Giant Eagle Apple Pistachio Salad, NET WT 13 oz.
The sliced red apples were recalled due to potential contamination with Listeria monocytogenes.
Giant Eagle Apple Pistachio Salad with Chicken, NET WT  15 oz.
Distribution was nationwide to medical facilities.  There was also military and government distribution.
The Schiller PB 1000, also known as: Merge Hemo Patient Data Module (PDM), V2 model, a major component of the Merge Hemo software.
341 sites potentially have the affected product versions
Non-invasive blood pressure pumps (NIBP) voltage is not sufficient and causes the NIBP pumps to fail prior to reaching adequate initial pressure.
Patient Data Module (PDM) V2 model:  Serial numbers 10.03.XXXXX
Worldwide Distribution - US (nationwide) and Internationally to Canada and Mexico
To facilitate postoperative collection and reinfusion of autologous blood from the patients pleural cavity or mediastinal area
Chest drains manual vent valve located at the top of affected chest drains could potentially not re-seal after being depressed.
To facilitate postoperative collection and reinfusion of autologous blood from the patients pleural cavity or mediastinal area.
MegaJex Herbal Supplement, Maximum Formula for Men, Fast acting, Increase Stamina, 20 capsules, MS Bionics, Gardena, CA
Marketed without an Approved NDA/ANDA; product contains sildenafil and tadalafil which are active pharmaceutical ingredients in FDA approved drugs used to treat erectile dysfunction (ED)
SLIMFIT X capsules, packaged in a 60-cont bottle
Marketed without an approved NDA/ANDA: Product contains undeclared sibutramine and desmethylsibutramine.
Worldwide Distribution - USA (nationwide) to the states of : AL, AR, AZ, CA, CO, CT FL, GA, IL, IN, KS, LA, MA, MD, ME, MI, MN, MO, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, WA and WV;  and to the country of Canada and others.
There is a remote possibility CentraLink may download an order to the ADVIA Automation System without specifying the sample type. This can occur when an order is received from the LIS without a sample type, requiring that the sample type be set in CentraLink based on the sample type of the test in the order.
Nationwide.   CANADA   AUSTRALIA                  CHILE                      COLOMBIA                   KOREA  Netherlands
Comprehensive Reverse Shoulder System Humeral Tray  Model 115340
Higher than anticipated rate of fracturing due to design.  Risk of revision surgery due to fracturing.
Worldwide Distribution - US Nationwide in the states of AL, AZ, CA, CO, CT, FL, GA, ID, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, NC, NH, NJ, NM, NY, OH, OK, OR, PA, RI, TN, TX, UT, VA, WA, WI, WV, & WY and the countries of Italy, Germany, Australia, China, Europe, Hong Kong, South Africa, Germany, Thailand & Singapore.
Stryker Restoris RIO Reamer Handle, Offset, Mako Rx only     Product Usage:  The handle is used to hold surgical components during acetabular reaming in MAKO Total Hip procedures.
Failure of the Offset Cup Reamer Handle not engaging its mating components.
Lisinopril tablets, 5 mg, 1000-count bottle, Rx only, Manufactured for Accord Healthcare, Inc., Durham, NC 27703, NDC 16729-376-17
Failed tablet/capsule specification: missing break line on the 5mg tablet.
Atrium PVC 10 Fr Straight Thoracic Catheter	  Code Number: 8010
Labeling  icon depicts a catheter having six (6) eyelets; however the correct number of eyelets on the 8 Fr and 10 Fr thoracic catheters is two (2)
All Lot Numbers With Expiration Date Prior To December 2019
Atrium PVC  8 Fr Straight Thoracic Catheter	  Code Number: 8008
According to the firm the product was distributed in New Jersey, Pennsylvania, Maryland, Virginia, District of Columbia, Ohio, Kentucky.
Whole Foods Market, TART FRENCH APPLE SMALL
According to the firm, packaged crusts used in various tarts these tarts contains Almond Flour (Nuts) which is listed as an ingredient on the package, but is not listed as an ingredient on the WFM scale label.
