Archive
567 recalls were announced in December 2019.
Of the 567 recalls this month scored against our rubric, 8% are Critical, 28% are Severe.
Which agencies issued them
Zimmer Biomet is recalling Comprehensive HHR Tess Cleats because elevated levels of bacterial endotoxin and residual debris remain on the devices due to a cleaning issue.
Foundation Medicine is recalling eight FoundationOne CDx test reports due to identified potential false positive MSI-H results.
Helena Laboratories is recalling Platelet Aggregation Kits because the Collagen Reagent vials may contain particulate matter or microbial growth.
Boston Scientific is recalling 14,145 Rebel Monorail PtCr Coronary Stent Systems because they may be missing a hydrophilic coating step.
Howmedica Osteonics Corp. is recalling 40 units of Stryker X-Change Medial Wall Mesh Small (6-Petal) because boxes contain the 4-Petal version instead.
Wright Medical Technology is recalling 20 Swanson Trapezium Implants because the firm discovered a lack of adequate documentation confirming sterility.
Goya Foods is recalling 14-ounce bags of whole Tamarillo fruit because the product tested positive for pesticides not approved for use in this commodity.
Wright Medical Technology is recalling 40 units of Ortholoc 3DI locking screws because documentation confirming sterility was inadequate.
Abbott is recalling Alinity ci Level Sensor Bulk Solution kits due to potential cracks caused by environmental stress, which may affect reliability.
Boston Scientific is recalling 54 units of Advanix Pancreatic Stents because they were labeled with a 36-month shelf life instead of the approved 18-month duration.
Boston Scientific is recalling 35 units of Advanix Pancreatic Stents because they were labeled with a 36-month shelf life instead of the approved 18-month shelf life.
Nextremity Solutions is recalling 49 units of Stratum Foot Plating System screws because they may contain the incorrect screw type and length.
Boston Scientific is recalling 66 units of Advanix Pancreatic Stents because they were labeled with a 36-month shelf life instead of the approved 18-month shelf life.
Medline Industries is recalling EVENCARE G3 Blood Glucose Test Strips because incomplete seals may cause the strips to expire prematurely.
Boston Scientific is recalling Guidezilla II Guide Extension Catheters because they may lack a hydrophilic coating, potentially affecting device performance.
Wright Medical Technology is recalling 20 units of Swanson Finger Joint #1 implants because documentation confirming sterility was inadequate.
Boston Scientific is recalling NC Emerge Monorail PTCA Dilatation Catheters because they may be missing a hydrophilic coating step during manufacturing.
Wright Medical Technology is recalling 30 units of Evans Opening Wedge Plates because documentation confirming sterility was inadequate.
Wright Medical Technology is recalling 42 units of CPS Calcaneal Plates because the firm discovered a lack of adequate documentation confirming sterility.
Bard Peripheral Vascular Inc is recalling 900 units of PowerPort isp M.R.I. Implantable Ports because they were packaged with the incorrect introducer sheath size.
Boston Scientific is recalling 109 units of Advanix Pancreatic Stents because they were labeled with a 36-month shelf life instead of the approved 18-month shelf life.
Boston Scientific is recalling Advanix Pancreatic Stents because they were labeled with a 36-month shelf life instead of the approved 18-month shelf life.
Wright Medical Technology is recalling 54 units of Valor Screws because adequate documentation confirming sterility was missing.
Boston Scientific is recalling Advanix Pancreatic Stents labeled with a 36-month shelf life instead of the approved 18-month duration.
Boston Scientific is recalling 139 units of Advanix Pancreatic Stents because they were labeled with a 36-month shelf life instead of the approved 18-month shelf life.
Wright Medical Technology is recalling 77 units of Dart Fire Headed Screws because the firm discovered a lack of adequate documentation confirming sterility.
Boston Scientific is recalling 940 Advanix Pancreatic Stents because they were labeled with a 36-month shelf life instead of the approved 18-month shelf life.
Wright Medical Technology is recalling 30 Swanson Great Toe implants because the firm discovered a lack of adequate documentation confirming sterility.
Boston Scientific is recalling 97 Advanix Pancreatic Stents because they were labeled with a 36-month shelf life instead of the approved 18-month duration.
Great Lakes Cheese Co Inc is recalling 5 lb. loaves of pasteurized process American cheese due to potential metal foreign material.
Great Lakes Cheese Co Inc is recalling specific brands of American cheese loaves because they may contain metal foreign material.
Great Lakes Cheese Co Inc is recalling 1,273 cases of pasteurized process American cheese due to potential metal foreign material.
Boston Scientific is recalling Advanix Pancreatic Stents because they were labeled with a 36-month shelf life instead of the approved 18-month period.
