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Browse Device Recalls

3,013 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,013 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Medical Device Recalls

Browse 3,013 FDA device recalls in 2018.

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DateProductReasonClassFirm
Aug 13, 2018 CHS Custom Convenience Kit-SURGICAL GOWN, LARGE SET IN SLEEVES Product Numb... Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromisi... Class II Custom Healthcare Systems, Inc.
Aug 13, 2018 remel THIOGLYCOLLATE MEDIUM W/O INDICATOR. W/ DEXTROSE (a) 9ML, REF 064700 ... Products have intermittently failed performance testing during stability studies with various ana... Class II Remel Inc
Aug 13, 2018 CHS Custom Convenience Kit-CONNECTOR PACK Product Number:D36-7520 Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromisi... Class II Custom Healthcare Systems, Inc.
Aug 13, 2018 CHS Custom Convenience Kit- UNC-VIR TRAY Product Number:UNC-17914 Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromisi... Class II Custom Healthcare Systems, Inc.
Aug 13, 2018 CHS Custom Convenience Kit-PAD, COTTON SINGLE Product Number:R1178 Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromisi... Class II Custom Healthcare Systems, Inc.
Aug 13, 2018 CHS Custom Convenience Kit-INJECTION TRAY Product Number: B9-17201 Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromisi... Class II Custom Healthcare Systems, Inc.
Aug 13, 2018 CHS Custom Convenience Kit-TOENAIL REMOVAL TRAY Product Number: (1) ZZ-0956... Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromisi... Class II Custom Healthcare Systems, Inc.
Aug 13, 2018 CHS Custom Convenience Kit- (1) DT SCATPAD, DBL. TAPE, 12.5 X 16.5 Produ... Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromisi... Class II Custom Healthcare Systems, Inc.
Aug 13, 2018 CHS Custom Convenience Kit-LP NEEDLE, 22G X 1 Product Number:NC401000 Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromisi... Class II Custom Healthcare Systems, Inc.
Aug 13, 2018 CHS Custom Convenience Kit-SPECIALIST¿ CAST PADDING 3" X 4 YDS) Product Num... Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromisi... Class II Custom Healthcare Systems, Inc.
Aug 13, 2018 CHS Custom Convenience Kit-ROCHESTER PEAN, CURVED (8") Product Number:D36-16669 Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromisi... Class II Custom Healthcare Systems, Inc.
Aug 13, 2018 remel THIOGLYCOLLATE MEDIUM, REF 05152 Products have intermittently failed performance testing during stability studies with various ana... Class II Remel Inc
Aug 13, 2018 CHS Custom Convenience Kit-MOSQUITO FORCEPS 5 STR Product Number:B9-18914 Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromisi... Class II Custom Healthcare Systems, Inc.
Aug 13, 2018 CHS Custom Convenience Kit- COBAN¿, LF (1"X5 YDS) Product Number:D5-14591 Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromisi... Class II Custom Healthcare Systems, Inc.
Aug 13, 2018 CHS Custom Convenience Kit-GENERAL UTILITY TRAY Product Number:S1528-02 Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromisi... Class II Custom Healthcare Systems, Inc.
Aug 13, 2018 CHS Custom Convenience Kit-SUTURE REMOVAL KIT (W.ADSON SERR)Product Number:UN... Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromisi... Class II Custom Healthcare Systems, Inc.
Aug 13, 2018 CHS Custom Convenience (1) 1231-150L GOWN, RAGLAN, LG, NONREINF (2) 1231-... Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromisi... Class II Custom Healthcare Systems, Inc.
Aug 13, 2018 CHS Custom Convenience Kit-FENESTRATED DRAPE 40 X 62P Part Number: 1222-2112 Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromisi... Class II Custom Healthcare Systems, Inc.
Aug 13, 2018 CHS Custom Convenience Kit- LITTLE SNIPPER CIRCUMCISION TRAY Part Number: Y... Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromisi... Class II Custom Healthcare Systems, Inc.
Aug 13, 2018 IsoFlex LAL Support Surface, Model Number 2860 Product Usage: : The Is... Certain 2860 IsoFlex LAL support surfaces were assembled with a non-conforming fire barrier. Class II Stryker Medical Division of Stryker Corporation
Aug 13, 2018 VITEK(R) 2 AST-P640, For susceptibility testing of Staphylococcus spp. Entero... Routine internal review of Device History Records identified six VITEK(R) 2 AST card lots were ma... Class II bioMerieux, Inc.
Aug 13, 2018 CHS Custom Convenience Kit-TOOTHBRUSH, 46 TUFT Product Number:R1635 Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromisi... Class II Custom Healthcare Systems, Inc.
Aug 13, 2018 CHS Custom Convenience Kit-WEBSTER NEEDLE HOLDER Product Number:01-375C Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromisi... Class II Custom Healthcare Systems, Inc.
Aug 13, 2018 CHS Custom Convenience Kit- PENROSE DRAIN (.75" X 18") Product Number:D8-9425B Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromisi... Class II Custom Healthcare Systems, Inc.
Aug 13, 2018 CHS Custom Convenience Kit-SUTURE REMOVAL KIT #1 Product Number: -ZZ-0664 Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromisi... Class II Custom Healthcare Systems, Inc.
Aug 13, 2018 AVS Aria Cage, Catalog Number 48753212 Product Usage: The Stryker Spine A... The anterior and posterior markers on the cage were on the incorrect/opposite sides of the cage. Class II Stryker Spine
