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Vehicle Recalls320,000+ NHTSA safety recalls Browse VehiclesEvery make, model and year Complaints2.1M+ consumer safety complaints TSBs4.7M technical service bulletins VIN LookupDecode any vehicle VIN instantly OBD Codes12,000+ diagnostic trouble codes Fuel EconomyEPA MPG data for all vehicles Safety Ratings11,700+ NHTSA crash test ratings Investigations5,300+ NHTSA defect investigations StatisticsRecall trends & safety analysis Compare VehiclesTwo vehicles side by side

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Product Safety9,700+ CPSC product recalls Food Safety28,600+ FDA food recalls Pet Safety1.3M FDA animal adverse events Drug Safety17,500+ FDA drug recalls Device Safety38,400+ FDA device recalls Workplace Safety102,900+ OSHA injury reports Brand HistoryRecall lookup by company

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Browse Device Recalls

3,191 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,191 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 3,191 FDA device recalls.

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DateProductReasonClassFirm
Jan 21, 2016 Stryker, T2 Guidewire, Ball-Tipped, 3x800 mm Product Usage: Intended for ... During a review of the packaging, it was determined that the seal integrity of the pouch may be d... Class II Stryker Howmedica Osteonics Corp.
Jan 21, 2016 Stryker, T2 Guidewire, Ball Tipped, 3 x 1250mm Product Usage: Intended fo... During a review of the packaging, it was determined that the seal integrity of the pouch may be d... Class II Stryker Howmedica Osteonics Corp.
Jan 21, 2016 Stryker, T2 Guidewire, Ball-Tipped, 2.5 x 1000mm Product Usage: Intended ... During a review of the packaging, it was determined that the seal integrity of the pouch may be d... Class II Stryker Howmedica Osteonics Corp.
Jan 21, 2016 Stryker, T2 Fixation K-Wire 3 x 285mm WCH coated Product Usage: Intended ... During a review of the packaging, it was determined that the seal integrity of the pouch may be d... Class II Stryker Howmedica Osteonics Corp.
Jan 21, 2016 Stryker, T2 Guidewire, Ball-Tipped, 3 x 1000mm Product Usage: Intended fo... During a review of the packaging, it was determined that the seal integrity of the pouch may be d... Class II Stryker Howmedica Osteonics Corp.
Jan 21, 2016 Stryker, Gamma3 K-Wire with Washer, 13x3.2x500 mm Product Usage: Intended... During a review of the packaging, it was determined that the seal integrity of the pouch may be d... Class II Stryker Howmedica Osteonics Corp.
Jan 21, 2016 Stryker, T2 Guidewire, Smooth-Tipped, 3 x 800mm Product Usage: Intended f... During a review of the packaging, it was determined that the seal integrity of the pouch may be d... Class II Stryker Howmedica Osteonics Corp.
Jan 20, 2016 Flexor Check-Flo Introducer, Catheter introducer, Catalog #: KCFW-6.0-35-70... Incorrect packaging. Reports of packages labeled as 6.0Fr actually containing 5.0Fr devices. Class II Cook Inc.
Jan 15, 2016 Restoris Multicompartmental Knee (MCK) System RESTORIS MCK is indicated fo... Reports where the Mylar/Tyvek pouch for RESTORIS MCK Baseplate in the clamshell packaging configu... Class II Mako Surgical Corporation
Jan 14, 2016 9131-001 Defibrillation Electrodes, Lot No. 141125-02 Used in Powerheart G3 ... Defibrillation electrodes may increase electrical impedance over time. If impedance becomes too h... Class II Cardiac Science Corporation
Jan 12, 2016 Super Arrow-Flex Percutaneous Sheath Introducer Sets REF CL-07035 or CL-07... Arrow has issued a recall for these products due to potential packaging damage. The sterility of ... Class II Arrow International Inc
Dec 21, 2015 Baxter, RAPIDFILL Syringe Strip, 10 ml. For use with RAPIDFILL Automated Syr... All lots of RAPIDFILL Syringe Strips lack evidence supporting the packaging claim for 12-month sh... Class II Baxter Corporation Englewood
