/trial the entire humeral stem implant geometry prior to implantation.
Broken or missing screws and retaining clips.  This may be due to screw tolerance and material strength of the trial.
US, Canada, China, Sweden, Germany, Japan, Qatar, France, Audtralia
IMRIS ORT200 Removable Operating Room Table, 50-60 Hz Version is intended for use during diagnostic examinations or surgical procedures to support and position a patient.
The rotational locking mechanisms on the ORT 200/300 tables fail to operate such that it cannot change states between locked and unlocked.
IMRIS ORT300 Removable Operating Room Table, 50-60 Hz Version is intended for use during diagnostic examinations or surgical procedures to support and position a patient.
Worldwide Distribution - USA (nationwide) Distribution to the states of :  AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV, WY, and the District of Columbia.  and to the countries of : Argentina, Chile, Mexico, Panama, Canada, Australia, New Zealand, Austria, Bahrain, Belgium, Bulgaria, Croatia, Czech Republic, Egypt, Estonia, France, Germany, Greece, Hungary, Ireland, Italy, Jordan, Kuwait, Latvia, Lebanon, Lithuania, Morocco, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Turkey, United Arab Emirates, United Kingdom, Israel, Netherlands, Tunisia, Brunei, Indonesia, Malaysia, Myanmar, Philippines, Singapore, Thailand, and Vietnam
Rechargeable Li-ion battery used with Puritan Bennett TM 980 Series Ventilator System including Pediatric-Adult Ventilator, Neonatal Ventilator, Universal Ventilator; Battery Product Number: 10086042; UDI: 20884521700861    The rechargeable lithium-ion batteries are intended to provide a backup power source to the ventilator in case AC power is lost.
Rechargeable lithium-ion batteries with incorrect firmware that are used in certain Puritan Bennett 980 ventilators may not fully charge after installation.
Mesa Laboratories Bozeman Manufacturing Facility
United States, Republic of Korea, Israel, Poland, France, China, Canada, Japan, Singapore, Hong Kong, Jordan
ProSpore Biological Indicator Part Numbers: PS-6-50, PS-5-50, PS-4-10, PS-4-50, 3471
The concentration of bromocresol purple in the recalled lots does not conform to specification.
SporAmpule Biological Indicator Catalog Number SPS5-100
Worldwide distribution.  Austria, Denmark, Germany, Singapore, Netherlands, Hong Kong, and Switzerland.  US product is not affected.
Nucleic Acid test intended for screening for MRSA/SA.  Each kit has 20 tubes.  in vitro diagnostic.
The cobas MRSA/SA tests may have decreased performance compared to the analytical sensitivity for MSRA detection.  A screening failure can lead to potential infection in the colonized patient being tested as well as the spread of MSRA to others.  The United States is not impacted, as the cobas MRSA/SA nucleic acid test for use on the cobas liat system is not available in the US.
Lot #s: 70712A (6 kits); 70601W (76 kits); 70713A (4 kits); 70718A (50 kits); and 70809A (kits were not distributed to end users).
Worldwide Distribution: US (nationwide) including states of: AL, CA, FL, GA, IL, IN, MN, OR, TN, TX, VA, and WA; and countries of: Argentina, Austria, Belgium, Brazil, Canada, France, Germany, India, Iraq, Israel, Italy, Japan, Lebanon, Malaysia, Mexico, Namibia, Pakistan, Peru, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, Spain, South Africa, Switzerland, Taiwan, and United Arab Emirates.
The FEMTO LDV(TM)Z8 Femtosecond Surgical Laser      The FEMTO LDV(TM)Z8 Femtosecond Surgical Laser is an ophthalmic surgical laser intended for use in the creation of corneal incisions indicated for use in patients undergoing LASIK surgery, tunnel creation for implantation of rings, pocket creation for implantation of corneal implants, lamellar keratoplasty, penetrating keratoplasty or other treatment requiring lamellar resection of the cornea at a varying depth with respect to the corneal surface. In addition, the FEMTO LDV(TM)Z8 Surgical Laser is intended for use in the creation of capsulotomy, phacofragmentation and the creation of single plane, multi-plane, arc cuts/incisions in the cornea, each of which may be performed either individually or consecutively during the same procedure indicated for use in patients undergoing cataract surgery for removal of the crystalline lens.
This Correction is being initiated based on a customer complaint received on November 16, 2017 which indicated a complication with a cataract procedure.  An investigation completed by the manufacturer determined that although the complication was due to user error improvements could and should be made on our part to improve the usability and performance of our device.
There was no U.S. distribution.  Distribution was made to Panama and United Kingdom.
QUANTA-Lyser 240 EIA, Part #GS0241.    The instrument is a fully automated, high-throughput, bench top system designed for clinical use to automate slide and reagent barcode reading, sample dilution and distribution, reagent pipetting and dispensing, slide and plate washing, dispensing slide mounting medium in the preparation for microscope analysis, and photometric measurement of microwell plates.
The device power supply was not manufactured according to specification which can result in the loss of the protective grounding of the instrument.
QUANTA-Lyser 240 IFA, Part #GS0242.    The instrument is a fully automated, high-throughput, bench top system designed for clinical use to automate slide and reagent barcode reading, sample dilution and distribution, reagent pipetting and dispensing, slide and plate washing, dispensing slide mounting medium in the preparation for microscope analysis, and photometric measurement of microwell plates.
USA (nationwide) Distribution to the states of : AL, AR, AZ, CA, CO, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, NJ, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI., and Internationally to Japan and Netherlands.
Persona Partial Knee spacer block instruments; (1) 8mm block, Model Number: 42-5399-035-08; (2) 9mm block, Model Number:42-5399-035-09; (3) 10mm block, Model Number: 42-5399-035-10; (4) 12mm block, Model Number: 42-5399-035-12; (5) 14mm block, Model Number: 42-5399-035-14  A spacer block is used to ensure the tibial resection Is sufficient and to verify limb alignment. After verification the distal femoral resecUon Is complete using the distal femoral cut slot in the spacer block. The spacer block determines how much distal femoral bone is resected.
Certain partial knee implant spacer blocks do not fit in the alignment tower instrument or handle.
indicated for patients with severe knee pain and disability due to: - Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.
A complaint was received for Item 42-5320-067-02, lot 63236047. It was report that there was no set screw or taper plug included in the box. Complaint investigation confirmed that the entire lot of 63236047 was missing the set screw and taper plug.
Persona Partial Knee Spacer Blocks    To assist in partial knee arthroplasty surgery
Zimmer Biomet is conducting a medical device recall for the Persona Partial Knee Spacer Blocks in sizes 8mm, 9mm, 10mm, 12mm, and 14mm. Complaints received indicated that flexion has the potential to feel  tight  during range-of-motion trialing and that the final trial has the potential to appear looser in extension.
Comprehensive Segmental Revision System (SRS)
Zimmer Biomet received reports that during assembly, an SRS Humeral Distal Body implant failed to engage correctly at the point of reduction with a Discovery Elbow System Humeral Condyle. A mismatch occurred between the screw holes in the Distal Humeral Body & the Discovery Elbow Condyle implant during vendor machine operation. The condition would be noticed during assembly and therefore, if the product has already been implanted, no further action is required. The mismatch does not always prevent engagement of the screw, based on complaints received it is estimated to prevent engagement of the screw in less than 1% of cases.
