Archive
806 recalls were announced in December 2016.
Of the 806 recalls this month scored against our rubric, 13% are Critical, 22% are Severe.
Which agencies issued them
Suzuki is recalling about 3,400 KingQuad 750 ATVs because the battery can fail, causing the engine to stop and posing a crash hazard.
Brownwood Farms is recalling BBQ Mustard Glaze because it contains soy ingredients not declared on the label.
Northern Fish Products is recalling hot smoked salmon, black cod, steelhead, and trout because they contain undeclared soy.
Hummingbird Wholesale is recalling Ariels OM Grown Granola because it was contaminated with wheat seed. The product was distributed in California, Oregon, and Washington.
Fairway Market is recalling Candy Corn for potentially containing undeclared egg. The product was sold in New York, New Jersey, Connecticut, and online.
Wakefern Food Corp. is recalling 24-count chocolate chip cookies due to the potential presence of metal pieces. The product was distributed in six states.
Siemens Healthcare Diagnostics is recalling IMMULITE PSA assays because they do not meet the high-dose hook effect expectations stated in the Instructions for Use.
Oscor, Inc. is recalling 26 units of the Adelante Breezeway 8F Straight sheath because a fragment of the inner liner detached during insertion. The defect poses a risk of foreign body introduction into the patient.
Navistar is recalling 2017 International ProStar, LoneStar, 9900i, and TranStar trucks because a battery latch may cause an electrical short and fire.
Brownwood Farms is recalling Jalapeno Cherry Butter because it contains Yellow #5, an ingredient not declared on the label.
Brownwood Farms is recalling Jalapeno Cherry Salsa because it contains Yellow 5, an ingredient not declared on the label.
Real Fudge is recalling Plain Fudge due to undeclared Blue #1 dye. The product was distributed in five states.
Real Fudge is recalling Rocky Road Fudge because it contains undeclared Blue #1 dye. The product was distributed in five states.
Sage Products LLC is recalling Comfort Shield Barrier Cream Cloths due to CGMP deviations and potential contamination on shared equipment.
Medtronic is voluntarily recalling specific lots of Affinity Fusion Oxygenators because of an out-of-specification condition involving additional plastic in the arterial sampling port.
Real Fudge is recalling Salted Caramel Fudge because the product contains undeclared Blue #1, a food dye.
Biomet 3i is recalling 50 units of Low Profile Abutments because some pouches may not have been sealed during packaging.
Teleflex Medical is recalling LMA MADett endotracheal tubes because they may fail to atomize medication, potentially causing inadequate anesthesia.
Teleflex Medical is recalling Flexi Nozzle Long sprayers because they may produce a straight stream instead of an atomized plume, potentially causing inadequate anesthesia.
Busse Hospital Disposables is recalling surgical instrument trays that contained recalled Covidien Devon Light Gloves.
Stryker is voluntarily recalling specific lots of sterile MIS Toolsteel Burs because they may exhibit signs of corrosion.
Biomet 3i is recalling 270 low-profile dental implant abutments because some pouches may not have been sealed during packaging.
Inventia Healthcare is recalling Duloxetine Delayed-Release Capsules 30 mg because capsule shells were found opening inside the bottles.
Stanmore Implants Worldwide Ltd. is recalling 15 femoral stem components because customer inquiries reported that the device stem punctured the packaging pouch.
Vygon MFG, Inc. is recalling 31,500 AMS-651 Microbore extension sets because the package displays an incorrect priming volume.
Stryker is voluntarily recalling specific lots of sterile MIS Toolsteel Burs because they may exhibit signs of corrosion.
Teleflex Medical is recalling RUSCH Pocket PAC Intermittent Catheter Kits because they are labeled with expiration dates that exceed the validated shelf life.
PerkinElmer is recalling 20ul Clear RoboRack Tips used with the JANUS Automated Workstation because they may dispense volumes 50-100% lower than specified.
Teleflex Medical is recalling LMA MADdy topical anesthesia sprays because they may produce a straight stream instead of an atomized plume, potentially causing inadequate anesthesia.
Owens & Minor is voluntarily recalling specific lots of Medi Choice Arm Slings due to surface contamination identified through customer complaints.
Biomet 3i is recalling 525 low-profile dental implant abutments because a limited number of product pouches may not have been sealed during packaging.