Whole Foods Market, TART FRESH FRUIT AMERO SHELL LARGE
24984100000 TART FRESH FRUIT AMERO SHELL LARGE
Whole Foods Market, TART CHOCOLATE GANACHE SMALL, TART CHOCOLATE GANACHE LARGE
24978300000 TART CHOCOLATE GANACHE SMALL  24977900000 TART CHOCOLATE GANACHE LARGE
Whole Foods Market, SMALLTART FRESH BERRY SMALL, TART FRESH BERRY LARGE
24983100000 TART FRESH BERRY SMALL  24983000000 TART FRESH BERRY LARGE
Whole Foods Market, TART KEY LIME 4IN  TART KEY LIME 4IN,TART KEY LIME 9IN
24989600000 TART KEY LIME 4IN  23144500000 TART KEY LIME 4IN  24988900000 TART KEY LIME 9IN
Whole Foods Market, TART PEANUT BUTTER CHOCOLATE
22024600000 TART PEANUT BUTTER CHOCOLATE  22061300000 TART PEANUT BUTTER CHOCOLATE  22061400000 TART PEANUT BUTTER CHOCOLATE
Worldwide Distribution-US ( nationwide) in states of: AZ, CA, CO, CT, FL, GA, IA, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SD, TX, VA, WA, WI, and WV and countries of: Australia, Brazil, Canada, Czech Republic, Denmark, Finland, France, French Guiana, Germany, India, Ireland, Israel, Italy, Japan, Latvia, Lithuania, Luxembourg, Malaysia, Netherlands, New Zealand, Norway, Poland, Qatar, Saudi Arabia, Slovenia, South Africa, Sweden, Turkey, United Arab Emirates, and United Kingdom.
LIFEPAK 15 Monitor, Automated External Defibrillator (AED), Manual mode monitoring and therapy functions are intended for use on adult and pediatric patients. Automated external defibrillation mode is intended for use on patients eight years of age and older.
338 units total (US =139 units; International = 199 units)
The firm has become aware of a potential device issue where the LIFEPAK 15 device may no longer be able to deliver defibrillation energy due to a potential failure of an internal component (Relay) installed on the Therapy Printed Circuit Board Assembly (PCBA).
Joe Chips Retro Potato Chips Sour Cream & Toasted Onion   Distributed by: The Joe Tea Company, Upper Montclair, NJ 07043-0255 (973)744-7502  Net Wt. 2 OZ  UPC 743234001725  Net Wt. 5 OZ UPC 743234001800
Joe Chips Sour Cream & Toasted Onion Retro Potato Chips contains a seasoning with a milk powder ingredient that may be contaminated with Salmonella although firm testing has not revealed the presence of the bacteria.
expiration    2 oz size 27-MARCH-2017 THRU 09-JUL-2017  5 oz size 28-AUG-2017 THRU 19-NOV-2017
Domestic: 0    Foreign: Singapore & Malaysia
Vanguard Total Knee, PUNCH THRU TRL PLATES, 63 MM Item No: 32-487261, 67 MM Item No: 32-487262, 71 MM Item No: 32-487263, 75 MM Item No: 32-487264, and 79 MM Item No: 32-487265
Zimmer Biomet is conducting a medical device recall for ARCOS & TPRLC broaches and rasps due to potential alumina inclusions in the raw material batch used to produce the affected products. Inclusions contained within the finished product could lead to the cracking and separation of the instrument.
Products were distributed in the following states:  AZ, CA, CO, DC, DE, FL, GA, IL, LA, MA, MD, MN, MO, MS, MT, NC, NJ, NY, OH, OK, OR, PA, PR, TX, VT, WA, &  WI.    Product was distributed internationally to the following countries: Australia, Austria, Belgium, Brazil, Canada, Chile, China, Czech Republic, Denmark, France, Gabon, Germany, Greece, India, Indonesia, Ireland, Israel, Italy, Japan, Korea, Lebanon, Lithuania, Malaysia, Netherlands, New Zealand, Norway, Panama, Poland, Portugal, Russian Federation, Saudia Arabia, Slovakia, South AFrica, Apain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, United Kingdom,  and Viet Nam.