Nov 30, 2015 Columbus Revision Knee System, EnduRo Knee System Product Usage: The Colu... Aesculap Inc. US has initiated a recall on Tibial and Femur extension sterile pressfit stem impla... Class II Aesculap, Inc.
Nov 17, 2015 MediChoice Cohesive Bandages, One (1) roll of cohesive bandage per bag, thirt... MediChoice sterile cohesive bandages imported and sold under a private brand by Owens & Minor wer... Class II Owens & Minor Distribution, Inc.
Nov 17, 2015 MediChoice Cohesive Bandages, One (1) roll of cohesive bandage per bag, thirt... MediChoice sterile cohesive bandages imported and sold under a private brand by Owens & Minor wer... Class II Owens & Minor Distribution, Inc.
Nov 17, 2015 MediChoice Cohesive Bandages, One (1) roll of cohesive bandage per bag, thirt... MediChoice sterile cohesive bandages imported and sold under a private brand by Owens & Minor wer... Class II Owens & Minor Distribution, Inc.
Nov 2, 2015 AMS 4674 Custom Pack. For use in a general clinical procedure. AMS 4674 Custom Pack is recalled because this kit containing U-SDN 2 Part Ultra Modified Seldinge... Class II Windstone Medical Packaging, Inc.
Nov 2, 2015 AMS 4675 Angio Pack. For use in a general clinical procedure. AMS 4675 Angio Pack is recalled because this kit containing U-SDN 2 Part Ultra Modified Seldinger... Class II Windstone Medical Packaging, Inc.
Oct 30, 2015 RBT, Internal Implant, Laser-Lok, 5.0 x 15mm, 5.7 Platform, REF LPBR5015, Rx ... An incorrect label reading 10.5mm and not the specified 15mm was placed on the implant inner ... Class II BioHorizons Implant Systems Inc
Oct 21, 2015 LeMaitre Over-the-Wire Embolectomy Catheter 3F, 40cm, Model 1651-34 and e1651... Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead... Class II LeMaitre Vascular, Inc.
Oct 21, 2015 LeMaitre Over-the-Wire Embolectomy Catheter 7F, 80cm, Model 1654-78 and e1654... Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead... Class II LeMaitre Vascular, Inc.
Oct 21, 2015 LeMaitre Single Lumen Embolectomy Catheter 5F, 80 cm, Model 1601-58 and e1601... Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead... Class II LeMaitre Vascular, Inc.
Oct 21, 2015 LeMaitre Over-the-Wire Embolectomy Catheter 5F Plus, 40 cm, Model e1651-84. ... Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead... Class II LeMaitre Vascular, Inc.
Oct 21, 2015 LeMaitre Over-the-Wire Embolectomy Catheter 6F, 80 cm, Model e-1651-68. In... Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead... Class II LeMaitre Vascular, Inc.
Oct 21, 2015 LeMaitre Over-the-Wire Embolectomy Catheter 5F Plus, 80cm, Model 1651-88 and ... Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead... Class II LeMaitre Vascular, Inc.
Oct 21, 2015 LeMaitre NovaSil Silicone Single Lumen Embolectomy Catheter 2F, 60 cm, Model ... Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead... Class II LeMaitre Vascular, Inc.
Oct 21, 2015 LeMaitre Single Lumen Embolectomy Catheter 3F, 80 cm, Model 1601-38 and e1601... Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead... Class II LeMaitre Vascular, Inc.
Oct 21, 2015 LeMaitre Over-the-Wire Embolectomy Catheter 4F, 80cm, Model 1651-48 and e1654... Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead... Class II LeMaitre Vascular, Inc.
Oct 21, 2015 LeMaitre Single Lumen Embolectomy Catheter 4F, 80 cm, Model 1601-48 and e1601... Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead... Class II LeMaitre Vascular, Inc.
Oct 21, 2015 LeMaitre NovaSil Silicone Single Lumen Embolectomy Catheter 6F, 80 cm, Model ... Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead... Class II LeMaitre Vascular, Inc.
Oct 21, 2015 LeMaitre Over-the-Wire Embolectomy Catheter 3F, 80cm, Model 1651-38. Indicat... Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead... Class II LeMaitre Vascular, Inc.
Oct 21, 2015 LeMaitre Over-the-Wire Embolectomy Catheter 6F, 40 cm, Model e-1651-64. Indi... Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead... Class II LeMaitre Vascular, Inc.