Coonrad/Morrey Elbow Implant System humeral assembly 4IN XSML, Item Number: 32-8105-027-04 (UDI: (01)0088902427 4006(17)220731(10)63694912)
One lot of humeral stem implants do not include the humeral bushing components.
Affected lots may have exceeded its microbial limits.
EP-4 Lots EXP20 l 7 l 209A, EXP20 l 80512A; and EP-4D  Lot EXP20 l80520A
Distributed in the following U.S. states: AZ, CA, CT, IN, MD, MI, MN, NJ, NY, OR, WA, and Puerto Rico. Distributed in China and India.
Zimmer M/L Taper Hip Prosthesis, 7711 Series, Femoral Stem 12/14 Neck Taper Plasma Sprayed Press-Fit Cementless Size 4 Standard Reduced Neck Length; Part Number: 00-7711-004-10
Certain packages labeled as size 7.5 Extended Offset Reduced Neck length hip implant, actually contained a Size 4 Standard Reduced Neck length taper hip implant.
Zimmer M/L Taper Hip Prosthesis, 7711 Series, Femoral Stem 12/14 Neck Taper Plasma Sprayed Press-Fit Cementless Size 7.5 Extended Offset Reduced Neck Length; Part Number: 00-7711-007-40
ACE Trochanteric Nail System  STER L H TROC NAIL 320X9X125  STER L H TROC NAIL 340X9X125  STER L H TROC NAIL 360X9X125  STER L H TROC NAIL 380X9X125  STER L H TROC NAIL 400X9X125  STER L H TROC NAIL 420X9X125  STER L H TROC NAIL 440X9X125  STER L H TROC NAIL 460X9X125  STER L H TROC NAIL 320X11X125  STER L H TROC NAIL 340X11X125  STER L H TROC NAIL 360X11X125  STER L H TROC NAIL 380X11X125  STER L H TROC NAIL 400X11X125  STER L H TROC NAIL 420X11X125  STER L H TROC NAIL 440X11X125  STER L H TROC NAIL 460X11X125  STER L H TROC NAIL 320X13X125  STER L H TROC NAIL 340X13X125  STER L H TROC NAIL 360X13X125  STER L H TROC NAIL 380X13X125  STER L H TROC NAIL 400X13X125  STER L H TROC NAIL 420X13X125  STER L H TROC NAIL 440X13X125  STER L H TROC NAIL 460X13X125  STER R H TROC NAIL 320X9X125  STER R H TROC NAIL 340X9X125  STER R H TROC NAIL 360X9X125  STER R H TROC NAIL 380X9X125  STER R H TROC NAIL 400X9X125  STER R H TROC NAIL 420X9X125  STER R H TROC NAIL 440X9X125  STER R H TROC NAIL 460X9X125  STER R H TROC NAIL 320X11X125  STER R H TROC NAIL 340X11X125  STER R H TROC NAIL 360X11X125  STER R H TROC NAIL 380X11X125  STER R H TROC NAIL 400X11X125  STER R H TROC NAIL 420X11X125  STER R H TROC NAIL 440X11X125  STER R H TROC NAIL 460X11X125  STER R H TROC NAIL 320X13X125  STER R H TROC NAIL 340X13X125  STER R H TROC NAIL 360X13X125  STER R H TROC NAIL 380X13X125  STER R H TROC NAIL 400X13X125  STER R H TROC NAIL 420X13X125  STER R H TROC NAIL 440X13X125  STER R H TROC NAIL 460X13X125  STER L H TROC NAIL 320X11X130  STER L H TROC NAIL 320X9X130  STER L H TROC NAIL 340X9X130  STER L H TROC NAIL 360X9X130  STER L H TROC NAIL 380X9X130  STER L H TROC NAIL 400X9X130  STER L H TROC NAIL 420X9X130  STER L H TROC NAIL 440X9X130  STER L H TROC NAIL 460X9X130  STER L H TROC NAIL 340X11X130  STER L H TROC NAIL 360X11X130  STER L H TROC NAIL 380X11X130  STER L H TROC NAIL 400X11X130  STER L H TROC NAIL 420X11X130  STER L H TROC NAIL 440X11X130  STER L H TROC NAIL 460X11X130  STER L H TROC NAIL 320X13X130  STER L H TROC NAIL 340X1
Zimmer Biomet is conducting a medical device recall for the ACE Trochanteric Nail (ATN) system after a Device Performance Review (DPR) failed clinical analysis for survivorship pursuant to the acceptance criteria for the DPR protocol for the ATN system.
ACE Trochanteric Nail System  ATN AR SCREW 60MM STERILE  ATN AR SCREW 65MM STERILE      The Trochanteric Nail System is intended to treat stable and unstable proximal fractures of the femur including pertrochanteric fractures, intertrochanteric fractures, high subtrochanteric fractures and combinations of these fractures. The Trochanteric Long Nail System is additionally indicated to treat pertrochanteric fractures associated with shaft fractures, pathologic fractures in osteoporotic bone of the trochanteric and diaphyseal areas, long subtrochanteric fractures, ipsilateral femoral fractures, proximal or distal nonunions and malunions and revision procedures.
ACE Trochanteric Nail System  ATN LAG SCREW 60MM STERILE  ATN LAG SCREW 65MM STERILE  ATN LAG SCREW 70MM STERILE  ATN LAG SCREW 75MM STERILE  ATN LAG SCREW 80MM STERILE  ATN LAG SCREW 85MM STERILE  ATN LAG SCREW 90MM STERILE  ATN LAG SCREW 95MM STERILE  ATN LAG SCREW 100MM STERILE  ATN LAG SCREW 105MM STERILE  ATN LAG SCREW 110MM STERILE  ATN LAG SCREW 115MM STERILE  ATN LAG SCREW 120MM STERILE  ATN LAG SCREW 125MM STERILE  ATN LAG SCREW 130MM STERILE        The Trochanteric Nail System is intended to treat stable and unstable proximal fractures of the femur including pertrochanteric fractures, intertrochanteric fractures, high subtrochanteric fractures and combinations of these fractures. The Trochanteric Long Nail System is additionally indicated to treat pertrochanteric fractures associated with shaft fractures, pathologic fractures in osteoporotic bone of the trochanteric and diaphyseal areas, long subtrochanteric fractures, ipsilateral femoral fractures, proximal or distal nonunions and malunions and revision procedures.
ACE Trochanteric Nail System  STER TROC LAG SCR 70 MM    The Trochanteric Nail System is intended to treat stable and unstable proximal fractures of the femur including pertrochanteric fractures, intertrochanteric fractures, high subtrochanteric fractures and combinations of these fractures. The Trochanteric Long Nail System is additionally indicated to treat pertrochanteric fractures associated with shaft fractures, pathologic fractures in osteoporotic bone of the trochanteric and diaphyseal areas, long subtrochanteric fractures, ipsilateral femoral fractures, proximal or distal nonunions and malunions and revision procedures.