Aug 13, 2018 VITEK(R) 2 AST-P655, For susceptibility testing of Staphylococcus spp. Entero... Routine internal review of Device History Records identified six VITEK(R) 2 AST card lots were ma... Class II bioMerieux, Inc.
Aug 13, 2018 CHS Custom Convenience Kit-COTTON TIP APPLICATORS, 10'S (6") Product Number... Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromisi... Class II Custom Healthcare Systems, Inc.
Aug 13, 2018 CHS Custom Convenience Kit-BONE MARROW TRAY Product Number:B9-4000 Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromisi... Class II Custom Healthcare Systems, Inc.
Aug 13, 2018 CHS Custom Convenience Kit-FOERSTER SPONGE FORCEPS, SERR, ST (9.5 ) Product... Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromisi... Class II Custom Healthcare Systems, Inc.
Aug 12, 2018 VaccZyme Human Anti-Haemophilus influenza type b Enzyme Immunoassay Kit For i... A deterioration of performance was identified with influenza type B Enzyme Immunoassay Kits with ... Class II The Binding Site Group, Ltd.
Aug 10, 2018 ev3 TurboHawk PERPHERAL PLAQUE EXCISION SYSTEM FOR SURGICAL USE, LARGE VESSEL... The Distal Flush Tool (DFT) accessories that were packaged in this lot number are not compatible ... Class II Micro Therapeutics Inc, Dba Ev3 Neurovascular
Aug 10, 2018 Disposable Smooth Interior Tubing Material: Polyethylene EVA copolymer. Thi... Some of the Disposable Smooth Interior Tubing may pull apart when stretched. Class II A M Systems Inc
Aug 10, 2018 Pointe Scientific AutoHDL/LDL Cholesterol Calibrator, Catalog Number H7545-CA... Vials of the autoHDL/LDL Calibrator were shipped without a vial label. Class III Medtest Holdings, Inc.
Aug 9, 2018 HipLOC Hip Fracture Fixation System-Hiploc System 135¿ Plate 38 mm Barrel 4 H... HipLOC System Plate Barrel due to an undersized bore on the HipLOC plate barrel, can result in th... Class II Biomet UK Ltd.
Aug 9, 2018 C-flex 570C +19.0D Intraocular Lens Product Usage: C-flex IOLs are designe... Firm become aware of reports of post-operative refractive errors following implantation of lenses. Class II Rayner Intraocular Lenses Limited
Aug 9, 2018 Ambu Aura40 Standard, Reusable Laryngeal Mask Catalog Number: 340300000 Ambu Aura40 Standard, Reusable Laryngeal Mask packaged in a pouch marked AuraStraight Silicone, ... Class II Besmed Health Business Corporation
Aug 9, 2018 HipLOC Hip Fracture Fixation System- Hiploc System 130¿ Plate 38 mm Barrel 4 ... HipLOC System Plate Barrel due to an undersized bore on the HipLOC plate barrel, can result in th... Class II Biomet UK Ltd.
Aug 9, 2018 HipLOC Hip Fracture Fixation System-Hiploc System 140¿ Plate 38 mm Barrel 4 H... HipLOC System Plate Barrel due to an undersized bore on the HipLOC plate barrel, can result in th... Class II Biomet UK Ltd.
Aug 9, 2018 HipLOC Hip Fracture Fixation System-Hiploc System 135¿ Plate 38 mm Barrel 3 H... HipLOC System Plate Barrel due to an undersized bore on the HipLOC plate barrel, can result in th... Class II Biomet UK Ltd.
Aug 8, 2018 Extra corporeal circuit with bio-active surface. Affected products failed a sterilization test. Class II Medtronic Perfusion Systems
Aug 8, 2018 Affixus Hip Fracture Nail Right 125 13 mm x 360 mm, Item Number 814313360 ... There were complaints indicating that when the product was opened in surgery, the sterile packagi... Class II Zimmer Biomet, Inc.
Aug 8, 2018 Magellan LeadCare¿ II Blood Lead Test Kit. In Vitro Test for the measurement ... Defect with the calibration button for lot 1808M. Level 1 and Level 2 Quality Control (QC) values... Class II Magellan Diagnostics, Inc.
Aug 8, 2018 Affixus Hip Fracture Nail Left 125 9 mm x 320 mm, Item Number 814409320 Prod... There were complaints indicating that when the product was opened in surgery, the sterile packagi... Class II Zimmer Biomet, Inc.
Aug 8, 2018 Affixus Hip Fracture Nail 125 9 mm x 165 mm, Item Number 816709165 Product... There were complaints indicating that when the product was opened in surgery, the sterile packagi... Class II Zimmer Biomet, Inc.
Aug 8, 2018 Bronchovideoscope BF-3C160 The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have ... Class II Olympus Corporation of the Americas
Aug 8, 2018 Affixus Hip Fracture Nail Right 125 13 mm x 300 mm, Item Number 814313300 ... There were complaints indicating that when the product was opened in surgery, the sterile packagi... Class II Zimmer Biomet, Inc.
Aug 8, 2018 Affixus Hip Fracture Nail Left 130 9 mm x 360 mm, Item Number 814609360 ... There were complaints indicating that when the product was opened in surgery, the sterile packagi... Class II Zimmer Biomet, Inc.
Aug 8, 2018 Affixus Hip Fracture Nail Right 125 9 mm x 300 mm, Item Number 814309300 P... There were complaints indicating that when the product was opened in surgery, the sterile packagi... Class II Zimmer Biomet, Inc.
Aug 8, 2018 Bronchovideoscope BF-P160 The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have ... Class II Olympus Corporation of the Americas

Frequently Asked Questions

When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.

All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.

Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.