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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

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

3,179 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,179 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 3,179 FDA device recalls.

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DateProductReasonClassFirm
Jul 22, 2013 Contra-Angle Torque Driver Kit For Certain and External Connection Product... During recent revised sterilization validation testing, the included surgical trays did not meet ... Class II Biomet 3i, LLC
Jul 22, 2013 Contra-Angle Torque Driver Kit For Certain Internal Connection Product Usa... During recent revised sterilization validation testing, the included surgical trays did not meet ... Class II Biomet 3i, LLC
Jul 22, 2013 Contra-Angle Torque Driver Kit Product Usage: Molded plastic tray used in... During recent revised sterilization validation testing, the included surgical trays did not meet ... Class II Biomet 3i, LLC
Jul 22, 2013 Navigator Surgical Kit Product Usage: Molded plastic tray used in holding... During recent revised sterilization validation testing, the included surgical trays did not meet ... Class II Biomet 3i, LLC
Jul 22, 2013 Tapered Navigator Certain Surgical Kit Product Usage: Molded plastic tray... During recent revised sterilization validation testing, the included surgical trays did not meet ... Class II Biomet 3i, LLC
Jul 18, 2013 Distributed in USA: Product Number: 40-2894: Reinforced Wound Closure, Late... Aspen Surgical is recalling Wound Closures because firm could not confirm sterility, after FDA sa... Class II Aspen Surgical Products, Inc.
Jun 24, 2013 SC2316, Distal Femoral Augment with Screw Total knee replacement due to os... The firm became aware of an incident relating to a breach of sterility in the sterility barrier p... Class II Stelkast Co
Jun 19, 2013 VERSA-FX FEMORAL FIXATION SYSTEM COMPRESSION LAG SCREW, several length (55 m... Single packaging configuration used for the VERSA-FX-II Femoral Fixation System failed the leak t... Class II Zimmer, Inc.
Jun 19, 2013 VERSA-FX II FEMORAL FIXATION SYSTEM COMPRESSION TUBE/PLATE, standard and shor... Single packaging configuration used for the VERSA-FX-II Femoral Fixation System failed the leak t... Class II Zimmer, Inc.
Jun 19, 2013 Free Lock Femoral Hip Fixation System Compression Tube/Plate, different lengt... Single packaging configuration used for the VERSA-FX-II Femoral Fixation System failed the leak t... Class II Zimmer, Inc.
Jun 19, 2013 Free Lock Femoral Hip Fixation System Compression Lag Screw . Several lengths... Single packaging configuration used for the VERSA-FX-II Femoral Fixation System failed the leak t... Class II Zimmer, Inc.
Jun 19, 2013 VERSA-FX II FEMORAL FIXATION SYSTEM COMPRESSION TUBE/PLATE, standard and shor... Single packaging configuration used for the VERSA-FX-II Femoral Fixation System failed the leak t... Class II Zimmer, Inc.
May 31, 2013 27023WU Balloon Catheter, 3 Fr., 2/pkg, sterile, contains latex. The RUS... Karl Storz Endoscopy-America has initiated the recall of the 27023WU Balloon Catheter because the... Class II Karl Storz Endoscopy America Inc
May 24, 2013 GYRUS ACMI, MYRINGOTOMY KNIFE DISPOSABLE, SICKLE BLADE FLAT HANDLE, REF 13071... lack of sterility assurance Class II Gyrus Acmi, Incorporated
May 6, 2013 Anspach MIA 16 (16cm Minimally Invasive Attachment), Rx Only MIA16 attachm... Product did not reach expected sterility assurance level Class II The Anspach Effort, Inc.