ACE Trochanteric Nail System  STER TROC NAIL 125 DEG X 9MM  STER TROC NAIL 130 DEG X 9MM  STER TROC NAIL 135 DEG X 9MM    The Trochanteric Nail System is intended to treat stable and unstable proximal fractures of the femur including pertrochanteric fractures, intertrochanteric fractures, high subtrochanteric fractures and combinations of these fractures. The Trochanteric Long Nail System is additionally indicated to treat pertrochanteric fractures associated with shaft fractures, pathologic fractures in osteoporotic bone of the trochanteric and diaphyseal areas, long subtrochanteric fractures, ipsilateral femoral fractures, proximal or distal nonunions and malunions and revision procedures.
ACE Trochanteric Nail System  STER TROC END CAP  STER TROC END CAP 5MM  STER TROC END CAP 10MM  STER TROC END CAP 15MM  STER TROC END CAP 20MM  STER TROC END CAP 25MM    The Trochanteric Nail System is intended to treat stable and unstable proximal fractures of the femur including pertrochanteric fractures, intertrochanteric fractures, high subtrochanteric fractures and combinations of these fractures. The Trochanteric Long Nail System is additionally indicated to treat pertrochanteric fractures associated with shaft fractures, pathologic fractures in osteoporotic bone of the trochanteric and diaphyseal areas, long subtrochanteric fractures, ipsilateral femoral fractures, proximal or distal nonunions and malunions and revision procedures.
ACE Trochanteric Nail System  ACE TROCH NAIL 125 DEG. X 11MM  ACE TROCH NAIL 130 DEG. X 11MM  ACE TROCH NAIL 135 DEG. X 11MM  ACE TROCH NAIL 125 DEG. X 13MM  ACE TROCH NAIL 130 DEG. X 13MM  ACE TROCH NAIL 135 DEG. X 13MM    The Trochanteric Nail System is intended to treat stable and unstable proximal fractures of the femur including pertrochanteric fractures, intertrochanteric fractures, high subtrochanteric fractures and combinations of these fractures. The Trochanteric Long Nail System is additionally indicated to treat pertrochanteric fractures associated with shaft fractures, pathologic fractures in osteoporotic bone of the trochanteric and diaphyseal areas, long subtrochanteric fractures, ipsilateral femoral fractures, proximal or distal nonunions and malunions and revision procedures.
ACE Trochanteric Nail System  STER TROC NAIL 180X11X140  STER TROC NAIL 125 DEG X 11MM  STER TROC NAIL 130 DEG X 11MM  STER TROC NAIL 135 DEG X 11MM    The Trochanteric Nail System is intended to treat stable and unstable proximal fractures of the femur including pertrochanteric fractures, intertrochanteric fractures, high subtrochanteric fractures and combinations of these fractures. The Trochanteric Long Nail System is additionally indicated to treat pertrochanteric fractures associated with shaft fractures, pathologic fractures in osteoporotic bone of the trochanteric and diaphyseal areas, long subtrochanteric fractures, ipsilateral femoral fractures, proximal or distal nonunions and malunions and revision procedures.
ACE Trochanteric Nail System  STER TROC NAIL 180X13X140  STER TROC NAIL 125 DEG X 13MM  STER TROC NAIL 130 DEG X 13MM  STER TROC NAIL 135 DEG X 13MM        The Trochanteric Nail System is intended to treat stable and unstable proximal fractures of the femur including pertrochanteric fractures, intertrochanteric fractures, high subtrochanteric fractures and combinations of these fractures. The Trochanteric Long Nail System is additionally indicated to treat pertrochanteric fractures associated with shaft fractures, pathologic fractures in osteoporotic bone of the trochanteric and diaphyseal areas, long subtrochanteric fractures, ipsilateral femoral fractures, proximal or distal nonunions and malunions and revision procedures.
ACE Trochanteric Nail System  TROCH NAIL ST 13X180 125DG STRL  TROCH NAIL ST 13X180 130DG STRL  TROCH NAIL ST 13X180 135DG STRL    The Trochanteric Nail System is intended to treat stable and unstable proximal fractures of the femur including pertrochanteric fractures, intertrochanteric fractures, high subtrochanteric fractures and combinations of these fractures. The Trochanteric Long Nail System is additionally indicated to treat pertrochanteric fractures associated with shaft fractures, pathologic fractures in osteoporotic bone of the trochanteric and diaphyseal areas, long subtrochanteric fractures, ipsilateral femoral fractures, proximal or distal nonunions and malunions and revision procedures.
ACE Trochanteric Nail System  TROCH NAIL ST 11X180 125DG STRL  TROCH NAIL ST 11X180 130DG STRL  TROCH NAIL ST 11X180 135DG STRL    The Trochanteric Nail System is intended to treat stable and unstable proximal fractures of the femur including pertrochanteric fractures, intertrochanteric fractures, high subtrochanteric fractures and combinations of these fractures. The Trochanteric Long Nail System is additionally indicated to treat pertrochanteric fractures associated with shaft fractures, pathologic fractures in osteoporotic bone of the trochanteric and diaphyseal areas, long subtrochanteric fractures, ipsilateral femoral fractures, proximal or distal nonunions and malunions and revision procedures.
Worldwide and US of Indiana and country of the Republic of Korea.
AIM Tibial Nails intramedullary fixation rod - NON-STERILE; Item numbers: 810508255	NAIL TIB DYN 08 X 25.5  810508270	NAIL TIB DYN 08 X 27.0  810508285	NAIL TIB DYN 08 X 28.5  810508300	NAIL TIB DYN 08 X 30.0  810508315	NAIL TIB DYN 08 X 31.5  810508330	NAIL TIB DYN 08 X 33.0  810508345	NAIL TIB DYN 08 X 34.5  810508360	NAIL TIB DYN 08 X 36.0  810508375	NAIL TIB DYN 08 X 37.5  810508390	NAIL TIB DYN 08 X 39.0  810508405	NAIL TIB DYN 08 X 40.5  810508420	NAIL TIB DYN 08 X 42.0  810509255	NAIL TIB DYN 09 X 25.5  810509270	NAIL TIB DYN 09 X 27.0  810509285	NAIL TIB DYN 09 X 28.5  810509300	NAIL TIB DYN 09 X 30.0  810509315	NAIL TIB DYN 09 X 31.5  810509330	NAIL TIB DYN 09 X 33.0  810509345	NAIL TIB DYN 09 X 34.5  810509360	NAIL TIB DYN 09 X 36.0  810509375	NAIL TIB DYN 09 X 37.5  810509390	NAIL TIB DYN 09 X 39.0  810509405	NAIL TIB DYN 09 X 40.5  810509420	NAIL TIB DYN 09 X 42.0  810510255	NAIL TIB DYN 10 X 25.5  810510270	NAIL TIB DYN 10 X 27.0  810510285	NAIL TIB DYN 10 X 28.5  810510300	NAIL TIB DYN 10 X 30.0  810510315	NAIL TIB DYN 10 X 31.5  810510330	NAIL TIB DYN 10 X 33.0  810510345	NAIL TIB DYN 10 X 34.5  810510360	NAIL TIB DYN 10 X 36.0  810510375	NAIL TIB DYN 10 X 37.5  810510390	NAIL TIB DYN 10 X 39.0  810510405	NAIL TIB DYN 10 X 40.5  810510420	NAIL TIB DYN 10 X 42.0    Product Usage:  A metal rod which, when inserted into the intramedullary canal of the tibia, acts to immobilize by holding the ends of a fractured bone in position to promote healing. This device is non-sterile and must be sterilized prior to use. It is a single-use device.
