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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

Infrastructure

Bridge Safety624,000 bridge inspections Aviation Safety30,000+ NTSB aviation events Dam Safety92,600 dam safety records Water Safety433,000+ public water systems Railroad Safety438,000+ rail crossings Pipeline Safety8,800+ pipeline incidents State DashboardsSafety grades for all 50 states ZIP ReportAny 5-digit ZIP across 9 datasets

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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
Mar 31, 2016 American Surgical Telfa 3/4" x 3" Ref Number: 80-11 Product Usage: Neuro... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Delicot 6 mm x 50 mm Ref Number: 63-06 Product Usage: Ne... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Telfa 3/8" x 3" Ref Number: 80-05 Product Usage: Neuro... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Delicot non-xray 5 mm x 13 mm Ref Number: 63-02 non-xray ... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Americot Blue 1" x 3" Ref Number: 20-10S Product Usage: ... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Americot Blue 1/4" x 1.5" Ref Number: 20-30S Product Us... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Delicot non-xray 10 mm x 13 mm Ref Number: 63-03 non-xray ... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Delicot 10 mm x 13 mm Ref Number: 63-03 Product Usage: N... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Delicot X 9 mm x 50 mm Ref Number: 63x07 Product Usage: ... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Ultracot 10 mm x 13 mm (Glassine) Ref Number: 23-03G Prod... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Ultracot 5 mm x 13 mm (Glassine) Ref Number: 23-02G Produ... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Uniqcot 1/2" x 1/2" Ref Number: 67-06 Product Usage: Neu... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Americot Blue 3/8" x 2" Ref Number: 20-26S Product Usage:... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Americot Blue 1/2" x 1/2" Ref Number: 20-04S Product Usag... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Ultracot 70 mm x 10090 mm Ref Number: 23-24 Product Usag... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Ray-Cot 1/2" x 3" Ref Number: 60-09 Product Usage: Neuro... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Ultracot 15 mm x 15 mm (Glassine) Ref Number: 23-12G Prod... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Policot 1/2" x 1/2" Ref Number: 90-06 Product Usage: N... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Cotton Balls-Strung 1/2" Ref Number: 30-02 Product Usage:... Product packaging defective compromising sterility Class II American Surgical Company
Mar 30, 2016 AMD-RITMED brand Conforming Stretch Gauze Bandages, Sterile, 6 in x 4/1 yds./... The product lot did not meet sterility requirements based on FDA sampling and analysis. Class II Amd-Ritmed, Inc.
Mar 22, 2016 Spetzler Claw Tip, Universal - 5450-800-311 Spetzler Open Angle Micro Claw ... The Spetzler Claw Tip was packaged with the incorrect Tip Sleeve Assembly. The Tip Sleeve Assembl... Class II Stryker Instruments Div. of Stryker Corporation
Mar 21, 2016 Laparotomy Pack, Part numbers 006268-8 and 007725-8. This is a custom conven... These packs contain item #4037 Kerlix X-ray Detectable Laparotomy Sponges which were recalled by ... Class II Windstone Medical Packaging, Inc.
Mar 21, 2016 General Surgery Pack, part number 006880-3. This is a custom convenience sur... These packs contain item #4037 Kerlix X-ray Detectable Laparotomy Sponges which were recalled by ... Class II Windstone Medical Packaging, Inc.
Mar 21, 2016 Laparotomy Pack Latex Free, part number 007725-7. This is a custom convenien... These packs contain item #4037 Kerlix X-ray Detectable Laparotomy Sponges which were recalled by ... Class II Windstone Medical Packaging, Inc.
Mar 15, 2016 Boston Scientific TSX Transseptal Needle, Model Number M004TSX60o; Used to c... Merit Medical Systems, Inc. is voluntarily conducting a recall of one lot of the TSX" Transseptal... Class II Merit Medical Systems, Inc.
Mar 10, 2016 Poly-bags containing the strap labeled with "Adult" sticker. Each strap ki... On March 9, 2016, the firm was contacted regarding the possibility of incorrect labeling on the o... Class II Ferno-Washington Inc
Mar 10, 2016 Poly-bags containing splint strap labeled with "Pediatric" sticker. Each s... On March 9, 2016, the firm was contacted regarding the possibility of incorrect labeling on the o... Class II Ferno-Washington Inc
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.

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.