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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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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

5,543 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 5,543 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 5,543 FDA device recalls.

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DateProductReasonClassFirm
Sep 13, 2013 Tri-Nex Healing Abutment, 0.50 mm x 5 mm height, Catalog No. HA-L-50-5. T... Southern Implants is recalling the Tri-Nex healing abutment because the package was incorrectly l... Class II Southern Implants, Inc
Sep 10, 2013 VERIFY¿ Dual Species Self-Contained Biological Indicator, Distributed by STER... STERIS has identified that the population of the G. stearothermophilus spores that monitor STEAM ... Class II Steris Corporation
Sep 10, 2013 Ready to Use Thymo-Cide, Germicidal Detergent, containing 0.051% thymol, pack... Expired active ingredient was used in the manufacture of the product. Class II Wexford Labs Inc
Sep 10, 2013 Brand Names: Integra¿ Camino 110-4 Intracranial Pressure (ICP) Monitoring Ca... Integra LifeSciences has identified through an internal evaluation that in order to comply with U... Class II Integra Limited
Sep 9, 2013 *** 1) Product labeled in part: List No. 14220-28; PLUM Y-TYPE BLOOD SET; 200... Intravenous fluid may leak at the CLAVE secondary port of Hospira PlumSet IV administration sets. Class II Hospira Inc.
Sep 9, 2013 *** 1) Product labeled in part: 14951-48; LIFESHIELD; PLUMSET WITH CONVERTIBL... Intravenous fluid may leak at the CLAVE secondary port of Hospira PlumSet IV administration sets. Class II Hospira Inc.
Sep 9, 2013 *** 1) Product labeled in part: List No. 14212-28; LIFESHIELD; PLUM Y-TYPE BL... Intravenous fluid may leak at the CLAVE secondary port of Hospira PlumSet IV administration sets. Class II Hospira Inc.
Sep 9, 2013 *** 1) Product labeled in part: 19683-28; LIFESHIELD; MICRODRIP SOLUSET WITH ... Intravenous fluid may leak at the CLAVE secondary port of Hospira PlumSet IV administration sets. Class II Hospira Inc.
Sep 9, 2013 *** 1) Product labeled in part: 19734-28; LIFESHIELD; LIFESHIELD LATEX-FREE P... Intravenous fluid may leak at the CLAVE secondary port of Hospira PlumSet IV administration sets. Class II Hospira Inc.
Sep 9, 2013 BBL (tm) MGIT (tm) Mycobacteria Growth Indicator Tube, part # 245122, package... An in-vitro diagnostic reagent may be labeled with an incorrect barcode, which when scanned on as... Class II Becton Dickinson & Co.
Sep 4, 2013 Calcium Arsenazo, CALA-0250, For the Quantitative Determination of Total Calc... Calcium Arsenazo Reagent, reference CALA-0250, is recalled due to complaint of plasma specimens r... Class II SEPPIM SAS
Sep 3, 2013 Blanketrol III, Model Number 233, Cincinnati Sub-Zero Products, Inc., 12011 M... During a label review it was discovered that both the Blanketrol III Operations (57201-N) & Opera... Class II Cincinnati Sub-Zero Products Inc
Aug 30, 2013 CareFusion Gravity Set, Model #44000-07 The CareFusion Gravity Sets are us... CareFusion is recalling the Gravity Set (Model 44000-07) because of an incorrect expiration date.... Class II CareFusion 303, Inc.
Aug 28, 2013 *** 1) SYMBIQ One-Channel Infuser; *** 2) SYMBIQ Two-Channel Infuser; **... Hospira shipped the incorrect replaceable battery pack (Part No: HSP3566-E10) instead of the corr... Class II Hospira Inc.
