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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

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
Feb 28, 2017 Sterile Handpiece Sheaths, P/N 7-796-19, included in the Accessory Packages c... For over a year, the Accessory Packages in the Hyfrecator 2000 ESU cartons were packaged in error... Class II ConMed Corporation
Feb 28, 2017 HYFRECATOR 2000 HANDPIECE SHEATH, REF/Part Number 7-796-19, Rx ONLY, STERILE,... For over a year, the Accessory Packages in the Hyfrecator 2000 ESU cartons were packaged in error... Class II ConMed Corporation
Feb 23, 2017 9.6F Plastic Dignity Mid-Sized CT Port w/Pre-Attached Silicone Catheter The ... The 9.6F port kits were packaged with the incorrect valved peelable introducer. The label states ... Class II Medical Components, Inc dba MedComp
Feb 23, 2017 Ziehm Imaging solo FD Mobile Fluoroscopic C-arm During Ziehm Imaging GmbH FDA inspection, the label for the Collimator and X-ray Control panel wa... Class II Ziehm Imaging Inc
Feb 22, 2017 The Medtronic StrataMR adjustable valves and shunts are designed to provide c... Incorrect valve rotor orientation due to misalignment and/or off-center positioning of the Strata... Class I Medtronic Neurosurgery
Feb 21, 2017 MicroAire K-Wires Mislabeling on three lots of K-Wires. The incorrect product description " dual trocar" instead of... Class II MicroAire Surgical Instruments, LLC
Feb 20, 2017 Terumo Advanced Perfusion System 1-Level Sensor II Pads, Product Usage: ... Terumo CVS initiated a voluntary recall for the Level Sensor II Pads and Level Sensor Gel Pads du... Class II Terumo Cardiovascular Systems Corporation
Feb 20, 2017 Terumo Advanced Perfusion System 1-Level Sensor II Gel Pads Product Usage:... Terumo CVS initiated a voluntary recall for the Level Sensor II Pads and Level Sensor Gel Pads du... Class II Terumo Cardiovascular Systems Corporation
Feb 16, 2017 MotoCLIP(TM) Super Elastic Fusion System, Size 18mm x 14mm x 14mm, REF 1442-1... Seven 18mm x 18mm x 18 mm implants had been placed in kits, packed and labeled as 18mm x 14mm x 1... Class II Crossroads Extremity Systems Llc
Feb 13, 2017 Beckman Coulter Chemistry Analyzer AU680/AU5800, Catalog No. MU907400 (Rack I... Beckman Coulter is recalling the Rack ID Labels because the Rack ID number displayed and the Rack... Class II Beckman Coulter Inc.
Feb 9, 2017 Bivona¿ TTS (Tight to Shaft) Pediatric Tracheostomy Tube, Model No. 67SP035, ... Smiths Medical became aware that one lot of the Bivona¿ 3.5mm TTS Cuffed Pediatric tracheostomy ... Class II Smiths Medical ASD Inc.
Feb 8, 2017 AIA-PACK TgAb CONTROL SET The label contains two different methodologies. Quality Control values for non-FDA approved metho... Class III Tosoh Bioscience, Inc.
Feb 8, 2017 AIA-PACK TPOAb CONTROL SET The label contains two different methodologies. Quality Control values for non-FDA approved metho... Class III Tosoh Bioscience, Inc.
Feb 7, 2017 LeMaitre Vascular Reddick Cholangiogram Stiffer Catheter (eIFU) REF# e2400-51 The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch Class II LeMaitre Vascular, Inc.
Feb 7, 2017 LeMaitre Vascular Reddick Cholangiogram Stiffer Catheter with introducer (pap... The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch Class II LeMaitre Vascular, Inc.
Feb 7, 2017 LeMaitre Vascular Reddick Cholangiogram Catheter (eIFU) REF# e2400-50 The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch Class II LeMaitre Vascular, Inc.
Feb 7, 2017 LeMaitre Vascular Scoop Tip Cholangiogram Catheter with Introducer (eIFU) RE... The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch Class II LeMaitre Vascular, Inc.
Feb 7, 2017 LeMaitre Vascular Reddick Scoop Tip Cholangiogram Stiffer Catheter (paper IFU... The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch Class II LeMaitre Vascular, Inc.
Feb 7, 2017 LeMaitre Vascular Reddick Scoop Tip Cholangiogram Catheter with Introducer (e... The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch Class II LeMaitre Vascular, Inc.
Feb 7, 2017 LeMaitre Vascular Scoop Tip Cholangiogram Catheter with Introducer (eIFU) RE... The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch Class II LeMaitre Vascular, Inc.
Feb 7, 2017 LeMaitre Vascular Reddick Scoop Tip Cholangiogram Catheter (eIFU) REF# e240... The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch Class II LeMaitre Vascular, Inc.
Feb 7, 2017 LeMaitre Vascular Reddick Cholangiogram Stiffer Catheter with introducer (eIF... The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch Class II LeMaitre Vascular, Inc.
Feb 7, 2017 LeMaitre Vascular Reddick Cholangiogram Catheter with introducer(eIFU) REF #... The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch Class II LeMaitre Vascular, Inc.
Feb 7, 2017 LeMaitre Vascular Scoop Tip Cholangiogram Catheter with Introducer (paper IFU... The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch Class II LeMaitre Vascular, Inc.
Feb 7, 2017 LeMaitre Vascular Reddick Scoop Tip Cholangiogram Stiffer Catheter with Intr... The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch Class II LeMaitre Vascular, Inc.
Feb 2, 2017 Smith & Nephew Dyonics Saw Blade, Standard, Thick, Product Number 3702 The single use devices are provided sterile and do not have an expiration date on the label. Class II Smith & Nephew, Inc.