The intended use listed in the English and localized language IFUs for BrightView XCT systems did not match the intended use documented in the 510K submission.
Two systems were converted into the BrightView XCT and are included in the codes for prouct 1.
Worldwide Distribution - USA (nationwide) including Puerto Rico and to the countries of : Australia, China, Hong Kong, India, Indonesia, Korea (South), Malaysia, New Zealand, Philippines, Singapore, Sri Lanka, Taiwan, Thailand, Vietnam, Canada, Belgium, Czech Republic, Egypt, France, Germany, Great Britain, Greece, Hungary, Ireland, Israel, Italy, Netherlands, Poland, Portugal, Qatar, Russian Federation, Saudi Arabia, Slovenia, South Africa, Spain, Sweden, Switzerland, Turkey, United Arab Emirates, Japan, Argentina, Bolivia, Brazil, Chile, Colombia, Ecuador, Guatemala, Mexico, Panama, Peru,  Uruguay, and Venezuela.
STERRAD NX Sterilization System, Product Code: 10033, 10033-002
Advanced Sterilization Products (ASP) has identified that in a rare sequence of events following an external power outage, the system door interlock can be become disengaged during system reboot for a 20-second duration.
US Nationwide - US Nationwide in the states of MS, OH, RI, NY, OK, TX, CA, HI
LIMA Modular Revision Hip Stem Model 428-01-050_110    Product Usage:  The Modular Revision Femoral hip stem is made up of a modular stem coupled with a proper neck by means of a Morse taper stabilized during the implantation phase by a safety screw. This system is particularly indicated for revision surgery on both uncemented and cemented femoral implants, when there is significant bone loss and an abnormal meta-epiphyseal anatomy of the femur.
Lima Proximal Bodies were inadvertently re-sterilized. The safety screw which affixes the distal and proximal bodies of the stem includes a thread-locking plug made from UHMWPE, which is not approved for repeated gamma sterilization.
GN200 Caiman HF generators, electrosurgical, cutting & coagulation & accessories
Generators may have a faulty component which could impact the proper functioning of the device.
Worldwide Distribution - US Nationwide in the states of IN and the countries of Canada, Austria, Germany, Japan.
On June 14, 2016, Greatbatch discovered a significant increase in the number of field complaints for the T5766 Offset Reamer Handle in which the U-joints of the drive chain component seizes during orthopedic procedures rendering the device non-functional. The 2016 failure rate for this failure exceeds the occurrence rate as defined in the DFMEA.
During use, there is a potential scenario which could allow the fastening screws attaching covers to come loose and potentially land in the sterile field causing a delay in surgery.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
PIER FISH CO. 68 CONWAY ST NEW BEDFORD, MA 02740 COLUMBUS FISH & SFD TUNA GRIND LOT# 16185 PRODUCT OF : USA HARVESTED: WILD CAUGHT NET WT: 20 LBS
AL, AR, IA, IL, IN, KY, LA, MO, NC, OH, OK, PA, TN, TX, VA
PICTSWEET(R)  FARMS, Southern Classics, Crunchy Breaded Okra, NET WT 12 OZ (340g), UPC 7056098377
27,210 units; (4535 cases of 6 units/case)
date of Nov 3, 2018 and a production code of 3086B C, 3086B D, 3086B E, 3086B F, or 3086B G
During development of the VIDAS 3 software version 1.2, some anomalies have been identified and observed to be already present in the current software version VIDAS 3 version 1.1.4. available in the field.
REF: #412590, Lot: Software version 1.1.4
Nationwide, Bulgaria, Serbia, Cyprus, United Kingdom, Spain, Netherlands, Sweden
Product's supplement fact panel incorrectly states that the product contains 75 mg (milligrams) of Molybdenum, when it actually contains 75 mcg (micrograms).
Posterior tibial fractures have been reported.