Stanmore Implants Worldwide Ltd. is recalling 15 units of DF Coated Integral Shaft & Stem components due to packaging punctures reported by customers.
Stanmore Implants Worldwide Ltd. is recalling 51 tibial components because the device stem may have punctured the sterile packaging.
Biomet 3i is recalling 150 dental implant abutments because a limited number of product pouches may not have been sealed during packaging.
Unilever is recalling Ben & Jerry's Brownie Batter Core Ice Cream because certain pints may contain soft plastic pieces.
AngioDynamics is recalling 162 boxes of Stiffened Micro-Introducer Kits because the rotating luer may detach from the dilator hub during use.
Stryker Howmedica Osteonics Corp. is recalling specific lots of GAM Kirschner Wires and T2 K-Wires because a manufacturing error may have compromised the sterile pouch seal.
Biomet 3i is recalling 101 units of a specific dental implant abutment because some product pouches may not have been sealed during packaging.
Stryker Instruments is voluntarily recalling specific lots of sterile MIS Toolsteel Burs because they may exhibit signs of corrosion.
Ultroid Technologies is recalling 7,784 sterile disposable probes because they were not manufactured under required quality system controls.
Synthes (USA) Products LLC is recalling 31 units of the VA Implant Rack for the Compact Distal Radius System because incorrect assembly could cause screws to touch the surface beneath the rack.
Real Fudge is recalling Nutty Fudge due to undeclared Blue #1 dye. The product was distributed in five states.
Teleflex Medical is recalling LMA MADomizer devices because they may produce a straight stream instead of an atomized plume, potentially causing inadequate anesthesia.
Brownwood Farms is recalling Apple Riesling Salsa because it contains Yellow 5, an ingredient not declared on the label.
Amendia, Inc. is recalling 25 Zeus-P Lumbar Interbody Devices because three boxes had conflicting patient and primary labels.
Stryker is voluntarily recalling specific lots of sterile MIS Toolsteel Burs because they may exhibit signs of corrosion.
Stanmore Implants Worldwide Ltd. is recalling 13 units of Tibial Component Fixed Hinge Small Long and Short due to punctured packaging.
Midwest International Corp is recalling dried vegetable products because they are acidified foods without a registered manufacturer or scheduled process.
Ortho-Clinical Diagnostics is recalling VITROS CRP Slides because the diluent contains endogenous CRP, which can cause falsely high test results if not subtracted.
Busse Hospital Disposables is recalling Breast Pack Surgical Instrument Trays because they contained gloves subject to a labeling update.
Biomet 3i is recalling a limited number of Low Profile 30-degree abutments because some product pouches may not have been sealed during packaging.
Philips is recalling nine Ingenia MR-OR units due to a possibility that patients or users may be exposed to a very small level of touch current.
Sage Products LLC is recalling 2% Chlorhexidine Gluconate Cloth due to CGMP deviations and potential contamination. The product was distributed nationwide and internationally.
Biomet 3i is recalling 53 units of Low Profile 17° Abutments because some pouches may not have been sealed during packaging.
Real Fudge is recalling 8 oz. Coconut Fudge containers due to undeclared Blue #1 dye. The product was distributed in five states.
Biomet 3i is recalling a limited number of dental implant abutments because some product pouches may not have been sealed during packaging.
Stryker is voluntarily recalling specific lots of sterile MIS Toolsteel Burs because they may exhibit signs of corrosion.
Stanmore Implants Worldwide Ltd. is recalling 11 femoral shaft components due to punctured packaging reported by customers.
Biomet 3i is recalling 108 dental implant abutments because some product pouches may not have been sealed during packaging.
Amendia, Inc. is recalling Savannah-T Straight Rods because some packages have unacceptable seals with compromised integrity.
Teleflex Medical is recalling Flexi Nozzle Short sprayers because they may deliver a straight stream instead of an atomized plume, potentially causing inadequate anesthesia.
Amendia, Inc. is recalling 1,078 Dual Stylet Needles because packaging seals are compromised by channels or voids, potentially affecting product integrity.
Teleflex Medical is recalling LMA MADgic atomization devices because they may produce a straight stream instead of an atomized plume, potentially causing inadequate anesthesia.
Busse Hospital Disposables is recalling Carpal Tunnel Packs because they contained Devon Light Gloves subject to a labeling update.
