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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

3,013 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,013 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 3,013 FDA device recalls in 2018.

Clear
DateProductReasonClassFirm
May 10, 2018 RS TANDEM 5F DL BIOFLO PICC, Catalog Number 60M250097 A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). Class II Angiodynamics Inc. (Navilyst Medical Inc.)
May 10, 2018 BioFlo PICC (NV) 5FDL-55cm Maximal Barrier Nursing Kit w/70cm Nitinol Wire PG... A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). Class II Angiodynamics Inc. (Navilyst Medical Inc.)
May 10, 2018 Rio System Irrigation Clip - Catalog # 111690 Product Usage: The RESTORIS... Out of tolerance. Class II Mako Surgical Corporation
May 10, 2018 Bio-Stable 5F DL-55CM MST-70 KIT Non-Valved with Nitinol Guidewire PG, Catalo... A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). Class II Angiodynamics Inc. (Navilyst Medical Inc.)
May 10, 2018 microTargeting" STar" Drive System (Motorized), Product Number ST-DS-ME The FHC Depth Stop Adapter may cause damage to the lead and stylet when the depth stop screw is o... Class II FHC, Inc.
May 10, 2018 RS 5F DL XPP, Catalog Number 60M030393 A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). Class II Angiodynamics Inc. (Navilyst Medical Inc.)
May 10, 2018 BioFlo PICC (Valved) 5FDL-55cm Maximal Barrier Nursing Kit w/70cm Nitinol Wir... A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). Class II Angiodynamics Inc. (Navilyst Medical Inc.)
May 10, 2018 RS TANDEM 5F DL BIOFLO PASV, Catalog Number 60M120196 A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). Class II Angiodynamics Inc. (Navilyst Medical Inc.)
May 10, 2018 Bio-Stable 5F SL-55CM IR-145 Kit Non-Valved with Nitinol GW PG, Catalog Numbe... A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). Class II Angiodynamics Inc. (Navilyst Medical Inc.)
May 10, 2018 TANDEM 5F DL BIOFLO PASV, Catalog Number 60M140567 A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). Class II Angiodynamics Inc. (Navilyst Medical Inc.)
May 10, 2018 BioFlo PICC (Valved) 5FDL-55cm Maximal Barrier Nursing Kit PG, Catalog Number... A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). Class II Angiodynamics Inc. (Navilyst Medical Inc.)
May 10, 2018 RS 5F DL XCELA PICC, Catalog Number 60M122272 A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). Class II Angiodynamics Inc. (Navilyst Medical Inc.)
May 10, 2018 Gibco RPMI 1640 Medium, Model Number 61870150. Tissue and cell culture medium. It has been determined that the fill port tube seal integrity was compromised during the manufact... Class II Life Technologies, Corp.
May 10, 2018 Bio-Stable 5F SL-55CM IR-145 Kit Valved PG, Catalog Number 45-818 A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). Class II Angiodynamics Inc. (Navilyst Medical Inc.)
May 10, 2018 RS TANDEM 5F DL BIOFLO PASV, Catalog Number 60M232242 A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). Class II Angiodynamics Inc. (Navilyst Medical Inc.)
May 10, 2018 microTargeting" STar" Drive System (Motorized), Product Number 70-ZD-ME The FHC Depth Stop Adapter may cause damage to the lead and stylet when the depth stop screw is o... Class II FHC, Inc.
May 10, 2018 RS - TANDEM 5F DL BIOFLO MIDLINE, Catalog Number 60M035472 A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). Class II Angiodynamics Inc. (Navilyst Medical Inc.)
May 10, 2018 RS 5F DL BIOFLO PASV, Catalog Number 60M183481 A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). Class II Angiodynamics Inc. (Navilyst Medical Inc.)
May 10, 2018 Gibco Dulbecco's Modified Eagle Medium (DMEM), high glucose, pyruvate, Model ... It has been determined that the fill port tube seal integrity was compromised during the manufact... Class II Life Technologies, Corp.
May 10, 2018 Gibco Dulbecco's Modified Eagle Medium (DMEM), high glucose, pyruvate, Model ... It has been determined that the fill port tube seal integrity was compromised during the manufact... Class II Life Technologies, Corp.
May 10, 2018 CAN 5F DL BIOFLO PASV PICC NURSING TRAY, Catalog Number 60M700936 A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). Class II Angiodynamics Inc. (Navilyst Medical Inc.)
May 10, 2018 microTargeting" Drive System Distributed by Medtronic, Product Number FC1006 The FHC Depth Stop Adapter may cause damage to the lead and stylet when the depth stop screw is o... Class II FHC, Inc.
May 10, 2018 Bio-Stable 5F SL-55CM MST-70 Kit Valved with Nitinol Guidewire PG, Catalog Nu... A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). Class II Angiodynamics Inc. (Navilyst Medical Inc.)
May 10, 2018 microTargeting" Drive System, Product Number 66-ZD-MD-01 The FHC Depth Stop Adapter may cause damage to the lead and stylet when the depth stop screw is o... Class II FHC, Inc.
May 10, 2018 microTargeting" Lead Adapter for STar" Drive, Product Number 70-CN-DB The FHC Depth Stop Adapter may cause damage to the lead and stylet when the depth stop screw is o... Class II FHC, Inc.