Model Number, Item Description, and Lot Number: 10207101, Cadence Tibial Tray, Size 1, Right Lots: QJ0231, QJ0231-G, QJ0467, QJ0467-G; 10207102 Cadence Tibial Tray, Size 2, Right Lots: QJ0227, QJ0227-G, QJ0233, QJ0469, QJ0500, QJ0500-G; 10207103 Cadence Tibial Tray, Size 3, Right Lots: QJ0235, QJ0235-1, QJ0235-1-G, QJ0471, QJ0502-G; 10207104 Cadence Tibial Tray, Size 4, Right Lots: QJ0237, QJ02371, QJ0237-1G, QJ0237-G, QJ0473, QJ0504-G; 10207105 Cadence Tibial Tray, Size 5, Right Lots: QJ0239, QJ0239-1-G, QJ0239G, QJ0475;  10207111 Cadence Tibial Tray, Size 1X, Right Lots: QJ0232, QJ0232-G, QJ0468, QJ0499-G; 10207112 Cadence Tibial Tray, Size 2X, Right Lots: QJ0228, QJ0228-G, QJ0234, QJ0234-G, QJ0470, QJ0501-G; 10207113 Cadence Tibial Tray, Size 3X, Right Lots: QJ0236, QJ0236-1, QJ0236-1-1G, QJ0236-1G, QJ0472, QJ0503, QJ0503-G;   10207114 Cadence Tibial Tray, Size 4X, Right Lots: QJ0238, QJ0238G, QJ0474, QJ0505-G; 10207201 Cadence Tibial Tray, Size 1, Left Lots: QJ0240, QJ0240G, QJ0249, QJ0476; 10207202 Cadence Tibial Tray, Size 2, Left Lots: QJ0242, QJ0242-1-G, QJ0242-2-G, QJ0242-G, QJ0478, QJ0478-G, QJ0507-G;   10207203 Cadence Tibial Tray, Size 3, Left Lots: QJ0244, QJ0244G, QJ0253, QJ0480, QJ0480-G, QJ0509-G; 10207204 Cadence Tibial Tray, Size 4, Left Lots: QJ0246, QJ0246G, QJ0255, QJ0482; 10207205 Cadence Tibial Tray, Size 5, Left Lots: QJ0248, QJ0248G, QJ0257, QJ0484; 10207211 Cadence Tibial Tray, Size 1X, Left Lots: QJ0241, QJ0241G, QJ0477, QJ0477-G, QJ0506;   10207212 Cadence Tibial Tray, Size 2X, Left Lots: QJ0243, QJ0243G, QJ0252, QJ0479, QJ0479-G, QJ0508, QJ0508-G; 10207213 Cadence Tibial Tray, Size 3X, Left Lots: QJ0245, QJ0245G, QJ0481, QJ0481-G, QJ0510, QJ0510-G; 10207214 Cadence Tibial Tray, Size 4X, Left Lots: QJ0247, QJ0247-G, QJ0256, QJ0483, QJ0483-G, QJ0511, QJ0511-G
Worldwide Distribution - US (nationwide) and Internationally to Switzerland, Canada, Australia, New Zealand, Ecuador, Colombia, and Japan.
T-LOK BONE MARROW BIOPSY NEEDLE 8G x 4 EXT CAN; T-LOK BONE MARROW BIOPSY NEEDLE 11G x 4 EXT CAN    Intended for the purpose of harvesting bone and/or bone marrow specimens
The recalling firm received a complaint from one of their customers of a potential defect in the forming of  the primary package of the blister that may compromise the sterility of the product inside the tray.
HARVEST NEEDLE 15GA X 2    Intended for the purpose of harvesting bone and/or bone marrow specimens
BONE MARROW ASPIRATION NEEDLE 15G x 2.688 MAX and 15G x 4 MAX    Intended for the purpose of harvesting bone and/or bone marrow specimens
Distributed throughout the United States
Complaints of positive shift of patient and QC results when the ALTI assay is calibrated with the Dimension Enzyme II calibrator.  Internal investigation has confirmed that patient samples and QC material demonstrate a shift of up to 10% in comparison to results obtained using earlier calibrator lots.
