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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

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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
Oct 21, 2015 LeMaitre Over-the-Wire Embolectomy Catheter 4F, 80cm, Model 1651-48 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 4F, 80 cm, Model 1601-48 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 NovaSil Silicone Single Lumen Embolectomy Catheter 6F, 80 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 Over-the-Wire Embolectomy Catheter 3F, 80cm, Model 1651-38. Indicat... 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, 40 cm, Model e-1651-64. Indi... Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead... Class II LeMaitre Vascular, Inc.
Oct 14, 2015 SSS Reprocessed Zimmer, Synthes, Stryker and Linvatec Drill Bits and Blades ... It was reported that packaging was not properly sealed. Class II Stryker Sustainability Solutions
Sep 29, 2015 MaxAn 4.0mm and 4.5mm fixed screws, used in the MaxAn Anterior Cervical Plate... The packaging of 4.5 mm diameter MaxAn screws identifies/labels the screws as 4.0 mm diameter scr... Class II Biomet Spine, LLC
Sep 28, 2015 Exactech Acapella One Interbody Fusion Device Parallel. Orthopedic Spinal Su... Incorrect external and internal packaging labels. Exactech has identified nineteen (19) Acapella ... Class II Exactech, Inc.
Sep 23, 2015 HARMONIC ACE+ 7 Laparoscopic Shears with Advanced Hemostasis (23cm, 36cm, 45c... Complaints of holes in Tyvek which can compromise the sterile barrier provided by the packaging. Class II Ethicon Endo-Surgery Inc
Sep 21, 2015 Stryker Orthopaedics Duracon Flat Tibial Wedge Cemented use only Sterile. Tib... Stryker Orthopaedics has received two customer complaints regarding Duracon Tibial Wedge implants... Class II Stryker Howmedica Osteonics Corp.
Sep 14, 2015 MILEX PESSARY KIT; Model Numbers: MXPES00; MXKPES00; MXKPREG03; MXKPGSK07 ... The products have been identified to have incorrect size prints on the MILEX PESSARY KIT packagin... Class III CooperSurgical, Inc.
Sep 10, 2015 Smith & Nephew MOSAICPLASTY DP- Disposable Harvesting System 8.5 mm, Sterile ... Sterility of device is compromised due to breach in the packaging Class II Smith & Nephew, Inc., Endoscopy Div.
Sep 10, 2015 DeRoyal sterile custom surgical kits: 1) Emergency CABG Pack Pgybk, ref 89-7... These custom sterile surgical kits contain the component, ECOLAB ORS Fluid Warming and Slush Drap... Class II DeRoyal Industries Inc
Sep 10, 2015 Smith & Nephew MOSAICPLASTY DP- Disposable Harvesting System 6.5 mm, Sterile ... Sterility of device is compromised due to breach in the packaging Class II Smith & Nephew, Inc., Endoscopy Div.
Sep 10, 2015 Smith & Nephew MOSAICPLASTY DP- Disposable Harvesting System 4.5 mm, Sterile ... Sterility of device is compromised due to breach in the packaging Class II Smith & Nephew, Inc., Endoscopy Div.
Sep 10, 2015 Smith & Nephew MOSAICPLASTY DP- Disposable Harvesting System 3.5 mm, Sterile ... Sterility of device is compromised due to breach in the packaging Class II Smith & Nephew, Inc., Endoscopy Div.
Sep 9, 2015 Fluorescence Imaging Procedure Kits used with the da Vinci Si and Xi Surgical... B. Braun 2 gang 4-way stopcocks in the Fluorescence Imaging Procedure Kit may experience damage ... Class II Intuitive Surgical, Inc.
Sep 3, 2015 Zimmer Natural Nail CM Long. Intramedullary Fixation Rod. The Zimmer Na... In about 5% of tested samples, the outer tray was found to be compromised. Risks: A damaged oute... Class II Zimmer Gmbh
Aug 31, 2015 MATResponder Tourniquet; Catalog number MATR: UPC 78353 00008; MATCombat Tou... Once tested, it is required that the tourniquet be returned to its Ready position then placed in ... Class II Pyng Medical Corporation
Aug 24, 2015 Zimmer, Reprocessed Zimmer Tourniquet Cuffs,34" Single Hose Single Bladder Br... Sterilmed, Inc. is recalling its reprocessed Zimmer Tourniquet Cuff, Part #ZIM60-7075-106, lot nu... Class II STERILMED, INC.
Aug 24, 2015 Magic3 Intermittent Catheter with Sure Grip Hydrophilic Coated Silicone Coude... Potential breach of the sterile barrier packaging. Class II C.R. Bard, Inc.
Aug 20, 2015 Aliquot Delivery Kit (Syringe and Plunger); for use in open and percutaneous ... Two isolated instances of holes in the outer header bag component of the double barrier sterile p... Class II Orthovita, Inc., dBA Stryker Orthobiologics.
Aug 18, 2015 Microtek Medical, Inc. ORS Fluid Warming and Slush Drapes, Model #'s ORS-10... The sterile packaging may contain small (less than 250 microns wide) channels in the seal of the ... Class II Ecolab Inc
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.

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.