Oct 14, 2015 SSS Reprocessed Zimmer, Synthes, Stryker and Linvatec Drill Bits and Blades ... It was reported that packaging was not properly sealed. Class II Stryker Sustainability Solutions
Sep 29, 2015 MaxAn 4.0mm and 4.5mm fixed screws, used in the MaxAn Anterior Cervical Plate... The packaging of 4.5 mm diameter MaxAn screws identifies/labels the screws as 4.0 mm diameter scr... Class II Biomet Spine, LLC
Sep 28, 2015 Exactech Acapella One Interbody Fusion Device Parallel. Orthopedic Spinal Su... Incorrect external and internal packaging labels. Exactech has identified nineteen (19) Acapella ... Class II Exactech, Inc.
Sep 23, 2015 HARMONIC ACE+ 7 Laparoscopic Shears with Advanced Hemostasis (23cm, 36cm, 45c... Complaints of holes in Tyvek which can compromise the sterile barrier provided by the packaging. Class II Ethicon Endo-Surgery Inc
Sep 21, 2015 Stryker Orthopaedics Duracon Flat Tibial Wedge Cemented use only Sterile. Tib... Stryker Orthopaedics has received two customer complaints regarding Duracon Tibial Wedge implants... Class II Stryker Howmedica Osteonics Corp.
Sep 14, 2015 MILEX PESSARY KIT; Model Numbers: MXPES00; MXKPES00; MXKPREG03; MXKPGSK07 ... The products have been identified to have incorrect size prints on the MILEX PESSARY KIT packagin... Class III CooperSurgical, Inc.
Sep 10, 2015 Smith & Nephew MOSAICPLASTY DP- Disposable Harvesting System 8.5 mm, Sterile ... Sterility of device is compromised due to breach in the packaging Class II Smith & Nephew, Inc., Endoscopy Div.
Sep 10, 2015 DeRoyal sterile custom surgical kits: 1) Emergency CABG Pack Pgybk, ref 89-7... These custom sterile surgical kits contain the component, ECOLAB ORS Fluid Warming and Slush Drap... Class II DeRoyal Industries Inc
Sep 10, 2015 Smith & Nephew MOSAICPLASTY DP- Disposable Harvesting System 6.5 mm, Sterile ... Sterility of device is compromised due to breach in the packaging Class II Smith & Nephew, Inc., Endoscopy Div.
Sep 10, 2015 Smith & Nephew MOSAICPLASTY DP- Disposable Harvesting System 4.5 mm, Sterile ... Sterility of device is compromised due to breach in the packaging Class II Smith & Nephew, Inc., Endoscopy Div.
Sep 10, 2015 Smith & Nephew MOSAICPLASTY DP- Disposable Harvesting System 3.5 mm, Sterile ... Sterility of device is compromised due to breach in the packaging Class II Smith & Nephew, Inc., Endoscopy Div.
Sep 9, 2015 Fluorescence Imaging Procedure Kits used with the da Vinci Si and Xi Surgical... B. Braun 2 gang 4-way stopcocks in the Fluorescence Imaging Procedure Kit may experience damage ... Class II Intuitive Surgical, Inc.
Sep 3, 2015 Zimmer Natural Nail CM Long. Intramedullary Fixation Rod. The Zimmer Na... In about 5% of tested samples, the outer tray was found to be compromised. Risks: A damaged oute... Class II Zimmer Gmbh
Aug 31, 2015 MATResponder Tourniquet; Catalog number MATR: UPC 78353 00008; MATCombat Tou... Once tested, it is required that the tourniquet be returned to its Ready position then placed in ... Class II Pyng Medical Corporation
Aug 24, 2015 Zimmer, Reprocessed Zimmer Tourniquet Cuffs,34" Single Hose Single Bladder Br... Sterilmed, Inc. is recalling its reprocessed Zimmer Tourniquet Cuff, Part #ZIM60-7075-106, lot nu... Class II STERILMED, INC.
Aug 24, 2015 Magic3 Intermittent Catheter with Sure Grip Hydrophilic Coated Silicone Coude... Potential breach of the sterile barrier packaging. Class II C.R. Bard, Inc.
Aug 20, 2015 Aliquot Delivery Kit (Syringe and Plunger); for use in open and percutaneous ... Two isolated instances of holes in the outer header bag component of the double barrier sterile p... Class II Orthovita, Inc., dBA Stryker Orthobiologics.
Aug 18, 2015 Microtek Medical, Inc. ORS Fluid Warming and Slush Drapes, Model #'s ORS-10... The sterile packaging may contain small (less than 250 microns wide) channels in the seal of the ... Class II Ecolab Inc

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.