May 10, 2018 RS 5F DL XPP KIT, Catalog Number 60M183104 A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). Class II Angiodynamics Inc. (Navilyst Medical Inc.)
May 10, 2018 Bio-Stable 5F DL-55CM IR-145 Kit Non-Valved with Nitinol GW PG, Catalog Numbe... A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). Class II Angiodynamics Inc. (Navilyst Medical Inc.)
May 10, 2018 microTargeting" STar" Drive System (Manual) Distributed by Medtronic, Product... The FHC Depth Stop Adapter may cause damage to the lead and stylet when the depth stop screw is o... Class II FHC, Inc.
May 10, 2018 Bio-Stable 5F SL-55CM IR-145 Kit Valved with Nitinol GW PG, Catalog Number 45... A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). Class II Angiodynamics Inc. (Navilyst Medical Inc.)
May 10, 2018 XCELA PASV 5F SL 55CM IR-145 Nitinol Wire KIT PG, Catalog Number 25-124 A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). Class II Angiodynamics Inc. (Navilyst Medical Inc.)
May 10, 2018 Gibco CTS OpTmizer T Cell Expansion Serum Free Medium, bag format, Model Numb... It has been determined that the fill port tube seal integrity was compromised during the manufact... Class II Life Technologies, Corp.
May 10, 2018 Bio-Stable 5F DL-55CM MST-70 KIT Non-Valved PG, Catalog Number 45-871 A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). Class II Angiodynamics Inc. (Navilyst Medical Inc.)
May 10, 2018 microTargeting" Drive System Distributed by Medtronic, Product Number 9033G0601 The FHC Depth Stop Adapter may cause damage to the lead and stylet when the depth stop screw is o... Class II FHC, Inc.
May 10, 2018 medfusion Stopcock, 1-way and 4-way, Model Numbers (REF): a. 081-101BE b. 0... Product has a lack of sterility assurance Class II Smiths Medical ASD Inc.
May 10, 2018 microTargeting" Lead Adapter for microTargeting" Drive, Product Number 66-CN-DB The FHC Depth Stop Adapter may cause damage to the lead and stylet when the depth stop screw is o... Class II FHC, Inc.
May 10, 2018 BioFlo Midline 5F DL-20cm Max Sterile Barrier Drape Kit w/ Two Nitinol Guidew... A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). Class II Angiodynamics Inc. (Navilyst Medical Inc.)
May 10, 2018 RS 5F DL BIOFLO PICC, Catalog Number 60M071831 A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). Class II Angiodynamics Inc. (Navilyst Medical Inc.)
May 10, 2018 RS 5F DL BIOFLO PASV, Catalog Number 60M181578 A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). Class II Angiodynamics Inc. (Navilyst Medical Inc.)
May 10, 2018 microTargeting" STar" Drive System (Motorized) Distributed by Medtronic, Prod... The FHC Depth Stop Adapter may cause damage to the lead and stylet when the depth stop screw is o... Class II FHC, Inc.
May 10, 2018 Bio-Stable 5F DL-55CM IR-145 Kit Non-Valved PG, Catalog Number 45-872 A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). Class II Angiodynamics Inc. (Navilyst Medical Inc.)
May 10, 2018 microTargeting" Drive System, Product Number MT-DS-01 The FHC Depth Stop Adapter may cause damage to the lead and stylet when the depth stop screw is o... Class II FHC, Inc.
May 10, 2018 Outer Package Label: Tapered Screw-Vent Implant System, 4.1mm X 10mm, 3.5mm, ... Dental implants have incorrect item/lot numbers and size on the inner package labeling. Correct i... Class II Zimmer Dental Inc
May 10, 2018 microtargeting" Depth Stop Adapter, Product Model Number, Product Number 66-A... The FHC Depth Stop Adapter may cause damage to the lead and stylet when the depth stop screw is o... Class II FHC, Inc.
May 10, 2018 Xcela 5FDL-55cm Maximal Barrier Nursing Kit PG, Catalog Number 75-003 A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). Class II Angiodynamics Inc. (Navilyst Medical Inc.)
May 10, 2018 RS 5F DL BIOFLO PASV, Catalog Number 60M150373 A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). Class II Angiodynamics Inc. (Navilyst Medical Inc.)
May 10, 2018 RS TANDEM 5F DL XCELA PICC PASV, Catalog Number 60M181582 A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). Class II Angiodynamics Inc. (Navilyst Medical Inc.)
May 10, 2018 Gibco Dulbecco's Modified Eagle Medium (DMEM), high glucose, Model Number 119... It has been determined that the fill port tube seal integrity was compromised during the manufact... Class II Life Technologies, Corp.
May 10, 2018 CAN 5F DUAL XCELA PICC, Catalog Number 60M701532 A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). Class II Angiodynamics Inc. (Navilyst Medical Inc.)
May 10, 2018 GIBCO CTS AIM V Serum-Free Media (SFM), Model Number 0870112BK. Tissue and c... It has been determined that the fill port tube seal integrity was compromised during the manufact... Class II Life Technologies, Corp.
May 10, 2018 BioFlo PICC (NV) 5FSL-55cm Maximal Barrier Nursing Kit w/ 70cm Nitinol Wire P... A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). Class II Angiodynamics Inc. (Navilyst Medical 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.