Aug 27, 2013 H&H Emergency Cricothyrotomy Kit (Part No. HHECT01/ HHECTK01, NSN 6515-01-573... Medical device tubing used for endotracheal airway application may become weakened and rendered i... Class I H & H Associates
Aug 26, 2013 Edwards Lifesciences Fem-Flex Femoral Arterial Cannula with Duraflo Coating, ... Edwards Lifesciences is recalling two lots of Duraflo Cannulas due to reported complaints involvi... Class II Edwards Lifesciences, LLC
Aug 26, 2013 Dental Abutment labeled in part: "4555 Riverside Drive Palm Beach Gardens, FL... Reports relating to Biomet 3i's BellaTek Zirconia Dental Abutment fractures were received. Class II Biomet 3i, LLC
Aug 21, 2013 SHOPKO Waterproof Adhesive Pads Antibacterial. Used for covering minor cut... No antibacterial bandages were packed in boxes labeled as antibacterial. Class II ASO, LLC
Aug 19, 2013 TEGRIS system Four labels of the Tegris System include: Emergency butt... MAQUET has identified a potential issue that might occur because of the lack of an emergency stop... Class II Maquet Cardiovascular Us Sales, Llc
Aug 16, 2013 Monoject 10 Units/mL Heparin Lock Flush, 12 mL Syringe with 10 mL Fill Produ... Monoject prefill flush syringes may contain non-sterile water and labeled as saline or heparin Class II Covidien LLC
Aug 16, 2013 Monoject 0.9% Sodium Chloride Flush Syringe, 12 mL Syringe with 5 mL Fill Pr... Monoject prefill flush syringes may contain non-sterile water and labeled as saline or heparin Class II Covidien LLC
Aug 16, 2013 Monoject 0.9% Sodium Chloride Flush Syringe, 12 mL Syringe with 3 mL Fill Pr... Monoject prefill flush syringes may contain non-sterile water and labeled as saline or heparin Class II Covidien LLC
Aug 16, 2013 Monoject 100 Units/mL Heparin Lock Flush, 12 mL Syringe with 10 mL Fill Prod... Monoject prefill flush syringes may contain non-sterile water and labeled as saline or heparin Class II Covidien LLC
Aug 16, 2013 Monoject 10 Units/mL Heparin Lock Flush, 12 mL Syringe with 5 mL Fill Produc... Monoject prefill flush syringes may contain non-sterile water and labeled as saline or heparin Class II Covidien LLC
Aug 16, 2013 POWERWAND Safety Introducer with Extended Dwell Catheter; Catalog no. 92006.... Access Scientific is recalling the POWERWAND Saftey Introducer with Extended Dwell Catheter becau... Class II Access Scientific Inc
Aug 16, 2013 Monoject 100 Units/mL Heparin Lock Flush, 12 mL Syringe with 3 mL Fill Produ... Monoject prefill flush syringes may contain non-sterile water and labeled as saline or heparin Class II Covidien LLC
Aug 16, 2013 Monoject 100 Units/mL Heparin Lock Flush, 12 mL Syringe with 5 mL Fill Produ... Monoject prefill flush syringes may contain non-sterile water and labeled as saline or heparin Class II Covidien LLC
Aug 16, 2013 Monoject 0.9% Sodium Chloride Flush Syringe, 12 mL Syringe with 10 mL Fill P... Monoject prefill flush syringes may contain non-sterile water and labeled as saline or heparin Class II Covidien LLC
Aug 16, 2013 Monoject 10 Units/mL Heparin Lock Flush, 12 mL Syringe with 3 mL Fill Produc... Monoject prefill flush syringes may contain non-sterile water and labeled as saline or heparin Class II Covidien LLC
Aug 12, 2013 Kirschner-Wire (K-Wire), packed in a clear tube with end caps, tubes packed i... A medical device used in surgical procedures was packaged in a pouch in which a defective seal ma... Class II MicroAire Surgical Instruments, LLC
Aug 12, 2013 Cordis ADROIT 6F Guiding Catheter Product Usage: For intravascular introd... Due to a labeling error related to the conversion of the inner diameter of the catheter from inch... Class II Cordis Corporation
Aug 12, 2013 DeRoyal (R) Surgical Eye Spears, REF 30-049, Sterile EO, Manufacturer: DeRoy... One lot of eye spears was labeled as being x-ray detectable, but contained non x-ray detectable p... Class II DeRoyal Industries Inc
