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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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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
Jul 19, 2015 Elcam Medical Minimal Residual Volume Luer activated Swabbable stopcock (MRVL... Punctured blister packages were detected during the packaging process at the manufacturing site. ... Class II Elcam Medical, Inc.
Jul 19, 2015 Elcam Medical MANI 3G Plate BLS RAD B.BRAUN; Manifold for pressure monitoring... Punctured blister packages were detected during the packaging process at the manufacturing site. ... Class II Elcam Medical, Inc.
Jul 10, 2015 Stryker Sustainability Solutions CB5LT Ethicon Endo-Surgery, Inc. Excel T... Stryker Sustainability Solutions has received reports indicating that devices from one lot (lot# ... Class II Stryker Sustainability Solutions
Jul 7, 2015 Magic3 Hydrophilic-coated Female Intermittent Urinary Catheters (6"), 16 Fr, ... Potential breach of the sterile barrier packaging. Class II C.R. Bard, Inc.
Jul 7, 2015 Magic3 Hydrophilic-coated Female Intermittent Urinary Catheters (6"), 10 Fr, ... Potential breach of the sterile barrier packaging. Class II C.R. Bard, Inc.
Jul 7, 2015 Magic3 Hydrophilic-coated Female Intermittent Urinary Catheters (6"), 14 Fr, ... Potential breach of the sterile barrier packaging. Class II C.R. Bard, Inc.
Jul 7, 2015 Magic3 Hydrophilic-coated Female Intermittent Urinary Catheter 14 Fr in the I... Potential breach of the sterile barrier packaging. Class II C.R. Bard, Inc.
Jul 7, 2015 Magic3 Hydrophilic-coated Female Intermittent Urinary Catheters (6"), 12 Fr, ... Potential breach of the sterile barrier packaging. Class II C.R. Bard, Inc.
Jun 24, 2015 Radio-Capitellum, Capitellum, Left, Large, Do Not Reuse, Rx Only. Indicated f... Stryker is recalling rHead, uHead, Sigmoid Notch, Remotion, Radio Capitellum because packaging in... Class II Stryker Howmedica Osteonics Corp.
Jun 24, 2015 Recon, Radial Implant, Standard Stem, Size 1, Sterile, Do Not Reuse, Rx Only.... Stryker is recalling rHead, uHead, Sigmoid Notch, Remotion, Radio Capitellum because packaging in... Class II Stryker Howmedica Osteonics Corp.
Jun 24, 2015 Sigmoid Notch, Radial Plate, Small, Sterile, Do Not Reuse, Rx Only. Intended... Stryker is recalling rHead, uHead, Sigmoid Notch, Remotion, Radio Capitellum because packaging in... Class II Stryker Howmedica Osteonics Corp.
Jun 24, 2015 uHead, Ulnar Implant, Standard Stem, Size 1, Sterile, Rx Only. Intended for r... Stryker is recalling rHead, uHead, Sigmoid Notch, Remotion, Radio Capitellum because packaging in... Class II Stryker Howmedica Osteonics Corp.
Jun 24, 2015 rHead Lateral Stem, Size 1, Do Not Reuse, Sterile. Intended for replacement o... Stryker is recalling rHead, uHead, Sigmoid Notch, Remotion, Radio Capitellum because packaging in... Class II Stryker Howmedica Osteonics Corp.
Jun 4, 2015 A.L.P.S., 3.5mm x 60 mm Cortical Locking Screw. Bone fixation screw Sterile packaging was not sealed. The implantation of an unsterile screw may lead to infection. Class II Biomet, Inc.
Jun 2, 2015 Accurus 2500 Standalone Vitreous Probe REF 8065741018; Accurus 23 GA Standalo... Insufficient seal on the outside packaging, potentially affecting the sterility of the product. Class II Alcon Research, Ltd.
May 8, 2015 0210-312-000-Woundcare Replacement kit with soft tip; 0210-318-000; Woundcare... Potential sterility breach in the packaging. Class II Stryker Instruments Div. of Stryker Corporation
May 1, 2015 Integra¿ Long Epidural Steroid Injection Needle (Tuohy Needle), 20 gauge x 5 ... Integra LifeSciences Corp. d.b.a. Integra Pain Management Announces Voluntary Recall of Tuohy Nee... Class II Integra LifeSciences Corp. d.b.a. Integra Pain ...
Apr 28, 2015 VenaSeal, Sapheon Closure System, Model # SP-101, VS-301 and VS-402. For vasc... Possible sterility breach of the outer packaging (pouch) material which may compromise the outsid... Class II Covidien LLC
Apr 22, 2015 Breast Augmentation Pack, Kit part number AMS1786, AMS1786(A, AMS2790, AMS332... The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were reca... Class II Windstone Medical Packaging, Inc.
Apr 22, 2015 Dr Bragg Vein Tray - RX, kit numbers 007912-5, 007912-6, 007912-7, 007912-8 ... The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were reca... Class II Windstone Medical Packaging, Inc.
Apr 22, 2015 Custom Breast Augmentation Pack, Kit number PSS2455(B, PSS2455(C, PSS2455(D ... The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were reca... Class II Windstone Medical Packaging, Inc.