The AIM Tibial Nails failed a clinical analysis where the surgical revision rate exceeded the acceptance criteria in the Device Performance Review protocol for the implant system.
AIM Tibial Nails intramedullary fixation rod - STERILE; Item numbers: 800508255	NAIL TIB DYN 08X25.5 - STERILE  800508270	NAIL TIB DYN 08X27.0 - STERILE  800508285	NAIL TIB DYN 08X28.5 - STERILE  800508300	NAIL TIB DYN 08X30.0 - STERILE  800508315	NAIL TIB DYN 08X31.5 - STERILE  800508330	NAIL TIB DYN 08X33.0 - STERILE  800508345	NAIL TIB DYN 08X34.5 - STERILE  800508360	NAIL TIB DYN 08X36.0 - STERILE  800508375	NAIL TIB DYN 08X37.5 - STERILE  800508390	NAIL TIB DYN 08X39.0 - STERILE  800508405	NAIL TIB DYN 08X40.5 - STERILE  800508420	NAIL TIB DYN 08X42.0 - STERILE  800509255	NAIL TIB DYN 09X25.5 - STERILE  800509270	NAIL TIB DYN 09X27.0 - STERILE  800509285	NAIL TIB DYN 09X28.5 - STERILE  800509300	NAIL TIB DYN 09X30.0 - STERILE  800509315	NAIL TIB DYN 09X31.5 - STERILE  800509330	NAIL TIB DYN 09X33.0 - STERILE  800509345	NAIL TIB DYN 09X34.5 - STERILE  800509360	NAIL TIB DYN 09X36.0 - STERILE  800509375	NAIL TIB DYN 09X37.5 - STERILE  800509390	NAIL TIB DYN 09X39.0 - STERILE  800509405	NAIL TIB DYN 09X40.5 - STERILE  800509420	NAIL TIB DYN 09X42.0 - STERILE  800510255	NAIL TIB DYN 10X25.5 - STERILE  800510270	NAIL TIB DYN 10X27.0 - STERILE  800510285	NAIL TIB DYN 10X28.5 - STERILE  800510300	NAIL TIB DYN 10X30.0 - STERILE  800510315	NAIL TIB DYN 10X31.5 - STERILE  800510330	NAIL TIB DYN 10X33.0 - STERILE  800510345	NAIL TIB DYN 10X34.5 - STERILE  800510360	NAIL TIB DYN 10X36.0 - STERILE  800510375	NAIL TIB DYN 10X37.5 - STERILE  800510390	NAIL TIB DYN 10X39.0 - STERILE  800510405	NAIL TIB DYN 10X40.5 - STERILE  800510420	NAIL TIB DYN 10X42.0 - STERILE  800511270	NAIL TIB DYN 11X27.0 - STERILE  800511285	NAIL TIB DYN 11X28.5 - STERILE  800511300	NAIL TIB DYN 11X30.0 - STERILE  800511330	NAIL TIB DYN 11X33.0 - STERILE  800511345	NAIL TIB DYN 11X34.5 - STERILE  800511360	NAIL TIB DYN 11X36.0 - STERILE  800511375	NAIL TIB DYN 11X37.5 - STERILE  800511390	NAIL TIB DYN 11X39.0 - STERILE  800511405	NAIL TIB DYN 11X40.5 - STERILE  800511420	NAIL TIB DYN 11X42.0 - STERILE  800512270	NAIL TIB DYN 12X27.0 - STERILE  8
Worldwide Distribution: US (nationwide) and countries of: Austria, Belgium, Canada, Denmark, France, Germany, Italy, Netherlands, Slovakia, Spain and Switzerland.
Dimension Vista System LOCI 8 CALIBRATOR     The LOCI 8 Calibrator is an in vitro diagnostic product for the calibration of follicle stimulating hormone (FSH), luteinizing hormone (LH), prolactin (PRL), and estradiol (E2) methods on the Dimension Vista System.
An increase in the number of failed calibration events or negative bias with Quality Control (QC) and patient samples when using Dimension Vista LOCI 8 Calibrator lot 7CD076 to calibrate Estradiol (E2) Assay.
distributed in CA, CO, CT, IA, KS, FL, MD, MI, MN, MO, ND, NE, NJ, NV, NY, OR, PA, TX, UT, VA, and WA
***STEVE'S REAL FOOD***RAW FROZEN DOG FOOD***TURKEY CANINE RECIPE***Distributed by: Steve's Real Food, Inc. Aumsville, OR***.
One lot of Raw Frozen Dog Food Turkey Canine Recipe, 5 lb. packages, is recalled due to potential to be contaminated with Salmonella.
Distributed in all 50 U.S. States and the District of Columbia. Distributed in Australia, Argentina, Japan, Canada, Chile, Korea, Spain, France, Italy, Netherlands, and United Kingdom.
Intramedullary Brush Standard O.D. 14 mm, Product Number: 6198-001-514, UDI: (01)4546540255853    for orthopedic use.
Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates.
Revolution 90 Degree Tibial Nozzle, Product Number: 0606-516-000, UDI: (01)4546540911971      for orthopedic use.
PCD Kit: Long 90, 13g Match-Ground w/ Bevel, Product Number: 0506-485-000, UDI: (01)4546540907035  for spinal orthopedic use.
180-Gram Cement Cartridge with Breakaway Femoral Nozzle, Product Number: 0206-530-000, UDI: (01)4546540857880      for orthopedic use.
10g/15mm (15/2) iVAS System Kit, Product Number: 0705-115-000, UDI: (01)7613252029830    for spinal orthopedic use.
1. InterPulse Handpiece with coaxial bone cleaning tip, Product Number: 0210-110-100, UDI: (01)4546540861641; 2. InterPulse Handpiece with Coaxial High Flow Tip, Product Number: 0210-114-100, UDI: (01)4546540861764; 3. InterPulse Handpiece with Retractable Coaxial Fan Spray Tip, Product Number: 0210-118-200, UDI: (01)4546540861818; 4. InterPulse Irrigation Only Handpiece with Fan Spray Tip, Product Number: 0210-218-000, UDI: (01)4546540144300      for orthopedic use.
Revolution CMS w/ Femoral Breakaway Nozzle & Med. Press., Product Number: 0606-573-000, UDI: (01)4546540912114      for orthopedic use.
1. AutoPlex System, Product Number: 0605-887-000, UDI: (01)4546540593108; 2. AutoPlex System: w/ VertaPlex HV, Product Number: 0607-687-000, UDI: (01)7613252039259   Bone cement.
1. 11g/10mm iVAS System Kit, Product Number: 0705-310-000, UDI: (01)7613252505983; 2. 11g/15mm iVAS System Kit, Product Number: 0705-315-000, UDI: (01)7613252505969    for spinal orthopedic use.
11g Verteport Cement Cannula (18/pkg), Product Number: 0306-511-000, UDI: (01)7613252594307    for spinal orthopedic use.