Biomet 3i is recalling 1,633 Low Profile Abutment Titanium Retaining Screws because a limited number of product pouches may not have been sealed during packaging.
Biomet 3i, LLC is recalling 160 units of Low Profile Abutments because some product pouches may not have been sealed during packaging.
Ultroid Technologies is recalling 62 mobile generator units and sterile probes because they were not manufactured under required quality system controls.
Stryker is voluntarily recalling specific lots of sterile MIS Toolsteel Burs because they may exhibit signs of corrosion.
Brownwood Farms is recalling Peach Salsa because it contains Yellow 5, a color additive not declared on the label.
Real Fudge is recalling 8 oz units of White Fudge because the product contains undeclared Blue #1 dye.
Biomet 3i is recalling 60 units of Low Profile Abutment Quickbridge because some product pouches may not have been sealed during packaging.
Biomet 3i is recalling 50 units of Low Profile Dental Implant Abutments because some product pouches may not have been sealed during packaging.
Hi-Tech Pharmacal is recalling Rx CHOICE brand Liquid Vitamin C because the active ingredient is at a lower level than stated on the label.
Biomet 3i is recalling 1,371 low profile abutments because a limited number of product pouches may not have been sealed during packaging.
Biomet 3i is recalling 735 low profile dental abutments because a limited number of product pouches may not have been sealed during packaging.
Biomet 3i is recalling 127 dental implant abutments because some product pouches may not have been sealed during packaging.
Amendia, Inc. is recalling 5,833 units of K-Wires because the packaging seals are unacceptable, with some showing compromised integrity due to channels or voids.
Biomet 3i is recalling 108 low profile abutments because some pouches may not have been sealed during packaging.
Biomet 3i is recalling specific low-profile dental implant abutments because a limited number of product pouches may not have been sealed during packaging.
PerkinElmer Health Sciences is recalling 79 DELFIA hFSH kits because real-time stability testing showed decreased hFSH concentrations in control sera.
Biomet 3i is recalling 46 units of a specific dental implant abutment because some product pouches may not have been sealed during packaging.
Biomet 3i is recalling 458 low profile abutment impression copings because a limited number of product pouches may not have been sealed during packaging.
Biomet 3i is recalling 27 specific dental implant abutments because some product pouches may not have been sealed during packaging.
Biomet 3i is recalling 191 Low Profile Abutment units because some pouches may not have been sealed during packaging.
Les Emballages Knowlton Inc. is recalling Tom's of Maine Naturally Dry Natural Powder Antiperspirant Stick because an incorrect back label was applied to the product.
Biomet 3i is recalling 123 units of Low Profile Dental Abutments because some product pouches may not have been sealed during packaging.
Biomet 3i is recalling 64 dental implant abutments because some product pouches may not have been sealed during packaging.
PerkinElmer is recalling 73 EnLite Neonatal TREC Kits because the Unique Device Identifier (UDI) is missing from the outer box labels.
Biomet 3i is recalling 246 dental implant abutments because a limited number of product pouches may not have been sealed during packaging.
Hi-Tech Pharmacal is recalling Rx CHOICE brand Liquid Vitamin C because the product failed to meet pH specifications.
OrthoPediatrics is recalling 22 PediNail Intramedullary Nailing System 4.5mm X 48mm Cortical Screws because they measure 50mm instead of the labeled 48mm.
Biomet 3i is recalling 391 Low Profile Abutment Healing Caps because a limited number of product pouches may not have been sealed during packaging.
Biomet 3i is recalling 28 dental implant abutments because some product pouches may not have been sealed during packaging.
Biomet 3i is recalling 228 dental implant abutments because a limited number of product pouches may not have been sealed during packaging.
Biomet 3i is recalling 124 dental implant abutments because some product pouches may not have been sealed during packaging.
Biomet 3i is recalling 137 dental implant abutments because some product pouches may not have been sealed during packaging.
Biomet 3i is recalling 108 dental implant abutments because some product pouches may not have been sealed during packaging.
Biomet 3i is recalling 191 dental implant abutments because some product pouches may not have been sealed during packaging.
Biomet 3i is recalling 216 dental implant abutments because some product pouches may not have been sealed during packaging.
Biomet 3i is recalling 175 dental implant abutments because some product pouches may not have been sealed during packaging.
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