Apr 22, 2015 HSG Pack, Kit number PSS3287 convenience custom kits used for general surger... The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were reca... Class II Windstone Medical Packaging, Inc.
Apr 22, 2015 Hystero Pack, Kit number PSS3535 convenience custom kits used for general su... The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were reca... Class II Windstone Medical Packaging, Inc.
Apr 22, 2015 Bayview Abdominoplasty Pack, Kit part number 009079-1 convenience custom kit... The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were reca... Class II Windstone Medical Packaging, Inc.
Apr 22, 2015 Custom Venous Kit, TVS4024(C convenience custom kits used for general surg... The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were reca... Class II Windstone Medical Packaging, Inc.
Apr 22, 2015 Vein Kit - No Introducer TVS4027-NI(A convenience custom kits used for gen... The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were reca... Class II Windstone Medical Packaging, Inc.
Apr 22, 2015 Vaginal Pack, Kit number AMS1722 convenience custom kits used for general ... The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were reca... Class II Windstone Medical Packaging, Inc.
Apr 22, 2015 Surgical Pack, Kit number PSS3540 and PSS3540(A convenience custom kits us... The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were reca... Class II Windstone Medical Packaging, Inc.
Apr 22, 2015 Nasal Pack, Kit number PSS2186 convenience custom kits used for general su... The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were reca... Class II Windstone Medical Packaging, Inc.
Apr 22, 2015 Upper Torso Tray, Kit number PSS1554(B convenience custom kits used for ge... The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were reca... Class II Windstone Medical Packaging, Inc.
Apr 22, 2015 Mohs Closer Pack, kit number PSS1827(A, PSS1827(B, and PSS1827(C convenience... The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were reca... Class II Windstone Medical Packaging, Inc.
Apr 22, 2015 Knee Scope Pack, Kit number AMS2498 and AMS2498(A convenience custom kits us... The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were reca... Class II Windstone Medical Packaging, Inc.
Apr 22, 2015 GYN-Laparoscopy Tray AMS1196(A convenience custom kits used for general surg... The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were reca... Class II Windstone Medical Packaging, Inc.
Apr 22, 2015 Anterior Cervical Fusion Pack, Kit part numbers: AMS2502 and AMS2502(A conve... The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were reca... Class II Windstone Medical Packaging, Inc.
Apr 22, 2015 Plastic General Pack, Kit number AMS4215 convenience custom kits used for ... The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were reca... Class II Windstone Medical Packaging, Inc.
Apr 22, 2015 Major Laparotomy Pack - NS, kit number AMS4347 convenience custom kits used ... The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were reca... Class II Windstone Medical Packaging, Inc.
Apr 22, 2015 General Surgery Pack, Kit number PSS1380(A convenience custom kits used for ... The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were reca... Class II Windstone Medical Packaging, Inc.
Apr 22, 2015 Laparoscopic Pack, Kit number AMS2499 convenience custom kits used for gen... The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were reca... Class II Windstone Medical Packaging, Inc.
Apr 22, 2015 Lower Extremity Pack, Kit number AMS1375(A, AMS2540, AMS2540(A, and AMS4669. ... The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were reca... Class II Windstone Medical Packaging, Inc.
Apr 22, 2015 Plastic Kit, Kit number CMP1084(B convenience custom kits used for general... The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were reca... Class II Windstone Medical Packaging, Inc.
Apr 22, 2015 Minor Pack AMS1374(A, CMP1560, PSS3517, PSS3517(A, PSS3518, PSS3518(A, PSS354... The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were reca... Class II Windstone Medical Packaging, Inc.
Apr 22, 2015 Peri GYN, Kit number PSS2193(A convenience custom kits used for general su... The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were reca... Class II Windstone Medical Packaging, Inc.
Apr 22, 2015 General Male Pack, Kit number AMS1580 convenience custom kits used for gener... The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were reca... Class II Windstone Medical Packaging, Inc.
Apr 22, 2015 Morris Hysto Pack, Kit number PSS3198 and PSS3198(A convenience custom kit... The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were reca... Class II Windstone Medical Packaging, Inc.
Apr 22, 2015 D & C Kit, Kit number CMP1466 and CMP1466(A convenience custom kits used for... The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were reca... Class II Windstone Medical Packaging, Inc.
Apr 22, 2015 Endoscopy Pack, Kit number PSS1646 convenience custom kits used for genera... The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were reca... Class II Windstone Medical Packaging, Inc.
Apr 22, 2015 Facial Tray, Kit number PSS1558(A convenience custom kits used for general... The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were reca... Class II Windstone Medical Packaging, Inc.
Apr 22, 2015 Pelviscopy/Laparoscopy Pack, Kit number PSS3342 convenience custom kits us... The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were reca... Class II Windstone Medical Packaging, Inc.
Apr 22, 2015 Basic Extended Pack, kit part number AMS4421. convenience custom kits used... The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were reca... Class II Windstone Medical Packaging, Inc.
Apr 22, 2015 Ortho Kit, Kit number PSS1039(A and PSS1039(B convenience custom kits used... The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were reca... Class II Windstone Medical Packaging, 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.