1. Femoral Canal Pressurizer without Hub, Medium, Blue, Product Number: 0206-546-000, UDI: (01)4546540039552; 2. Femoral Canal Pressurizer without Hub, Large, Red, Product Number: 0206-547-000, UDI: (01)4546540039569      for orthopedic use.
Break-Away Femoral Nozzle, Product Number: 0206-512-000, UDI: (01)4546540039415      for orthopedic use.
Advanced Cement Mixing (ACM) Kit w/ Femoral Breakaway Nozzle & Prox. Med. Press., Product Number: 0306-573-000, UDI: (01)4546540055415      for orthopedic use.
IDLife Snack Bar Chocolate and Almond (SKU 16-0011)  Organic, non-GMO and gluten-free snack bar. Individually wrapped bars, packaged 10 to a box
IDLife Snack Bars contain almonds but do not declare the presence of peanuts.
IDLife Kids Bar Chocolate and Mixed Berry (SKU 16-0013)  Organic, non-GMO, gluten-free and nut-free snack bar for children. Individually wrapped bars, packaged 10 to a box
IDLife Kids Bar is labeled as nut free. Allergen testing indicated the presence of almonds and coconut.
IDLife Protein Bar Chocolate and Peanut Butter (SKU 16-0012)  Organic, non-GMO and gluten-free protein bar. Individually wrapped bars, packaged 10 to a box
IDLife Protein Bars contain peanuts but do not declare the presence of almonds.
Mindray DS USA, Inc. dba Mindray North America
Worldwide Distribution - U.S. Nationwide in the states: AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WY, including Puerto Rico and distributed to 30 foreign consignees.
Gas Module 3 monitoring spirometer, Part Number: 115-030108-00    Product Usage:  The Gas Module 3 is an accessory device designed to monitor airway gases during anesthesia and/or assisted respiration. Monitored gases includes O2, CO2, N2O and anesthetic agents Halothane, Isoflurane, Sevoflurane, Desflurane and Enflurane. It is intended for use in a fixed location such as the operating room or intensive care unit. The Gas Module 3 is compatible with Mindray patient monitors which display the gas analysis results through the use of a proprietary communication protocol.
The firm made multiple changes to the product requiring the submission of a new 510(k) premarket notification.
All Gas Modules 3 with Part Number 115-030108-00 purchased between February 14, 2008 and October 2015.
The devices have been distributed within the United States and the following countries: United Arab Emirates, Argentina, Austria, Australia, Barbados, Belgium, Bulgaria, Bermuda, Brazil, Canada, Switzerland, Colombia, Costa Rica, Cyprus, Czech Republic, Germany, Denmark, Spain, Finland, Faroe Islands, France, United Kingdom, Guatemala, Hong Kong, Hungary, Indonesia, Ireland, Iceland, Italy, Jamaica, Jordan, Japan, Kenya, South Korea, Kuwait, Lebanon, Latvia, Morocco, Macedonia, Mexico, Netherlands, New Zealand, Oman, Panama, Poland, Portugal, Serbia, Saudi Arabia, Sweden, San Marino, El Salvador, Turkey, Trinidad & Tobago, Ukraine, Uruguay, Venezuela, Virgin Islands, Kosovo, China, and South Africa.
Vital-Port Vascular Access System, Subcutaneous, implanted, intravascular infusion port and catheter, IP, IP-S,     Product usage:  The devices are intended for use in patient therapy requiring long-term vascular access for infusion therapy and/or blood sampling.
Tucker's Pork-Bison Formula, Raw Frozen, Complete & Balanced Formula, Dog Food for all life stages.  2 - 2-1/2 LB Pouches, Net Weight 5 LB (2.268 KG).  UPC code 072635520017. Keep Frozen, Raw Basics, LLC, 10,000 80th Ave., Pleasant Prairie, WI  53158
Product has the potential to be contaminated with Salmonella.
The kit was packaged with the incorrect guidewire. The label indicates the kit contains a marked guidewire. The kits were packaged with an unmarked guidewire.
Lot/Serial/Model/Catalog Numbers/Exp. Date:   Lot # MJKK420;   serial # N/A,   Catalog # MRDP80PLN,   Exp. Date 2022-01-09;   UDI#- 884908110449
Complaints regarding 6F Taiga guide catheter tip detachment and/or tip splitting.
Rotating IV Pole      Rotating IV Pole falls under the category classified as capital equipment, an optional accessory that may be purchased to facilitate attachment and consolidation of patient equipment to one central patient care area. Devices commonly attached to IV poles include IV pumps, feeding pumps, and infusion fluid bags. Products used on: Giraffe OmniBed, Giraffe Warmers, Panda Warmers and Giraffe Incubators and Giraffe Shuttle. The IV pole also can be mounted to the Care Plus Incubator and Panda IWS.
There is the potential for the Rotating IV Pole to fall. A fall could result in an injury to a bystander holding the patient or to the operator.
Model Number(s): 6600-0851-800  Affected lot codes are within LAU13921134 - LAU14720444
Konica Minolta Medical Imaging USA, Inc.
Distributed in the following U.S. states: AL, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KY, LA, MA, MD,  MI, MN, MO, MS, NC, NJ, NM, NV, NY,  OH, OK, OR, PA, SC, TN, TX, UT, WA, WI and the District of Columbia. Distributed in Canada and Brazil.
Sonimage HS1 Ultrasound Kit AC adapter, Product Number: A8WA, UDI: 04560141944534
There is a risk of circuit board breakage within the main housing of the AC Adapter unit. Smoke may be emitted from the AC Adapter as a direct result.
Sonimage HS1 Ultrasound Kit AC adapter, Product Number: 1. A9RP, UDI: 04560141945463; 2. AAEU, UDI: 04560141946385; 3. A9RR, UDI: 04560141945470
Sonimage HS1 Ultrasound Kit AC adapter, Product Number: A7AP, UDI: 04560141940031
Sonimage HS1 Ultrasound Kit AC adapter, Product Number: A8AR, UDI: 04560141941588
Mushroom Condensed Soup, packaged in glass pint Kerr jars, is recalled due to under-processed or the venting schedule was not followed.
Worldwide Distribution - U.S. Nationwide  in the states of: CA, CO, FL, IN, MA, NE, NJ, OH, TN, TX, and WI. and countries of Belarus, Belgium, Brazil, Canada, Chile, China, Egypt, Italy, Japan, Poland, Saudi Arabia, Spain, and United Kingdom.
Certain lots of in vitro fertilization (IVF) products were distributed without completed finished device quality testing with potential adverse events that may include nonviable gametes and/or nonviable embryos.