Apr 30, 2013 FAST Procedure Kit. Intended for use as a Minor Surgical Procedures Tray. American Optisurgical, Inc initiated a recall of ChloraPrep Hi-Lite Orange 3mL Applicator, in re... Class II American Optisurgical Inc
Apr 8, 2013 Endopath Electrosurgery Probe Plus II, twelve (12) different devices, includi... The firm is recalling the ENDOPATH Probe Plus II Shafts because the possibility that a tear in th... Class II Ethicon Endo-Surgery Inc
Mar 22, 2013 LHB, First Aid Type I Individual Kit, NSN: 6545-00-656-1092, antiseptics, Kit... The product contains an iodine 10% Ampule (10% Povidone Iodine swab) which is being recalled by t... Class III Lighthouse For The Blind
Mar 22, 2013 LHB, Perishable Item Pack Type III. Kit number: 2114011-100. First Aid Kit. The product contains an iodine 10% Ampule (10% Povidone Iodine swab) which is being recalled by t... Class III Lighthouse For The Blind
Mar 22, 2013 LHB, Perishable Items Pack Type IV. Kit number: 2114016-100. First Aid Kit. The product contains an iodine 10% Ampule (10% Povidone Iodine swab) which is being recalled by t... Class III Lighthouse For The Blind
Mar 22, 2013 LHB, Perishable Items Pack Type I , Kit Number: 2114002-100. First Aid ... The product contains an iodine 10% Ampule (10% Povidone Iodine swab) which is being recalled by t... Class III Lighthouse For The Blind
Mar 22, 2013 LHB, Type I First Aid Kit Perishable, Non-Aspirin 4/pg, Aspirin 4/pg and Povi... The product contains an iodine 10% Ampule (10% Povidone Iodine swab) which is being recalled by t... Class III Lighthouse For The Blind
Mar 22, 2013 LHB, First Aid Type IV Belt Type, NSN #6545-01-010-7754. Kit number: 114016... The product contains an iodine 10% Ampule (10% Povidone Iodine swab) which is being recalled by t... Class III Lighthouse For The Blind
Mar 22, 2013 LHB, Antiseptic Kit, Povidone Swab, Gauze Pads, and non-stick pads. Kit Numb... The product contains an iodine 10% Ampule (10% Povidone Iodine swab) which is being recalled by t... Class III Lighthouse For The Blind
Mar 22, 2013 LHB, First Aid Type III, NSN # 6545-00-656-1094, Kit number: 2114011. Fi... The product contains an iodine 10% Ampule (10% Povidone Iodine swab) which is being recalled by t... Class III Lighthouse For The Blind
Mar 18, 2013 LeMaitre Stent Guide: 1102-00 (100 strips); 1102-50 (50 strips); 1102-20 (20 ... Devices were not sealed correctly during the manufacturing process, and the sterility of these pr... Class II LeMaitre Vascular, Inc.
Mar 18, 2013 Glow 'N Tell 20 cm Tape: 1100-00 (100 strips); 1100-50 (50 strips); 1100-20 ... Devices were not sealed correctly during the manufacturing process, and the sterility of these pr... Class II LeMaitre Vascular, Inc.
Mar 14, 2013 Edwards Lifesciences Duraflo coated Femoral Cannula. Product Usage: T... Two unsealed pouches were found at an Edwards' distribution location in Japan. Incorrectly seale... Class II Edwards Lifesciences, LLC
Mar 4, 2013 Sepp, Compound Benzoin Tincture Packaged and Tincture 3,000 Bulk. Product... An internal review of CareFusion's labeling for preoperative skin prep product codes was recently... Class III CareFusion 213, LLC
Feb 8, 2013 Zimmer NexPosure, retractor portals of the NexPosure MIS Access System, Part ... Possibility that the inner pouch may be compromised. The product is packaged in two pouches - a s... Class II Zimmer, Inc.
Feb 7, 2013 Technocut Plus, Sterile Single Use Safety Scalpel, Distributed by: Myco Medi... Pouch labeling/printing errors and defective packaging resulting in possible compromised sterility. Class II Myco Medical Supplies Inc
Jan 14, 2013 BREG Cold Therapy Combination Units containing Sterile Polar Pads. 02356 Rev ... The recall was initiated because Breg has determined that some Sterile Polar Pads products manufa... Class II Breg Inc
Jan 14, 2013 BREG Sterile Polar Pads; 02356 Rev M, PAD M/U XL STER, Mfg.Date: 112012. Mode... The recall was initiated because Breg has determined that some Sterile Polar Pads products manufa... Class II Breg Inc
Jan 11, 2013 NEUROPATH 6Fx90 GUIDING CATH ST Product Code: GST60900000 Intended for us... Sterility of device may be compromised due to lack of package integrity Class II Codman & Shurtleff, Inc.