Aug 12, 2013 Steinmann Pin, packed in a clear tube with end caps, tubes packed in a steril... A medical device used in surgical procedures was packaged in a pouch in which a defective seal ma... Class II MicroAire Surgical Instruments, LLC
Aug 12, 2013 ADVIA 2120/2120i Hematology Systems with ADVIA Autoslide connected to it, SMN... Siemens determined that if an autosampler rack jam error occurs during operation of an ADVIA 2120... Class II Siemens Healthcare Diagnostics
Aug 9, 2013 Model BP7507 OPTI LION E-Plus Cassettes 25 Cassettes with Sample Probes, OPTI... OPTI LION E-Plus Cassettes were labeled with an incorrect barcode. The incorrect barcode could pe... Class II OPTI Medical Systems, Inc
Aug 8, 2013 Horizon 24 Large Titanium Clips with Adhesive Backing, Ref 004204, Rx Only, S... The manufacturing and expiration dates are not printed on the blister pack label. Class II Teleflex Medical
Aug 7, 2013 Enhancement Medical expression. model # EXP-150. Injectable Gel 1.5cc Syrin... Manufacturer made a change in the production process that resulted in a change in final gel weigh... Class I Enhancement Medical, LLC
Aug 2, 2013 Getinge Assure Accufast Biological Indicators, Catalog Number 61301606636 (50... AccuFast Biological Indicator Lot SR-430 may have been exposed to conditions affecting its viabil... Class II Getinge USA Inc
Jul 31, 2013 2.4 and 2.7 MM Locking Screw SLF-TPNG with T8 Stardrive Recess 12 MM Fixatio... Specific lots of the SS 2.4mm and SS 2.7mm Locking Screw (self-tapping) due to a mislabeling issu... Class II Synthes USA HQ, Inc.
Jul 31, 2013 Arrow International, Inc. Two-Lumen CVC Kit with Blue Flex Tip Catheter. The ... Arrow is recalling the product due to a labeling inconsistency. One portion of the lidstock state... Class II Arrow International Inc
Jul 30, 2013 ZIMMER PERIARTICULAR LOCKING PLATE SYSTEM DISTAL MEDIAL HUMERAL LOCKING PLAT... Zimmer is initiating a lot specific voluntary recall of the Distal Medial Humeral Locking Plate, ... Class II Zimmer, Inc.
Jul 30, 2013 Synthes 2.4 mm LC-DCP Plate 6 Holes/51mm Product Usage: Intended for frac... A complaint was reported regarding a screw being found in a package labeled for 2.4 mm LC-DCP Plate. Class II Synthes (USA) Products LLC
Jul 30, 2013 Synthes Trochanteric Fixation Nail As part of the Synthes Trochanteric Fi... Certain lots of Trochanteric Fixation Nail were distributed to the field with the incorrect label... Class II Synthes USA HQ, Inc.
Jul 30, 2013 Synergetics 25 gauge Soft Tip Cannula, packaged in 6 units per box. Catalog n... One lot of 25 gauge Soft-Tip Disposable Cannulas are co-mingled with 23 gauge cannulas; the produ... Class II Synergetics Inc
Jul 29, 2013 SARKEN STAT! 1- Panel Test Kit-OPI Product Usage: Labeled as FOR FORENSI... These products are being recalled because they were distributed without adequate labeling and ins... Class II Sarken, Inc.
Jul 29, 2013 SARKEN STAT! 1- Panel Test Kit-COC Product Usage- Labeled as FOR FORENSIC... These products are being recalled because they were distributed without adequate labeling and ins... Class II Sarken, Inc.
Jul 29, 2013 SARKEN STAT! Multi-Drug Test Panel Product Usage- Labeled as FOR FORENSIC... These products are being recalled because they were distributed without adequate labeling and ins... Class II Sarken, Inc.
Jul 29, 2013 SARKEN STAT! 1- Panel Test Kit-mAMP Product Usage: Labeled as FOR FORENS... These products are being recalled because they were distributed without adequate labeling and ins... Class II Sarken, Inc.
Jul 29, 2013 SARKEN STAT! 1- Panel Test Kit-THC Product Usage- Labeled as FOR FORENSIC... These products are being recalled because they were distributed without adequate labeling and ins... Class II Sarken, Inc.
Jul 29, 2013 SARKEN STAT! Multi-Drug Test Panel Product Usage- Labeled as FOR FORENSIC... These products are being recalled because they were distributed without adequate labeling and ins... Class II Sarken, 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.