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Vehicle Safety

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

Consumer Safety

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

3,264 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,264 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 3,264 FDA device recalls.

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DateProductReasonClassFirm
Mar 10, 2016 HIgH-Flo Subcutaneous Safety Needle Sets, 2-Needle Set/ 24 Gauge 9mm Needles,... On 2/24/2016 during post sterilization inspection of part number F180 Precision Flow Rate Tubing,... Class II Repro-Med Systems, Inc.
Mar 10, 2016 Freedom60 Precision Flow Rate Tubing Sets, REF/Part Numbers F900, F2400, F60,... On 2/24/2016 during post sterilization inspection of part number F180 Precision Flow Rate Tubing,... Class II Repro-Med Systems, Inc.
Feb 18, 2016 Oblique Posterior Atraumatic Lumbar (OPAL) System, Polymeric spinal fusion ca... The label on the outer packaging does not match the product inside and intended use of the device. Class II Synthes (USA) Products LLC
Feb 11, 2016 M/L Taper Hip Prosthesis (Item: 00-7711-012-20, Lot: 62937093 Zimmer Biomet initiated a lot-specific voluntary recall on 02/11/2016, of the M/L Taper Hip Prost... Class II Zimmer Biomet, Inc.
Feb 4, 2016 Bard TruGuide Disposable Coaxial Biopsy Needle Product Usage: The TruGuid... Bard Peripheral Vascular, Inc. is recalling Bard TruGuide Disposable Coaxial Biopsy Needles becau... Class II Bard Peripheral Vascular Inc
Feb 4, 2016 50001 (Inrad) AccuPlace Drace Stereotaxic Needle Guide; Assists the user wit... During an evaluation of the product packaging, it was determined that there is a potential for th... Class II Stryker Instruments Div. of Stryker Corporation
Feb 4, 2016 50000 (Inrad) AccuPlace Drace Stereotaxic Needle Guide; Assists the user wit... During an evaluation of the product packaging, it was determined that there is a potential for th... Class II Stryker Instruments Div. of Stryker Corporation
Feb 4, 2016 (Stryker) AccuPlace Straight Level Needle Guide; Assists the user with insert... During an evaluation of the product packaging, it was determined that there is a potential for th... Class II Stryker Instruments Div. of Stryker Corporation
Feb 4, 2016 (Stryker) AccuPlace Round Level Needle Guide; Assists the user with inserting... During an evaluation of the product packaging, it was determined that there is a potential for th... Class II Stryker Instruments Div. of Stryker Corporation
Jan 29, 2016 Trinity Acetabular Shell Product Usage: Total Hip Replacement. Potential for abrasion of the sterile barrier pouches of the new packaging system. Class II Corin USA Limited
Jan 29, 2016 Trinity Acetabular Shell Product Usage Total Hip Replacement. Potential for abrasion of the sterile barrier pouches of the new packaging system. Class II Corin USA Limited
Jan 29, 2016 Trinity Acetabular System Product Usage - Total Hip Replacement. Potential for abrasion of the sterile barrier pouches of the new packaging system. Class II Corin USA Limited
Jan 21, 2016 Stryker, T2 K-Wire with washer, 7.8 x 3 x 285mm 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 21, 2016 Stryker, Gamma K-Wire 3.2x450 mm Product Usage: Intended for the temporar... 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, Gamma K-Wire 3.2x450 mm, UNS-Thread 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, METAIZEAU Intramedullary Pin, 2.0 x 400 mm Product Usage: Intend... 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 K-Wire, 3.2x400mm, Recon Product Usage: Intended for the temp... 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, 2.5x800 mm 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, Smooth-Tipped, 2.2 x 800mm 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 K-Wire, 3x285 mm Product Usage: Intended for the temporary st... 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, Gamma Guide Pin, 4x400 mm Product Usage: Intended for the tempor... 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 K-Wire 1.8 x 310 mm, Sterile Product Usage: Intended for the ... 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 K-Wire, 3.2x400mm, CoCr, Recon Product Usage: Intended for th... 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, 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.

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.