The Enzyme 2 Calibrator is an in vitro diagnostic product for the calibration of Alanine Aminotransferase (ALTI and ALTI) and Aspartate Aminotransferase (AST) methods on the Dimension Vista System.  For prescription use only.
Complaints of positive shift of patient and QC results when the ALTI assay is calibrated with the Dimension Vista Enzyme 2 calibrator.  Internal investigation has confirmed that patient samples and QC material demonstrate a shift of up to 10% in comparison to results obtained using earlier calibrator lots.
Worldwide Distribution - US Nationwide and the countries of Canada, Mexico, Indonesia
BD Vacutainer  Buffered Sodium Citrate: (9NC) Blood Collection Tube (4.5 ml x 13 x 75 mm)  Catalog Number: 369714    Product Usage:  The BD Vacutainer Safety Coagulation tube is an evacuated blood collection tube that provides means of collecting, transporting and processing blood in a closed tube. The buffered sodium citrate additive provides an anti-coagulated specimen that may be used for clinical laboratory coagulation assays and determinations
A portion of this lot of blood collection tubes was manufactured with approximately twice the expected amount of buffered sodium citrate additive, an anticoagulant.
TX. NC, NY, FL, WI, KY, MI, CA, TN, GA, KS, MN, IA, OH, MA, HI, Guam, Nothern Mariana Islands, and Puerto Rico
Pizza Hut Creamy Alfredo sauce, case size 40 lbs. 8 bags per case. Bags are each 80 oz (5 lbs) of sauce
Foreign object in alfredo sauce. Likely flexible plastic.
Venlafaxine Hydrochloride extended release capsules, 37.5 mg, 30-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc. 2400 Route 130 North, Dayton, NJ 08810 Manufactured by: Aurobindo Pharma Limited Hyderabad-500 072 India, NDC 65862-527-30
Failed Tablet/Capsule Specifications: Some bottles contain  punctured, and/or clumped/melted capsules.
Worldwide Distribution - Costa Rica, Malaysia, Mexico, South Africa, and Spain
6-hole Pubic Symphysis plate (PN 70-0451).  The pelvic bone plates for the pelvic ring are a series of plates with varying lengths that function as internal fixation devices for fractures, fusions and osteotomies of the pelvic ring. The plates are strategically pre-contoured where beneficial to the application, and they are secured to the bone with  3.5mm non-locking screws. The Acumed pelvic ring plate is the Pubic Symphysis Plate.      The Acumed Pelvic Plating System is intended for use by surgeons with orthopedic training and knowledge of the indications and techniques required for fixation. The device is to be implanted by the surgeon in a sterile operating room setting.
Terumo   Cardiovascular   has  identified   16  domestic   consignees   and  30   international consignees .
Hercules 360 Universal Stabilizing Arm, top mount, 360-degree rotation, reusable stainless steel
The total number of distributed devices stands at 260
Terumo Cardiovascular Systems (Terumo CVS) is recalling certain lots of Hercules TM 360 Universal Stabilizing Arms because the two pins that hold the sleeve attached to the distal end of the device may come loose, causing the pins and sleeve to separate from the device. While the arm can still function without the pins and sleeve in place, there is potential for the loose components to fall into the surgical site.
Blood and Blood Products for Reprocessing
Blood products, for which donor eligibility was incorrectly determined, were distributed.
Red Blood Cells, Leukocytes Reduced, Irradiated
Plasma products, for which a failure to quarantine units due to medical history occured, were distributed.
U.S. distribution to the following; MA, CA, FL, UT, AZ, WI, NY, OR, IN, MO, IL, NJ, KS, CO, CT, VT, NM, HI, NV, IA, OH, WA, RI, MI.    Foreign distribution to the following; Grand Cayman.