Whole Foods Market is recalling 365 Everyday Value Organic Instant Oatmeal cups due to undeclared wheat. The product was distributed in Colorado and Pennsylvania.
Rocket Medical Plc is recalling 1,081 KCH Fetal Bladder Drainage Catheters due to reported kinking and off-label use for pleural drainage.
Water Gardens Confections LLC is recalling Pip Pop Movie Theater Popcorn because foreign material from packaging was found in the product.
Great Lakes Cheese Co Inc is recalling Prima Della Delicatessen Pasteurized Process Sharp American Cheese because 5 lb. loaves may contain metal foreign material.
Beatrice Bakery Co is recalling 1,521 cakes of Nut Bread because the product showed mold growth before its best-by dates.
Abbott is recalling Alinity ci Level Sensors, Bulk Solution, because environmental stress may cause cracks that affect reliability.
Lift Chocolate, LLC is recalling Boulder Chocolate Maple Pear Brandy Flambe Truffles due to the presence of internal mold. The affected product was distributed in Oregon.
Boston Scientific is recalling 179 Advanix Pancreatic Stents because they were labeled with a 36-month shelf life instead of the approved 18-month shelf life.
Abbott is recalling Alinity i accessory kits because environmental stress may cause cracks in the bulk solution level sensor.
Helena Laboratories is recalling Collagen Reagent kits because vials may contain particulate matter or microbial growth.
Wright Medical Technology is recalling 66 units of sterile headed drill bits because documentation confirming sterility was inadequate.
Wright Medical Technology is recalling 19 units of PRO-STIM 10cc Injectable because adequate documentation confirming sterility was missing.
Wright Medical Technology is recalling 65 units of INBONE STEM, TIBIAL, TOP components because adequate documentation confirming sterility was not found.
Boston Scientific is recalling 271 Advanix Pancreatic Stents because they were labeled with a 36-month shelf life instead of the approved 18-month shelf life.
Wright Medical Technology is recalling 18 units of Swanson Finger Joint #2 implants because documentation confirming sterility was inadequate.
Vygon MFG, Inc. is recalling 75 units of 4Fr x 20cm Single Lumen CT Midline Basic Trays because a 3Fr catheter may have been packaged instead of the correct 4Fr size.
Boston Scientific is recalling 66 units of Advanix Pancreatic Stents because they were labeled with a 36-month shelf life instead of the approved 18-month shelf life.
Avantor Performance Materials Inc is recalling bulk Potassium Phosphate, Monobasic, Crystal due to failed stability specifications for iron content.
AuroMedics Pharma LLC is recalling Amiodarone Hydrochloride Injection vials due to the presence of visible particulate matter (crystallization). The affected lots were distributed nationwide in the US.
Spineart SA is recalling 14 JULIET Ti OL cages due to a mismatch between the inner blister pack label and the external box label.
United States Bakery Corp is recalling Great Value Old Fashioned Glazed Donuts because packaging glue was found inside the boxes.
AuroMedics Pharma LLC is recalling 28,810 vials of Amiodarone Hydrochloride Injection due to the presence of visible particulate matter.
Great Lakes Cheese Co Inc is recalling 2,487 cases of pasteurized process American cheese loaves because they may contain metal foreign material.
Merical, LLC is recalling Leader Advanced Probiotic capsules because the label lists the wrong probiotic blend. Consumers should stop using the product.
AuroMedics Pharma LLC is recalling Amiodarone Hydrochloride Injection vials due to the presence of visible particulate matter (crystallization). The affected lots were distributed nationwide in the US.
Great Lakes Cheese Co Inc is recalling 4,700 cases of pasteurized process American cheese loaves that may contain metal foreign material.
Spectranetics Corporation is recalling three AngioSculpt PTCA Scoring Balloon Catheters because the incorrect outer carton box was used for the product.
Zamzow is recalling one Aero Easy Cover tarping pawl assembly because a missing weld may cause the part to separate, increasing injury risk.
Piaggio is recalling 399 2020 Moto Guzzi V85 TT motorcycles because footrest mounting clips may break, causing the footrest to fall off and create a road hazard.
REV Ambulance Group is recalling 2018-2019 Wheeled Coach Type 1 ambulances because oxygen tank brackets may loosen, posing an injury risk in crashes.
Subaru is recalling 51,613 2019 Crosstrek, Forester, and Ascent vehicles because a PCV valve can separate, causing loss of power and increasing crash risk.
Subaru is recalling 2019 Ascent vehicles because a faulty transmission sensor may cause loss of drive power and increase crash risk.
IMT Standen is recalling certain leaf spring assemblies for trailers because they may crack and break, posing a road hazard and increasing crash risk.
Piaggio is recalling 2020 Moto Guzzi V85 TT motorcycles because a final drive seal may leak oil onto the rear tire, increasing crash risk.
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