1. Catalog Number: K-J-SMS-571800, Lot Number: 6802704, Expiration Date: 3/10/2019; 2. Catalog Number: K-JETS-551910-L, Lot Number: NS6360603, Expiration Date: 11/15/2018; 3. Catalog Number: K-JETS-7019-SIVF, Lot Number: 6503675, Expiration Date: 2/2/2019
Echosight Jansen-Anderson Intratubal Transfer Set, Catalog Number: K-J-JITS-572900, Global Product Number: G17946      Product Usage:  Used to place in vitro fertilized (IVF) embryos into the uterine cavity. Intended for one-time use
Lot Number: 7131328, Expiration Date: 7/19/2019
Norm-Ject Tuberkulin Syringe, Catalog Number: K-ATS-1000, Global Product Number: G19871    Product Usage:  Used to place in vitro fertilized (IVF) embryos into the uterine cavity. Intended for one-time use
Marrs Laparoscopic GIFT Catheters, Catalog Number:K-J-MLC-503000, Global Product Number: G18022      Product Usage:  Used to place in vitro fertilized (IVF) embryos into the uterine cavity. Intended for one-time use
Lot Number: 5571684, Expiration Date: 1/12/2018
Nationwide (U.S.): SC, FL, WA, KS, GA, NC, TX, TN, OH, MT, & AL
Maurice's Honey Southern Gold BBQ Sauce; Net Wt. 18 oz. bottles; UPC Code 0 7561654332 6 and  Carolina Gold Honey Sauce; Net Wt. 18 oz. bottle; UPC Code 0 7561654383 8
Approx. 1418 cases (12 bottles/case); approx. 17,016 bottles total
Distributed in the following U.S. states: CO, FL, IL, NC, PA, SC, and TX.
Extended Dwell Peripheral Catheter System, Catalog Numbers: EDC-00820 & EDC-00820-B
Certain lots of peripheral catheter systems may be missing the safety latch, intended to minimize the risk of sharps injuries.
Catalog Number: EDC-00820, Lot: 14X17C0039 (Expires February 2019); Catalog Number: EDC-00820-B, Lot: 13F17F0120 (Expires May 2019)
Worldwide Distribution - USA (nationwide) Distribution including Puerto Rico and to the states of :  AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, and the District of Columbia., and to the countries of :  Australia, Austria, Belgium, Canada, Croatia, Denmark, Finland, France, Germany, India, Ireland, Italy, Korea, Luxembourg, Malaysia, Netherlands, Portugal, Singapore, Slovakia. Slovenia, South Africa, Spain, Sweden, Switzerland, Thailand, Turkey, and United Kingdom.
(1) Sigma HP Cemented Trochlea Size 1 Narrow Left, Catalog Number: 102403100, GTIN: 10603295001614; (2) Sigma HP Cemented Trochlea Size 2 Narrow Left, Catalog Number: 102403200, GTIN: 10603295001621; (3) Sigma HP Cemented Trochlea Size 3 Narrow Left, Catalog Number: 102403300, GTIN: 10603295001638; (4) Sigma HP Cemented Trochlea Size 4 Narrow Left, Catalog Number: 102403400, GTIN: 10603295001645; (5) Sigma HP Cemented Trochlea Size 5 Narrow Left, Catalog Number: 102403500, GTIN: 10603295001652; (6) Sigma HP Cemented Trochlea Size 1 Narrow Right, Catalog Number: 102404100, GTIN: 10603295001669; (7) Sigma HP Cemented Trochlea Size 2 Narrow Right, Catalog Number: 102404200, GTIN: 10603295001676; (8) Sigma HP Cemented Trochlea Size 3 Narrow Right, Catalog Number: 102404300, GTIN: 10603295001683; (9) Sigma HP Cemented Trochlea Size 4 Narrow Right, Catalog Number: 102404400, GTIN: 10603295001690; (10) Sigma HP Cemented Trochlea Size 5 Narrow Right, Catalog Number: 102404500, GTIN: 10603295001706
Product was distributed online via eBay.
Red Zone Xtreme 3000 mg, capsules, Dietary Supplement, 1 count blister pack, UPC 8 91656 00200 9, Exp Date 12/31/2021
Marketed without an Approved NDA/ANDA; FDA analysis found this product to contain undeclared Tadalafil, an FDA approved drug for the treatment of erectile dysfunction.
Product was distributed throughout the United States, Hong Kong and New Zealand.
E-Z-Paste Barium Sulfate Esophageal Cream (60% w/w),  454 g tube, Rx only, Manufactured by E-Z-EM Canada Inc. for E-Z-EM Inc. a subsidiary of Bracco Diagnostics Inc., Monroe Twp., NJ 0883, NDC 32909-770-01
Failed stability specifications: Out-of-specification (OOS) result for a preservative assay - methylparaben - during stability testing of one lot.
Technology, has applications in open and minimally invasive general abdominal, gynecological, pediatric, and thoracic surgery for resection, transection, and creation of anastomosis.
Product reportedly shutting down during use.
Dreyer's Slow Churned Vanilla Bean Ice Cream;  1.5 qt, (48-fl oz.);  Lid is for Dreyer's Slow Churned Butter Pecan Ice Cream    UPC 41548 00386
Sales Team employee noticed that some cartons of 48-fl oz. cartons of Dreyers Slow Churned Vanilla Bean Ice Cream contain Butter Pecan ice cream an have a Dreyers Slow Churned Butter Pecan lid.
manufacturing code 7335580502; best by  date of 02SEP2018
Worldwide Distribution: US (nationwide) AK, AL, AR, AZ, CA, CO, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, NJ, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, and Puerto Rico; and countries of: Australia, Brazil, Canada, Chile, Colombia, El Salvador, Netherlands, Japan, Costa Rica, Spain, and Thailand.
Phoenix Nail System, 3.5mm Inserter Connector, Short; Model Numbers: 14-441045, 14-440065S (kit)     Accessory devices intended for use with an intramedullary nail system for alignment, stabilization and fixation of fractures.
Certain lots of the Phoenix Tibia Nail 3.5mm Inserter instruments are being recalled due to reports of fracturing and remaining in the device implant.
US, Canada, China, Australia, Sweden, Germany
The Operating Room Table may drift while in use, which could potentially result in unintended movement of the table.
IMRIS ORT300, Removable Operating Room Table, Part Numbers:  (a) 114093-000  (b) 114093-600
Wegmans Stores in NY, NJ, PA, VA, MD and MA.
Wegmans Avocado Summer Roll, 2 Pack, 5 oz. UPC: 2-48762-00000 or 2-48920-00000 packaged with Wegmans Thai Sweet Chili Sauce Cup 1.5 oz. (UPC 7-66630-98023)
The product is labeled as Thai Chili Sauce. The product actually contains Spicy Sauce which contains undeclared egg.
Wegmans Assorted Gyoza (Dumplings), Family Pack, 17 oz.   UPC: 2-48798-00000 or 2-48963-00000 packaged with Wegmans Thai Sweet Chili Sauce Cup 1.5 oz. (UPC7-66630-98023)
Wegmans Thai Sweet Chili Sauce Cup 1.5 oz. (UPC 7-66630-98023)
US Distribution to states of: AZ, IL NC, NH and PA.
DATEX-OHMEDA AISYS CS2 ALADIN2 CASSETTE     Cassettes are intended to be used to deliver anesthetic agent.
Non-Conforming devices were shipped from the service center without proper evaluation and therefore may be nonconforming.
Model 1100-9034-000 Mfg. Lot or Serial # BGBQ00675 and BGBQ01187
DATEX-OHMEDA TEC 7 ANESTHESIA VAPORIZER     Is designed for the metered delivery of specific inhalation anesthetic agents for use in continuous flow techniques of inhalation anesthesia.
