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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

3,164 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,164 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 3,164 FDA device recalls.

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DateProductReasonClassFirm
Feb 22, 2021 AngioDynamics Safe Sheath Ultralite - Vascular Introducer/Catheter Introducer... AngioDynamics, Inc. is recalling a specific batch of AngioDynamics Implantable Infusion Port kits... Class II Angiodynamics Inc. (Navilyst Medical Inc.)
Feb 12, 2021 PLEUR-EVAC Thoracic Catheters (CATHETER, IRRIGATION). The thoracic catheter i... Teleflex is recalling this product due to a lack of assurance of sterility. Class II TELEFLEX MEDICAL INC
Jan 15, 2021 Medtronic 6F Launcher Guide Catheter 100 cmJL 3.5 Model Number: LA6JL35 Sterility may be compromised due to an unsealed pouch Class II Medtronic Vascular
Jan 15, 2021 Medtronic 6F Launcher Guide Catheter 100 cm JR 4.0 Model Number: LA6JR40 Sterility may be compromised due to an unsealed pouch Class II Medtronic Vascular
Jan 15, 2021 Medtronic 6F Launcher Guide Catheter 100cm EBU 3.75 Model Number: LA6EBU375 Sterility may be compromised due to an unsealed pouch Class II Medtronic Vascular
Jan 15, 2021 Medtronic 6F Launcher Guide Catheter 100 cm EBU 3.0 Model Number: LA6EBU30 Sterility may be compromised due to an unsealed pouch Class II Medtronic Vascular
Jan 4, 2021 Ethicon Dermabond Advanced Topical Skin Adhesive-topical skin adhesive to hol... Product distributed with a red tape as part of the sterile packaging which could impact the seal ... Class II Ethicon, Inc.
Dec 23, 2020 BD Hypodermic Syringe 10 ml, eccentric tip. Catalog (Ref No.) 305482 The product packaging for the 10 ml eccentric tip syringe may exhibit open seals. An open seal i... Class II Becton Dickinson & Company
Dec 8, 2020 Medtronic Ares Antibiotic-Impregnated Catheter, REF: 93092, Sterile, Rx Only.... There is a potential for a defect on the seal of the outer pouch of catheters. The defect may com... Class II Medtronic Neurosurgery
Dec 8, 2020 Medtronic Ares Antibiotic-Impregnated Catheter, REF: 91101, Sterile, Rx Only.... There is a potential for a defect on the seal of the outer pouch of catheters. The defect may com... Class II Medtronic Neurosurgery
Dec 8, 2020 Medtronic Ares Antibiotic-Impregnated Catheter, REF: 95001, Sterile, Rx Only.... There is a potential for a defect on the seal of the outer pouch of catheters. The defect may com... Class II Medtronic Neurosurgery
Nov 25, 2020 RapidFire Clip, Item Number 95-0154 - Product Usage: Fixation of Craniofaci... Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach... Class II Biomet, Inc.
Nov 25, 2020 RingLoc+ Quick Connect Drill Bit, Item numbers 31-323215, 31-323220, 31-323... Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach... Class II Biomet, Inc.
Nov 25, 2020 Titanium IFS, Item number 909680 - Product Usage: Bone to bone fixation. Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach... Class II Biomet, Inc.
Nov 25, 2020 6.5/8.0mm Cannulated Screw System, BCS Cannulated Screw System (3.0, 4.0/5.0,... Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach... Class II Biomet, Inc.
Nov 25, 2020 RINGLOC ACETABULAR SYSTEM Self-tapping bone screws, Item numbers 103531, 1035... Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach... Class II Biomet, Inc.
Nov 25, 2020 4.0/5.0mm Cannulated Screw System, BCS Cannulated Screw System (3.0, 4.0/5.0,... Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach... Class II Biomet, Inc.
Nov 25, 2020 Comprehensive Reverse Shoulder System, Item numbers 115394, 115395, 115396, 1... Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach... Class II Biomet, Inc.
Nov 25, 2020 RINGLOC BIPOLAR Hip System Bi Polar Locking Ring, Item number 11-165304 - Pro... Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach... Class II Biomet, Inc.
Nov 25, 2020 OSS Polyethylene Tibial Bushing, Item number 150476 - Product Usage: intended... Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach... Class II Biomet, Inc.
Nov 25, 2020 M/H MODULAR STEM, Item number 13-104756 - Product Usage: intended for use in ... Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach... Class II Biomet, Inc.
Nov 25, 2020 PHOENIX, Interlocking screw for IM nail, Item numbers 14-405040, 14-405042, 1... Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach... Class II Biomet, Inc.
Nov 25, 2020 Sterile Trac System Thinflap 24 MM Burr Hole Plate, Item number SP-STA-1021-1... Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach... Class II Biomet, Inc.
Nov 25, 2020 Custom Cancellous Thread, Item numbers CP161941, CP161943 - Product Usage: ... Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach... Class II Biomet, Inc.