Burts British Hand Cooked Potato Chips  Sea Salt & Malted Vinegar  150gx10 and 40gx20
Product is labeled as gluten free; however was labeled as containing an ingredient with gluten.
Taclonex (calcipotriene and betamethasone dipropionate)  Topical Suspension, 0.005%/0.064%, packaged in (a) 60 g (NDC 50222-501-06), and  (b)120 g (50222-501-66)  tubes,  Rx Only, Manufactured by: LEO Laboratories Ltd., 285 Cashel Road, Dublin 12 Ireland, Distributed by: LEO Pharma Inc. 1 Sylvan Way, Parsippany, NJ 07054.
Labeling: Incorrect or missing package insert:  the affected product was packaged with an out-of-date package insert (PI) dated February 2014.
Domestic: None  VA/DOD: None  Foreign: Japan
1.5mm System, Cranio-maxillofacial Bone Screws  1.5 x 4mm HT SD X-DR Screw, Bone Screw
The identification of the devices was non-conforming with off-centered slots and the no-go gage starting in the pilot hole.
95-6104- Item No.   530430- Lot  1.5x4mm HT SD X-DR Screw
Worldwide Distribution- US (nationwide) including states of: CA, DC, IL, MN, MO, NY, SC, TX, WI, WV; and countries of: Canada, Czech Republic, Denmark, Finland, France, Germany, Italy, Netherlands, Norway, Poland, Saudi Arabia, Spain, Sweden, Switzerland, Taiwan, United Kingdom, and Uruguay.
Discovery MR450    The Discovery MR750 3.0T, Discovery MR450 1 .5T, Discovery MR750w 3.0T and the Optima MR450w I.5T systems are whole body magnetic resonance scanners designed to support high resolution, high signal-to-noise ratio, and short scan times. It is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images, spectroscopic images, parametric maps. and/or spectra, dynamic images of the structures and/or functions of the entire body, including, but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate. blood vessels, and musculoskeletal regions of the body.
Potential safety issue with the patient bore heating on the Discovery MR450 narrow bore 1.5T MRI. In the event of a RF component failure, typically happening after extended system use, a small area on the bore surface may become warmer than normal. If this happens in an area where there is patient contact with the bore, and proper padding is not used, it may cause a serious burn.
Mimvey Lo (estradiol and norethindrone acetate tablets USP), 0.5 mg/0.1 mg, 28 tablets per blister card (NDC 0093-5454-18), packaged in 3 blister cards per carton (NDC 0093-5454-62), Rx only, Manufactured By: Barr Laboratories, Inc., Pomona, NY 10970; Manufactured For: Teva Pharmaceuticals USA, Sellersville, PA  18960.
Failed Impurities/Degradation Specifications: out of  specification test results for the norethindrone impurity.
Blood products, collected from ineligible donors based on testing for relevant transfusion transmitted infection testing, were distributed.
Apheresis Red Blood Cells, Leukocytes Reduced
Washed Red Blood Cells, Leukocytes Reduced, Irradiated
Glipizide extended-release tablets, 2.5mg, 30-count bottle,  Rx Only,  Manufactured By Patheon Pharmaceuticals Inc Cincinnati OH 45237 USA, NDC 0591-0900-30, UPC 3-0591090030-4
Failed Dissolution Specifications. Above out of specification for dissolution rate observed at the 10 hour testing point.
US: Germany, Italy, Puerto Rico, Spain, Sweden, Switzerland,
StarClose SE Vascular Closure System, Part No. 14679-01, 14679-02.    The UDI is 08717648079467.  The GMDN is 47411.
170,008 units total (83,029 units in US)
Abbott Vascular is recalling the StarClose SE Vascular Closure System because it may exhibit difficulty or failure to deploy the StarClose SE Clip.
Siemens became aware of Incorrect values for the rotational collimator position displayed due to mechanical problems of the sensor slide.  In addition, there are improper weld seam at the overhead suspension.
Crystal Geyser became aware of a potential safety issue for sparkling water produced from January 31 - February 1, 2017 as a piece of orange plastic from the filler tube was discovered to be missing.