Schwartz Brothers Restaurants dba Schwartz Brothers Bakery
Gourmet Cream Cheese Cinnamon Roll is recalled due to undeclared egg.
Reloader 250 Mineral Bolus.  A Vitamin-Mineral Bolus for Beef Cattle.  For Ruminants only.   20 Boluses Net wt. 67 oz (1.9 kg), UPC 22304-44851, Twelve 20 count boxes / carton.  40 Boluses  Net wt. 134 oz (3.8 kg)  UPC 22304-44850, Six 40 count boxes / carton.  Manufactured for:  Provimi North America, Inc., Brookville, Ohio  45309
The Reloader 250 Mineral Bolus may result in potentially releasing less vitamins and minerals per day than what the label states.
1.5 oz. cup with seal on label reading:  Thai Sweet Chili Sauce; Ingredients: Thai Sweet Chili Sauce (Sugar, Water, Pickled Red Chili, Vinegar, Garlic, Salt, Xanthan Gum); Net Wt. 1.5 oz.; coded: BB 07/04/18, BB 07/05/18
The firm received a report that 3 cups labeled as Spicy Mayonnaise Sauce was labeled as Thai Sweet Chili Sauce
Medical device software which needs to be installed.
Syngo.via software is intended to be used for viewing, manipulation, communication, and storage of medical images. It can be used as a standalone device or together with a variety of cleared and unmodified syngo based software options.
must be manually prevented from being deleted by either clinical administrator or service engineer.
All Syngo.via systems with VB20A. Model number 10496180.
Vancomycin 1g added to 250mL of 0.9% Sodium Chloride IV bag, Rx only, APOLLOcare, 3801 Mojave Ct., Suite 101, Columbia, MO 65202, NDC 71170-254-25.
Stability Data Does Not Support Expiry: 90-day beyond use date (BUD) for the affected product is not supported.
Vancomycin 1.25g added to 250 mL of 0.9% Sodium Chloride IV bag, Rx only, APOLLOcare, 3801 Mojave Ct., Suite 101, Columbia, MO 65202, NDC 71170-254-25.
diet pepsi caffeine free Classic Diet Pepsi Taste, 12 FL OZ (355 mL), UPC: 0 12000 17230 4
194 Diet Pepsi Caffeine Free 8 pack cases
Primary package is properly labeled with Aspartame containing liquid but the outer wrap states Aspartame Free.
Product was distributed in the following states:  AL, CA, FL, GA, IN, LA, MO, MS, OH, OK, PA, SC, TN, TX, WI and WV.
Southgate Hot Dog Chili Sauce 15 oz cans  UPC 0 71846 95242
The firm was notified by a customer that the product contains Dumplings with Chicken. The Dumplings with Chicken contains egg and wheat which are not listed on the label.
HEMASHIELD Knitted Double Velour Cardiovascular Fabric
A probable mislabeling of the product: a different-sized product is referenced on the product packaging label (i.e. 2.5 cm (width) x 7.6 cm (length)) while the actual product inside the box is 2.5 cm (width) x 15 cm (length).
The product has been distributed to the following States: AZ, CA, CT, GA, IL, KY, ME, NC, NJ, NY, Ok, PA, VA
Mondelez Global LLC  is initiating a  recall because  remnants of a half  peanut shell were found in two containers of bulk candy from a single lot during the repacking process and the candy is not labeled as containing peanuts.     Mondelez Global LLC  after an investigation, including inspection of product within in their control from the same lot did not find any other evidence of peanut contamination.  The firm believes this is most likely to be an isolated incident and that product on the market is unlikely to contain any peanut pieces and the product is not likely to cause adverse health consequences to peanut allergic consumers.    No adverse health events have been reported. Never the less, out of an abundance of caution, we have determined to conduct a voluntary recall to the retail level.
Retail UPC; Number of Retail Units    0 70462 43309 8; / 1 Retail Unit    Case UPC; Units Per Case    0 00 70462 00043 6; /  4 Units per Case
Domestic: IL, TX, VA, WI, OK, MS    Foreign: Canada
Product Name 	Lot Number or ID   Roasted Wing Marinade Seasoning	661107
Griffith Foods, Inc. has initiated a voluntary recall of multiple products following a supplier's recall of Autolyzed Yeast Powder due to the presence of Salmonella.
Product Name  Lot Number or ID   Roasted Wing Marinade Seasoning 661107
Product Name 	Lot Number or ID   Whiskey & Cola Type Flavored Seasoning	660373
Product Name  Lot Number or ID   Whiskey & Cola Type Flavored Seasoning 660373
Product Name 	Lot Number or ID     Premix Roasted Chicken 1258969	660025
Product Name  Lot Number or ID     Premix Roasted Chicken 1258969 660025
Product Name 	Lot Number or ID     Salt & Vinegar Seasoning - 50 LB CS	662977
Product Name  Lot Number or ID     Salt & Vinegar Seasoning - 50 LB CS 662977
Product Name 	Lot Number or ID   Toasted Italian Herbs	661126
Product Name  Lot Number or ID     Toasted Italian Herbs 661126
Product Name 	Lot Number or ID   Pan Roast Brown Gravy Mix	659281, 659282, 659283, 659284, 659285, 659286   Pan Roast Brown Gravy Mix	661090, 661089, 661091
Product Name  Lot Number or ID   Pan Roast Brown Gravy Mix 659281, 659282, 659283, 659284, 659285, 659286   Pan Roast Brown Gravy Mix 661090, 661089, 661091
Product Name 	Lot Number or ID     Fire Roasted Steak Type Seasoning	655697
Product Name  Lot Number or ID     Fire Roasted Steak Type Seasoning 655697
Product Name 	Lot Number or ID     Au Jus Seasoning Reduced Sodium	659868, 660660, 660661, 660662, 660663   Au Jus Seasoning Reduced Sodium	656387, 656388, 659864, 659865, 659866, 659867
Product Name  Lot Number or ID     Au Jus Seasoning Reduced Sodium 659868, 660660, 660661, 660662, 660663   Au Jus Seasoning Reduced Sodium 656387, 656388, 659864, 659865, 659866, 659867
Domestic: PA, IL, AR, KS    Foreign: None
Roast Chicken Marinade	SE746125 and SE746126, 50# Bags
Newly Weds Foods, Inc. initiated a voluntary recall of dry blended seasonings for industrial use due to a supplier's recall of yeast because of the presence of salmonella.
Date Manufactured, Finished Product #, Product Description, and NWF Product Lot Code  2/21/2018 G68565 Roast Chicken Marinade SE746125  2/21/2018 G68565 Roast Chicken Marinade SE746126
Au Jus Seasoning	BM652767; bulk 50 lb boxes
Date Manufactured, Finished Product #, Product Description, and NWF Product Lot Code  2/8/2018 G51631 Au Jus Seasoning BM652767
Bourbon Brown Sugar Rub SE746665, 50# Bags
Date Manufactured, Finished Product #, Product Description, and NWF Product Lot Code    2/21/2018 G96452 Bourbon Brown Sugar RubSE746665
Date Manufactured, Finished Product #, Product Description, and NWF Product Lot Code  2/9/2018 I46008 Lbs, flv roast dark type BM654892
Roast Grill Seasoning	SE746664, 50# Bags
Date Manufactured, Finished Product #, Product Description, and NWF Product Lot Code    2/21/2018 G92287 Roast Grill Seasoning SE746664
Proclaim DRG Implantable Pulse Generator, Model Number 3664
The firm received complaints of error messages that occurred during routine impedance checks on Proclaim DRG IPGs, model 3664.  Some complaints were also associated with transient over stimulation which created discomfort for the patients.
