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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

3,282 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,282 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 3,282 FDA device recalls.

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DateProductReasonClassFirm
Dec 15, 2016 ETEST Tobramycin TM256 FOAM packaging, Product Name: ETEST Tobramycin TM 0.01... Product Stability issues: The current shelf-life claims of the ETEST products are not supported ... Class II BioMerieux SA
Dec 15, 2016 ETEST Benzyl Penicillin PG256 FOAM packaging, Product Name: Etest Benzylpenic... Product Stability issues: The current shelf-life claims of the ETEST products are not supported ... Class II BioMerieux SA
Dec 15, 2016 ETEST Cephalotin CE 256 Foam packaging, Product Name: ETEST Cephalothin CE 0.... Product Stability issues: The current shelf-life claims of the ETEST products are not supported ... Class II BioMerieux SA
Dec 15, 2016 Ciprofloxacin CI 32 Foam packaging, Product Name: ETEST Ciprofloxacin CI 0.00... Product Stability issues: The current shelf-life claims of the ETEST products are not supported ... Class II BioMerieux SA
Dec 15, 2016 ETEST Gentamicin GM256 FOAM packaging, Product Name: ETEST Gentamicin GM 0.01... Product Stability issues: The current shelf-life claims of the ETEST products are not supported ... Class II BioMerieux SA
Dec 15, 2016 ETEST Ceftazidime TZ256 Foam packaging, Product Name: ETEST Ceftazidime TZ 0.... Product Stability issues: The current shelf-life claims of the ETEST products are not supported ... Class II BioMerieux SA
Dec 15, 2016 ETEST Vancomycin VA 256 FOAM packaging, Product Name: ETEST Vancomycin VA 0.0... Product Stability issues: The current shelf-life claims of the ETEST products are not supported ... Class II BioMerieux SA
Dec 15, 2016 ETEST Ceftriaxone TXL32 FOAM packaging, Product Name: ETEST Ceftriaxone TX 0.... Product Stability issues: The current shelf-life claims of the ETEST products are not supported ... Class II BioMerieux SA
Dec 15, 2016 ETEST Doripenem DOR32 FOAM packaging, Product Name: Etest Doripenem DOR 0.00... Product Stability issues: The current shelf-life claims of the ETEST products are not supported ... Class II BioMerieux SA
Dec 14, 2016 10 mm Distraction Pin, Aggressive Qty: 1 per pack; STERILE; Manufactured for:... Product's non-conformity involves the integrity of the seal in the sterile packaging. It is possi... Class II MEDLINE INDUSTRIES INC
Dec 14, 2016 16 mm [or 18 mm] Distraction Pin, Qty: 1 per pack; STERILE; Manufactured for:... Product's non-conformity involves the integrity of the seal in the sterile packaging. It is possi... Class II MEDLINE INDUSTRIES INC
Dec 14, 2016 12 mm Distraction Pin, Blunt Qty: 1 per pack; STERILE; Manufactured for: Medl... Product's non-conformity involves the integrity of the seal in the sterile packaging. It is possi... Class II MEDLINE INDUSTRIES INC
Dec 14, 2016 16 mm Distraction Pin, Titanium, Qty: 1 per pack; STERILE; Manufactured for: ... Product's non-conformity involves the integrity of the seal in the sterile packaging. It is possi... Class II MEDLINE INDUSTRIES INC
Dec 14, 2016 14 mm Distraction Pin, Exagg Qty: 1 per pack; STERILE; Manufactured for: Medl... Product's non-conformity involves the integrity of the seal in the sterile packaging. It is possi... Class II MEDLINE INDUSTRIES INC
Dec 13, 2016 Boston Scientific Imager II Angiographic Catheter, M001316581 (5-pack outer p... One lot of Imager II Angiographic Catheters is being recalled due to packaging mislabeling. The ... Class II Boston Scientific Corporation
Dec 7, 2016 Tibial Component Metal Cased Small Long; Tibial Component Metal Cased Small S... The recalling firm has received 5 customer inquiries reporting that at least one pouch of the dou... Class II Stanmore Implants Worldwide Ltd.
Dec 7, 2016 Femoral Shaft L=120mm; Femoral Shaft L=135mm; Femoral Shaft L=150mm The prod... The recalling firm has received 5 customer inquiries reporting that at least one pouch of the dou... Class II Stanmore Implants Worldwide Ltd.
Dec 7, 2016 DF Coated Integral Shaft & Stem 15x30x38; DF Coated Integral Shaft & Stem ... The recalling firm has received 5 customer inquiries reporting that at least one pouch of the dou... Class II Stanmore Implants Worldwide Ltd.
Dec 7, 2016 Medacta International SA, M.U.S.T. Rod, REF 03.50.433, Size 5.5mm, Length 480... Damaged packaging, lack of sterility assurance Class II Medacta Usa Inc
Dec 7, 2016 Femoral Integral Shaft & Stem 15x27 HA Coated; Femoral Integral Shaft & Ste... The recalling firm has received 5 customer inquiries reporting that at least one pouch of the dou... Class II Stanmore Implants Worldwide Ltd.
Dec 7, 2016 Tibial Component Fixed Hinge Small Long; Tibial Component Fixed Hinge Small S... The recalling firm has received 5 customer inquiries reporting that at least one pouch of the dou... Class II Stanmore Implants Worldwide Ltd.
