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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

5,428 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 5,428 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 5,428 FDA device recalls.

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DateProductReasonClassFirm
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
Dec 16, 2016 Covidien Nellcor SpO2 Forehead Sensor Item Code: RS10; The Covidien Nellc... Labeling error: The label indicates the product is latex free, but the headband component include... Class II Covidien LLC
Dec 16, 2016 Orthopedic Salvage System (OSS) 9cm prosthesis, knee, femorotibial, constrai... labeling for specific lots of the Standard OSS Modular Proximal Tibia incorrectly identifies the ... Class II Zimmer Biomet, 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 9, 2016 Smiths Medical CADD Blue-Striped IV Administration Set, REF 21-7036-01, Steri... The label of the CADD Blue-Striped Administrative Set is missing the expiration date, which is co... Class II Smiths Medical ASD Inc.
Dec 7, 2016 DIAMONDBACK 360 Peripheral 1.50 Classic, Model DBP-150CLASS145 Peripheral Or... CSI discovered that a 1.50mm Solid Crown OAD was labeled as a 1.50mm Crown OED. Class II Cardiovascular Systems Inc
Dec 6, 2016 Oxford Fixed Lateral Bearing Size F Right, Part Number 154375 Lot 744260, Ste... Zimmer Biomet is initiating a removal of a single lot of Oxford Fixed Lateral Bearings due to mis... Class II Zimmer Biomet, Inc.
Dec 5, 2016 EnLite Neonatal TREC Kit;an in vitro diagnostic device intended for the semi-... Unique Device Identifier (UDI) is missing from outer kit box label. Class III PerkinElmer Health Sciences, Inc.
Nov 30, 2016 Ecolab, Microtek Rolled Probe Cover PC0907NB, Rx Only. The reason for the recall is that the inner carton box of the Rolled Probe Cover PC0907NB has the... Class III Ecolab Inc
Nov 28, 2016 GoDirect Screw-Retaining Top Part Numbers: 4500-61 Consignees received product 6060-62, Replant Overdenture Abutment with the label for 4500-61 GoDi... Class II Implant Direct Sybron Manufacturing, LLC
Nov 23, 2016 i.v. Station and i.v. Station ONCO Automated Drug Compounding System, Pharmac... The firm has initiated a product correction due to a bag carousel motor error causing misalignmen... Class II HEALTH ROBOTICS S.R.L.
Nov 22, 2016 Durex Pleasure Pack . 3 ultra fine lubricated latex condoms 12 ultra fine l... Reckitt Benckiser LLC is recalling Durex Condoms Pleasure Packs due to missing information on the... Class II Reckitt Benckiser LLC
Nov 22, 2016 RUSCH, Pocket PAC IC Intermittent Cath Kit, 8 FR, 12 FR, 14 FR, 10 FR and 16 ... Labeling Inconsistency: The products have been labeled with the incorrect expiration date which ... Class II Teleflex Medical
Nov 22, 2016 Zeus-P Lumbar Interbody Device Labeling error where three boxes in inventory had conflicting patient and primary labels. Evaluat... Class II Amendia, Inc
Nov 18, 2016 OrthoPediatrics PediNail Intramedullary Nailing System 4.5mm X 48mm Cortical... Labeled as a 48mm Cortical Screw but measuring at 50mm Class III OrthoPediatrics Corp
Nov 17, 2016 UltraSeal XT Plus Clear Refill. The package contains 4x 1.2 ml UltraSeal XT ... There was a labeling error with product, UltraSeal XT Plus Clear Refill, Part Number (PN) 565, Lo... Class II Ultradent Products, 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.