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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

3,164 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,164 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 3,164 FDA device recalls.

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DateProductReasonClassFirm
Aug 25, 2015 Regard, Item Number 800301001, Sterile, CV0708A - OPEN HEART- Custom surgical... Custom surgical kits contain a component (ORS fluid warming and slush drapes) that was recalled d... Class II Resource Optimization & Innovation Llc
Aug 25, 2015 Regard, Item Number 830019, CV0214H -Custom surgical kit for cardiovascular s... Custom surgical kits contain a component (ORS fluid warming and slush drapes) that was recalled d... Class II Resource Optimization & Innovation Llc
Aug 25, 2015 Regard, Item Number 830054001, CV00625A - OPEN HEART A&B - Custom surgical ki... Custom surgical kits contain a component (ORS fluid warming and slush drapes) that was recalled d... Class II Resource Optimization & Innovation Llc
Aug 19, 2015 Regard Custom Surgical Pack, Item Number: 800628; Sterile, CV0805 - CABG B. U... Surgical kits contain a surgical scrub product which may be chemically contaminated and lack ster... Class II Resource Optimization & Innovation Llc
Aug 19, 2015 Regard Custom Surgical Pack, Item Number: 800208002; Sterile, CV0361B - CABG ... Surgical kits contain a surgical scrub product which may be chemically contaminated and lack ster... Class II Resource Optimization & Innovation Llc
Aug 6, 2015 Mahurkar Acute Dual Lumen Catheter Tray, High Flow Straight Extensions with I... Sterility may be compromised Class II Covidien LLC
Aug 6, 2015 Mahurkar" Elite Acute Dual Lumen Catheter Tray, Straight Extensions with IC* ... Sterility may be compromised Class II Covidien LLC
Aug 6, 2015 Mahurkar Elite Acute Dual Lumen Catheter Tray, Curved Extensions with IC* Saf... Sterility may be compromised Class II Covidien LLC
Aug 6, 2015 Mahurkar Elite Acute Triple Lumen Catheter Tray, Curved Extensions with IC* S... Sterility may be compromised Class II Covidien LLC
Aug 6, 2015 Mahurkar Elite Acute Dual Lumen Catheter Tray, Curved Extensions with IC* Saf... Sterility may be compromised Class II Covidien LLC
Aug 6, 2015 MAHURKAR 12Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20cm, Strai... Sterility may be compromised Class II Covidien LLC
Aug 6, 2015 Mahurkar Elite Acute Dual Lumen Catheter Tray, High Flow Pre-Curved with IC* ... Sterility may be compromised Class II Covidien LLC
Aug 6, 2015 MAHURKAR"* 12Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20cm, Cur... Sterility may be compromised Class II Covidien LLC
Aug 6, 2015 Mahurkar Elite Acute Dual Lumen Catheter Tray, High Flow Straight Extensions ... Sterility may be compromised Class II Covidien LLC
Aug 6, 2015 Mahurkar Elite Acute Triple Lumen Catheter Tray, Curved Extensions with IC* S... Sterility may be compromised Class II Covidien LLC
Aug 6, 2015 Mahurkar Acute Dual Lumen Catheter Tray, High Flow¿ Pre-Curved with IC* Safet... Sterility may be compromised Class II Covidien LLC
Aug 6, 2015 MAHURKAR 12Fr High Pressure Triple Lumen Acute Dialysis Catheter, 16cm, Curve... Sterility may be compromised Class II Covidien LLC
Aug 6, 2015 Monoject 0.9% Saline Flush Prefill Double Pouch Item Code: 8881570129 Produ... Sterility may be compromised Class II Covidien LLC
Jul 14, 2015 Histolock Resection Device, US Endoscopy. An electrosurgical device desig... The company has determined the sterility cannot be assured for the affected lot. Class II US Endoscopy Group Inc
Jun 18, 2015 Bone Marrow Aspiration Needle 15G x 2.688 MAX, Part Number DBMNI1501; Bone Ma... Potential defect in the forming of the primary package of the blister that may compromise the ste... Class II Argon Medical Devices, Inc
Jun 18, 2015 T-Lok Bone Marrow Biopsy Needle 8G x 4 Ext Can, Part Number DBMNJ0804TL; T-Lo... Potential defect in the forming of the primary package of the blister that may compromise the ste... Class II Argon Medical Devices, Inc
Jun 16, 2015 SYMMETRY SURGICAL DISPOSABLE TOWEL CLAMP, REF 19-4137, STERILE EO, Rx only. ... Lack of sterility assurance. Class II Symmetry Surgical, 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 18, 2015 ActCel advanced bleeding control Topical Hemostatic Dressing 2in X 2in (5... Coreva Health Science, LLC. is recalling ActCel Hemostatic Dressing due to customer literature an... Class II Coreva Health Science LLC
May 12, 2015 T.A.L.O.N (Tactically Advanced Lifesaving Intraosseous Needle) 15G x 38.5 mm ... Potential breach in sterility Class II Vidacare Corporation
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 8, 2015 Gyrus ACMI Diego Elite Tubeset; intended for cutting, coagulation, drilling, ... Potential lack of sterility assurance. Class II Gyrus Acmi, Incorporated
May 8, 2015 Gyrus ACMI Diego Elite Tubeset, intended for cutting, coagulation, drilling, ... Potential lack of sterility assurance. Class II Gyrus Acmi, Incorporated
May 1, 2015 BVI Custom Eyes¿ Ophthalmic Procedure Kits with the component -Devon Light Gl... Devon Light Glove in procedure kits may have holes/slits compromising sterility of the product Class II Beaver-Visitec International Inc.
May 1, 2015 BVI Custom Eyes¿ Ophthalmic Procedure Kits with the component -Devon Light Gl... Devon Light Glove in procedure kits may have holes/slits compromising sterility of the product Class II Beaver-Visitec International Inc.
May 1, 2015 BVI Custom Eyes¿ Ophthalmic Procedure Kits with the component -Devon Light Gl... Devon Light Glove in procedure kits may have holes/slits compromising sterility of the product Class II Beaver-Visitec International Inc.
May 1, 2015 BVI Custom Eyes¿ Ophthalmic Procedure Kits with the component -Devon Light Gl... Devon Light Glove in procedure kits may have holes/slits compromising sterility of the product Class II Beaver-Visitec International Inc.
May 1, 2015 BVI Custom Eyes¿ Ophthalmic Procedure Kits with the component -Devon Light Gl... Devon Light Glove in procedure kits may have holes/slits compromising sterility of the product Class II Beaver-Visitec International Inc.
Apr 30, 2015 ULTRA-FAST FIX Knot Pusher Suture Cutters Product Number: 72201537 Intend... Sterility of device maybe compromised Class II Smith & Nephew, Inc.
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.

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.