Dec 6, 2016 Reprocessed Electrophysiology Catheter Cables Catalog Number: CB3434CT, D134... A breach in the sterile packaging may have occurred resulting in potentially non-sterile product. Class II Stryker Sustainability Solutions
Dec 6, 2016 Reprocessed Ablation Catheter Cable Catalog Number: CR3425CT, CR3434CT Ab... A breach in the sterile packaging may have occurred resulting in potentially non-sterile product. Class II Stryker Sustainability Solutions
Nov 29, 2016 Atrium Medical Oasis Blood Recovery Drains as follows: 3650-100 Oasis Blood ... Outer Packaging is not sterile Class II Atrium Medical Corporation
Nov 29, 2016 Atrium Medical 3620-100: Oasis dual chamber drain with in-line connectors (2 ... Outer Packaging is not sterile Class II Atrium Medical Corporation
Nov 29, 2016 Atrium Medical 16400 Express Mini 500 dry seal drain Product Usage: To evac... Outer Packaging is not sterile Class II Atrium Medical Corporation
Nov 29, 2016 Atrium Medical Ocean Blood Recovery Drains as follows: 2050-000 Ocean Blood... Outer Packaging is not sterile Class II Atrium Medical Corporation
Nov 29, 2016 Atrium Medical Ocean Drains as follows: 2002-000 Ocean single drain, with i... Outer Packaging is not sterile Class II Atrium Medical Corporation
Nov 29, 2016 Atrium Medical Pediatric Chamber Ocean Drains as follows: 2012-320 Ocean In... Outer Packaging is not sterile Class II Atrium Medical Corporation
Nov 29, 2016 Atrium Medical Oasis Single Drain as follows: 3600-100 Oasis single drain w... Outer Packaging is not sterile Class II Atrium Medical Corporation
Nov 29, 2016 Atrium Medical Oasis Pediatric Drain as follows: 3612-100 Oasis Infant/Pedi... Outer Packaging is not sterile Class II Atrium Medical Corporation
Nov 29, 2016 Atrium Medical Dual Chamber Ocean Drains as follows: 2020-000 Ocean dual ch... Outer Packaging is not sterile Class II Atrium Medical Corporation
Nov 29, 2016 Atrium Medical 400 Series Express Drains as follows: 4000-100N Express sing... Outer Packaging is not sterile Class II Atrium Medical Corporation
Nov 11, 2016 Reprocessed Xcel Bladeless Trocar (H12LP) Model # H12LP Reprocessed Endosco... An increase in reports indicating that the reprocessed H12LP Trocar adjustable plug may break in ... Class II Stryker Sustainability Solutions
Nov 9, 2016 GAM Kirschner Wire, Sterile R, T2 K-Wire, Sterile R and T2 K-Wire Recon, Stry... A review of packaging revealed the seal integrity of the pouch may be compromised. More specifica... Class II Stryker Howmedica Osteonics Corp.
Nov 9, 2016 Elana Surgical KitHUD The Elana Surgical KitHUD, when connected to the Spect... Elana has issued this Field Action to voluntarily remove specific serial numbers of our Elana Sur... Class II Elana, Inc.
Oct 31, 2016 ELCA Coronary Atherectomy Catheter. Models: 110-001, 110-002, 110-004, 114-00... Spectranetics Corporation announces a voluntary field action for the Turbo Elite Atherectomy Cath... Class II Spectranetics Corporation
Oct 31, 2016 Turbo Elite Atherectomy Catheter. Models: 410-152, 410-154, 414-151, 414-159,... Spectranetics Corporation announces a voluntary field action for the Turbo Elite Atherectomy Cath... Class II Spectranetics Corporation
Oct 31, 2016 Bridge Occlusion Balloon. Model: 590-001 Temporary vessel occlusion of the s... Spectranetics Corporation announces a voluntary field action for the Turbo Elite Atherectomy Cath... Class II Spectranetics Corporation
Oct 20, 2016 Nordson Micromedics FibriJet Endoscopic Catheter Introducer, Catalog Number S... The sterile packaging may contain small channels in the seal of the pouch, If the channels are p... Class II Micromedics, Inc.
Oct 14, 2016 Covidien Precision Specimen Container- 4 oz (118 mL), Plastic Screw Top Cap, ... Sterility of the outer surface of the container compromised due to packaging defect. Class II Covidien LLC
Oct 12, 2016 DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-DRILLING SCR... SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging. Class II DePuy Spine, Inc.
Oct 12, 2016 DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE OVERSIZED SCREW ... SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging. Class II DePuy Spine, Inc.
Oct 12, 2016 DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM CONSTRAINED OVERSIZED SCRE... SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging. Class II DePuy Spine, Inc.
Oct 12, 2016 DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-DRILLING SC... SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging. Class II DePuy Spine, Inc.
Oct 12, 2016 DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-TAPPING SCRE... SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging. Class II DePuy Spine, Inc.
Oct 12, 2016 DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM CONSTRAINED SELF-TAPPING ... SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging. Class II DePuy Spine, Inc.
Oct 12, 2016 Algerbrush-II Product Usage: Medical - For surgeons to use in ophthalmic ... According to firm ( Bausch & Lomb, Inc. ) on June 17, 2016 a packaging operator notified his sup... Class II Bausch & Lomb, Inc.
Oct 12, 2016 DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-TAPPING SCR... SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging. Class II DePuy Spine, Inc.
Sep 29, 2016 FindrWIRZ Guidewire System Catalog# 40-05 Cardiology: The system is inten... A complaint was received on September 27th, 2016 at a medical center in Germany for delamination ... Class I SentreHeart 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.