Jan 11, 2013 NEUROPATH 6Fx100 GUIDING CATH MP Product Code: GMD61000000 Intended for u... Sterility of device may be compromised due to lack of package integrity Class II Codman & Shurtleff, Inc.
Jan 11, 2013 NEUROPATH 6Fx100 GUIDING CATH ST Product Code: GST61000000 Intended for u... Sterility of device may be compromised due to lack of package integrity Class II Codman & Shurtleff, Inc.
Jan 11, 2013 NEUROPATH 6Fx100 GUIDING CATH S2 Product Code: GSM61000000 Intended for ... Sterility of device may be compromised due to lack of package integrity Class II Codman & Shurtleff, Inc.
Jan 11, 2013 NEUROPATH 5Fx100 GUIDING CATH HH Product Code: GMC51000000 Intended for u... Sterility of device may be compromised due to lack of package integrity Class II Codman & Shurtleff, Inc.
Jan 11, 2013 NEUROPATH 6Fx100 GUIDING CATH MC Product Code: GCB61000000 Intended for u... Sterility of device may be compromised due to lack of package integrity Class II Codman & Shurtleff, Inc.
Jan 11, 2013 NEUROPATH 6Fx100 GUIDING CATH MPD Product Code: GMD60900000 Intended for ... Sterility of device may be compromised due to lack of package integrity Class II Codman & Shurtleff, Inc.
Jan 11, 2013 NEUROPATH 5Fx90 GUIDING CATH ST Product Code: GST50900000 Intended for us... Sterility of device may be compromised due to lack of package integrity Class II Codman & Shurtleff, Inc.
Jan 11, 2013 NEUROPATH 6Fx90 GUIDING CATH MPC Product Code: GMC60900000 Intended for u... Sterility of device may be compromised due to lack of packaging integrity Class II Codman & Shurtleff, Inc.
Jan 11, 2013 NEUROPATH 5Fx100 GUIDING CATH S2 Product Code: GSM51000000 Intended for u... Sterility of device may be compromised due to lack of package integrity Class II Codman & Shurtleff, Inc.
Jan 11, 2013 NEUROPATH 5Fx90 GUIDING CATH HH Product Code: GHH50900000 Intended for us... Sterility of device may be compromised due to lack of package integrity Class II Codman & Shurtleff, Inc.
Jan 11, 2013 NEUROPATH 6Fx100 GUIDING CATH HH Product Code: GHH61000000 Intended for u... Sterility of device may be compromised due to lack of package integrity Class II Codman & Shurtleff, Inc.
Jan 11, 2013 NEUROPATH 5Fx90 GUIDING CATH S2 Product Code: GSM50900000 Intended for us... Sterility of device may be compromised due to lack of package integrity Class II Codman & Shurtleff, Inc.
Jan 11, 2013 NEUROPATH 5Fx100 GUIDING CATH ST Product Code: GST51000000 Intended for u... Sterility of device may be compromised due to lack of package integrity Class II Codman & Shurtleff, Inc.
Jan 11, 2013 NEUROPATH 5Fx90 GUIDING CATH MPC Product Code: GMC50900000 Intended for u... Sterility of device may be compromised due to lack of package integrity Class II Codman & Shurtleff, Inc.
Jan 11, 2013 NEUROPATH 5Fx90 GUIDING CATH MCV Product Code: GCB50900000 Intended for u... Sterility of device may be compromised due to lack of package integrity Class II Codman & Shurtleff, Inc.
Jan 11, 2013 NEUROPATH 6Fx100 GUIDING CATH MP Product Code: GMC61000000 Intended for u... Sterility of device may be compromised due to lack of package integrity Class II Codman & Shurtleff, 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.