Nov 25, 2020 Oxford Fixed Lateral, Item numbers 154330, 154370, 154373 154376 - Product U... Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach... Class II Biomet, Inc.
Nov 25, 2020 Comprehensive Total Shoulder System/Bio-Modular Choice Shoulder System, Item ... Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach... Class II Biomet, Inc.
Nov 25, 2020 3.0mm Cannulated Screw System, BCS Cannulated Screw System (3.0, 4.0/5.0, 6.5... Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach... Class II Biomet, Inc.
Nov 20, 2020 HLS Set Advanced, Model: BEQ-HLS 7050 USA; HLS Set Advanced 7.0 Product Code/... The HLS Set Advanced (disposable for Cardiohelp) is being recalled due to breaches in the product... Class II Maquet Cardiovascular Us Sales, Llc
Nov 20, 2020 HLS Set Advanced Model Name: BEQ-HLS 5050 USA; HLS Set Advanced 5.0, Product ... The HLS Set Advanced (disposable for Cardiohelp) is being recalled due to breaches in the product... Class II Maquet Cardiovascular Us Sales, Llc
Aug 26, 2020 EVOLVE STEM 8.5MM Model # 496S085 Lack of sterility assurance Class II Wright Medical Technology Inc
Aug 21, 2020 4 In. Flat Responder Emergency Trauma Dressing part number 30-0171, packaged ... Lack of sterility assurance of the 30-0171 Class II North American Rescue LLC.
Aug 12, 2020 Central Line Dressing Change Tray Potential of incomplete seals impacting the sterility of the kit. Class II Medline Industries Inc
Aug 7, 2020 Pleur-evac Thoracic Catheters Catalog No: DTRC-20S The thoracic catheter ... Potential sterility issue Class II TELEFLEX MEDICAL INC
Jul 6, 2020 Arrow TheraCath Epidural Catheter - Product Usage: The Arrow Epidural Cathete... The lidstock states the incorrect expiration date for the product. This issue could result in use... Class II Arrow International Inc
Jul 6, 2020 Arrow Single Shot Epidural Anesthesia Kit - Product Usage: The Arrow Blunt Ne... The lidstock states the incorrect expiration date for the product. This issue could result in use... Class II Arrow International Inc
Jul 6, 2020 NextStep Retrograde Replacement Hub Set - Product Usage: is indicated for use... The lidstock states the incorrect expiration date for the product. This issue could result in use... Class II Arrow International Inc
Jul 6, 2020 Cannon II Plus Replacement Hub Set - Product Usage: is indicated for use in t... The lidstock states the incorrect expiration date for the product. This issue could result in use... Class II Arrow International Inc
Jul 6, 2020 Gentueri Viral Transport Medium Kit with 8cm Breakpoint Swab Kits failed sterility testing and showed evidence of contamination. Class II Gentueri Inc
May 27, 2020 Prodimed Combicath catheters for blind or fibrescope-guided protected distal ... Lack of assurance of sterility Class II Prodimed Plastimed Division
May 27, 2020 Prodimed Combicath Paediatric catheters for blind protected distal bronchial ... Lack of assurance of sterility Class II Prodimed Plastimed Division
May 27, 2020 Prodimed Combicath catheters for blind or fibrescope-guided protected distal ... Lack of assurance of sterility Class II Prodimed Plastimed Division
May 27, 2020 Prodimed Combicath catheters for mini bronchoalveolar lavage (BAL)-COMBICATH ... Lack of assurance of sterility Class II Prodimed Plastimed Division
May 27, 2020 Prodimed Combicath Paediatric catheters for blind protected distal bronchial ... Lack of assurance of sterility Class II Prodimed Plastimed Division
May 27, 2020 Prodimed Combicath catheters for mini bronchoalveolar lavage (BAL)-COMBICATH ... Lack of assurance of sterility Class II Prodimed Plastimed Division
May 7, 2020 Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x45 mm Catalog Number: 1896... Seal integrity of the blister pack may be compromised and sterility cannot be assured Class II Stryker GmbH
May 7, 2020 Stryker End Cap, Standard T2 Humerus ¿6 mm Catalog Number: 18300003S - Pro... Seal integrity of the blister pack may be compromised and sterility cannot be assured Class II Stryker GmbH
May 7, 2020 Stryker Locking Screw, Fully Threaded S2 05x35 mm Catalog Number: 17965035S ... Seal integrity of the blister pack may be compromised and sterility cannot be assured Class II Stryker GmbH
May 7, 2020 Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x35 mm Catalog Number: 1896... Seal integrity of the blister pack may be compromised and sterility cannot be assured Class II Stryker GmbH
May 7, 2020 Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x50 mm Catalog Number: 1896... Seal integrity of the blister pack may be compromised and sterility cannot be assured Class II Stryker GmbH
May 7, 2020 Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x30 mm Catalog Number: 18... Seal integrity of the blister pack may be compromised and sterility cannot be assured Class II Stryker GmbH

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.