Lot Number 6210849  Serial Number AVM174.1    Lot Number 6210852  Serial Numbers:  AVA560.1, AVA214.1, AVL027.1    Lot Number 6499208  Serial Numbers:  AVD426.1, AVA922.1    Lot Number 6263128  Serial Numbers:  AVB119.1, AVD400.1, AVA622.1, AVD431.1, AVE633.1,   AVK678.1, AVN837.1     Lot Number 6268723  Serial Numbers:   AUV770.1, AVW805.1    Lot Number 6278155  Serial Number AVK896.1
Taylor Farms California Foodservice, Inc.
OK, OH, MI, MN, IA, CA, KS, WI, PA, OR, WA FL
Diced Yellow Onion 4/5# bags - 20 lb, corrugated paper carton;  20 lb. box for food service distribution.  Item number 1130025;    Taylor Farms California Foodservice;  Salinas, CA
Firm was notified by direct customer of a confirmed positive result for Salmonella ssp. after routine testing of the diced onion product.
Package code: STF066A56;  Best if used by March 24, 2018.
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
Indomethacin Capsules USP, 50 mg, 100-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Colvale-Bardez, Goa 403513, India; Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ  07430, NDC 68462-302-01.
One distributor in CA and to retail stores in CA, HI, NV.
J.M. Rosen's Cheesecake - Fantasy;   9  - Unit- 64 Slices in a case box;  Product #55993  UPC 6 89076 70759 6;   INGREDIENTS: Cream Cheese (Pasteurized Milk. and Cream, Cheese Culture, Salt, ( Stabilizers (Xanthan Gum, and/or Carob Bean Gum, and/or Guar Gum), Unbleached flour, (unbleached Wheat Flour, Thiamine Mono-nitrate, Niacin, Iron, , Riboflavin. Folic Acid, Malted barley, flour) Granulated Sugar, Eggs, unsalted Butter (Cream (Milk)), Sour Cream (Milk. - Enzymes), Cream, milk, Orange and Lemon Rind, NielsonMasseyVanilla),   Chocolate layer cake sour cream, Unbleached Flour. Dark brown sugar, Eggs, Water, Butter, Chocolate (Cocoa Bean, Sugar; Soy Lecithin, Pure Vanilla, Soybean Oil,  Cocoa Powder, Baking powder, baking soda,  Vanilla Extract, Chocolate Mousse (Cream, Water, Powdered Sugar, Cocoa Powder; Gelatin, Mousse Base{Sugar; Cocoa Powder, Dextrose, Gelatin, Salt), Chocolate. Ganache (Cacao Bean, Sugar, Soy lecithin Vanilla), Dark Chocolate Topping (Cocoa Mass, sugar, cocoa butter, Milkfat, Soy Lecithin  Natural Vanilla  Contains: Eggs, Milk, Wheat
Retail store employee noticed a small rubber object in the cheesecake - the firm is recalling the entire day's production.
J.M. Rosen's Cheesecake - New York Traditional;   6 - Unit- 4/46 oz in a case box;  Product #56378  UPC 6 93892 99462 7;   INGREDIENTS: Cream Cheese (Pasteurized Nonfat Milk, and Milkfat~ Whey  Protein Concentrate, Cheese Culture. Salt, Whey, Stabilizers (Xanthan Gum,  and/or Carob Bean Gum, and/or Guar Gum)}, Unbleached Flour,  (Unbleached Wheat Flour, Thiamine Mono-nitrate, Niacin. Iron, Riboflavin,  Folic Acid, Malted Barley Flour), Granulated Sugar Cane, Eggs, Unsalted  Butter (Cream {Milk)), Sour Cream (Milk, Enzymes). Cream {Milk), Orange  and Lemon Rind, Nielson Massey Vanilla).
Software issue with Center Beam in Field functionality. Issue can result in incorrect treatment volume delivered to patient.
Cole Slaw, Store Made. Packed in deli-style plastic containers:  Weis, Weis Markets, Inc., Sunbury, PA; Cabbage, Carrots, Pineapple, White Onions, Sugar, Salt Pepper, Vinegar, Hellmanns Mayonnaise
The ingredient label failed to declare egg because the store-made coleslaw scale label did not list the sub-ingredients of mayonnaise.
Fosphenytoin Sodium Injection, USP 500 mg PE*/10 mL, Made in India. Distributed by: Amneal Biosciences, Bridgewater, NJ 08807, NDC 70121-1390-1
Worldwide Distribution - USA (nationwide) Distribution and to the countries of :  Australia, France, Saudi Arabia, Germany, and France.
F-T3SYSTEM, T3 (Trumpf Table Top) System      The device is a surgical table accessory system used to allow prone positioning on OR table tops during spinal surgery. The system consists of a table top frame, arm supports,
The recalling firm has become aware that the rail section clamps used to attach the leg support of the device may fail during use, which could result in critical harm to the patient.
24-HOUR Oral Care q2 Kit with Ballard* Technology, containing 2 Toothbrush Packs with CHG Solution, Chlorhexidine Gluconate Oral Rinse, 0.12%, 15 mL unit dose cup (NDC 50383-720-15), Rx Only, Hi-Tech Pharmacal Co., Inc. Amityville, NY 11701; Kit Manufactured by Halyard Health, Inc., 5405 Windward Parkway, Alpharetta, GA  30004; Distributed in the USA by Halyard Sales, LLC, Alpharetta, GA 30004, Product 97012.
Subpotent Drug: Product crystallization with accompanying low out of specification results for chlorhexidine assay.
24-HOUR Oral Care q4 Kit with Ballard* Technology, containing 2 Toothbrush Packs with CHG Solution, Chlorhexidine Gluconate Oral Rinse, 0.12%, 15 mL unit dose cup (NDC 50383-720-15), Rx Only, Hi-Tech Pharmacal Co., Inc. Amityville, NY 11701; Kit Manufactured by Halyard Health, Inc., 5405 Windward Parkway, Alpharetta, GA  30004; Distributed in the USA by Halyard Sales, LLC, Alpharetta, GA 30004, Product 97014.
Chlorhexidine Gluconate Oral Rinse, 0.12%, 15 mL unit dose cups (NDC 50383-720-15) packaged in 100-count (10 x 10) cups per case pack (NDC 50383-720-18 or 50383-720-19), Rx Only, Hi-Tech Pharmacal Co., Inc., Amityville, NY 11701.
Distributed in AZ.  No VA/Govt/Foreign consignees.
diet Pepsi Classic Diet Pepsi Taste, 12oz cans, sold as a 12 pk, ambient storage.
PepsiCo is recalling Diet Pepsi due to mislabeling.