Feb 2, 2017 Smith & Nephew Dyonics Saw Blade, Long, Special, Product Number 3706 The single use devices are provided sterile and do not have an expiration date on the label. Class II Smith & Nephew, Inc.
Feb 2, 2017 Smith & Nephew Dyonics Saw Blade, Short, Product Number 3703 The single use devices are provided sterile and do not have an expiration date on the label. Class II Smith & Nephew, Inc.
Feb 2, 2017 Smith & Nephew Dyonics Saw Blade, Short, Narrow, Product Number 3704 The single use devices are provided sterile and do not have an expiration date on the label. Class II Smith & Nephew, Inc.
Feb 2, 2017 Smith & Nephew Dyonics Saw Blade, Narrow, Product Number 3705 The single use devices are provided sterile and do not have an expiration date on the label. Class II Smith & Nephew, Inc.
Feb 2, 2017 Smith & Nephew Dyonics Saw Blade, Standard, Product Number 3701 The single use devices are provided sterile and do not have an expiration date on the label. Class II Smith & Nephew, Inc.
Jan 31, 2017 PRODISC Orthopedic Manual Surgical Instrument, strut used in spinal surgery. ... These items are incorrectly etched and labeled. The item etched and labeled as 10mm Strut 03.820... Class II Synthes (USA) Products LLC
Jan 30, 2017 LipiFlow Thermal Pulsation System/LipiFlow, System Activator (Disposable), Rx... Labeling: The labeled storage temperature is not consistent with the temperature conditions teste... Class II Tearscience, Inc
Jan 27, 2017 BD Vacutainer Sodium Polyanetholesulfonate 5.95 mg Sodium Chloride 14.4 mg Bl... After a receiving a customer complaint for incorrect labeling, BD has confirmed that a portion of... Class II Becton Dickinson & Company
Jan 25, 2017 The UNI-CP System; Model Number: 330230SND. The firm received one complaint from one non-US sales representative (France) that the label on t... Class III Integra LifeSciences Corp.
Jan 25, 2017 OP7543 Design Y Mandible Onlay - Medium - Left and OP7544 Design Y Mandible O... Mislabeling. The packaging labeled as left mandible contained a right mandible. Class II Matrix Surgical Holdings, LLC
Jan 20, 2017 Atrium PVC 10 Fr Straight Thoracic Catheter Code Number: 8010 Labeling icon depicts a catheter having six (6) eyelets; however the correct number of eyelets o... Class II Atrium Medical Corporation
Jan 20, 2017 Atrium PVC 8 Fr Straight Thoracic Catheter Code Number: 8008 Labeling icon depicts a catheter having six (6) eyelets; however the correct number of eyelets o... Class II Atrium Medical Corporation
Jan 14, 2017 MEDHOT MTI 2000 THERMAL IMAGING SYSTEM - TotalVision software with Elevated B... Indications for use are not cleared or approved for market in the U.S. Class II Med-Hot Thermal Imaging, Inc.
Jan 13, 2017 Teleflex Green Non-Latex Robertazzi Nasopharyngeal Airway, Catalog No. 123130... Labeling error Class II Teleflex Medical
Jan 10, 2017 Rusch Greenlite MAC 1, Catalog Number 004551001. Used during tracheal intuba... The pouch may contain the incorrect Rusch Green Lite product size. Pouches that are labeled as c... Class II Teleflex Medical
Jan 8, 2017 Laerdal Compact Suction Unit ¿ 4 under the following labels: 1) 300 ml (3.3 l... The On/Off functionality in the LCSU 4 is controlled by electronic components, one of which might... Class II Laerdal Medical Corporation
Jan 6, 2017 Color contact lenses labeled under the following brands: Diamond, Fierce, Amb... Sterility and Misbranding: Lenses may not be sterile and may be labeled with erroneous lot number... Class II The See Clear Company
Jan 4, 2017 Vanguard Total Knee System Vanguard Open Box Femoral Components Item Numb... packaging of some femoral components was incorrectly labeled as either smaller or larger and/or a... Class II Zimmer Biomet, Inc.
Jan 3, 2017 QUINTUBE Monitor Pack (5 tubes/pk, 24 pk/case) (Non-Sterile) SPG Bulb Drain ... An incorrect sterility status on the label, non-sterile products labeled as sterile Class II Stryker Leibinger GmbH & Co. KG
Jan 3, 2017 9805 Orbital Volume Sizer Set with Tray (Non-sterile) 9951 Design M Malar ... An incorrect sterility status on the label, non-sterile products labeled as sterile Class II Stryker Leibinger GmbH & Co. KG
Dec 28, 2016 Powdered Surgical Gloves, labeled as: a. Baxter and Ansell brand Powdered ... Powdered Surgical Gloves are an FDA banned substance. Class II American Contract Systems, Inc.
Dec 21, 2016 AutoMate 2500 Family Catalog No. ODL25120 AutoMate 1200, ODL25125, AutoMate 1... Beckman Coulter initiated a design change to update the Automate PC image to accommodate the oper... Class III Beckman Coulter Inc.
Dec 19, 2016 MiniLoc¿ Safety Infusion Set Winged without Y-Injection Site. Product Code: S... Bard Access Systems announces a voluntary field action for the SafeStep¿ Huber Needle Set with Y-... Class II Bard Access Systems
Dec 19, 2016 SafeStep¿ Huber Needle Set with Y-Injection Site. Product Code: LH-0029YN. Pa... Bard Access Systems announces a voluntary field action for the SafeStep¿ Huber Needle Set with Y-... Class II Bard Access Systems

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.