Browse Device Recalls

3,629 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,629 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 3,629 FDA device recalls, Class I.

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DateProductReasonClassFirm
Oct 10, 2016 Fortify VR, Model No. CD1231-40, CD1231-40Q. Fortify ST VR, Model No. CD1241... St Jude Medical is recalling implantable cardiac defibrillator (ICD) and cardiac resynchronizatio... Class I St Jude Medical Inc.
Oct 5, 2016 Pipeline Embolization Device (Pipeline Classic) The device is indicated for ... Delamination and detachment of the PTFE (polytetrafluoroethylene) coating material may lead to PT... Class I Micro Therapeutics Inc, Dba Ev3 Neurovascular
Oct 5, 2016 Alligator Retrieval Device The device is intended for use in the peripheral ... Delamination and detachment of the PTFE (polytetrafluoroethylene) coating material may lead to PT... Class I Micro Therapeutics Inc, Dba Ev3 Neurovascular
Oct 5, 2016 X-Celerator Hydrophilic Exchange Guidewire Catalog No. 103-0601-300 103-... Delamination and detachment of the PTFE (polytetrafluoroethylene) coating material may lead to PT... Class I Micro Therapeutics Inc, Dba Ev3 Neurovascular
Oct 5, 2016 Marathon Flow Directed Micro Catheter, UltraFlow HPC Flow Directed Micro Cath... Delamination and detachment of the PTFE (polytetrafluoroethylene) coating material may lead to PT... Class I Micro Therapeutics Inc, Dba Ev3 Neurovascular
Oct 4, 2016 Normal Saline Flush 0.9% USP Sodium Chloride Injection Syringe, 3 ml fill, 5 ... Potential contamination with B. cepacia. Class I Nurse Assist, Inc
Oct 3, 2016 Medtronic SynchroMed II Implantable Drug Infusion System. This system includ... Medtronic is following up to a May 2013 communication regarding the Priming Bolus function for th... Class I Medtronic Neuromodulation
Sep 29, 2016 FindrWIRZ Guidewire System Catalog# 40-05 Cardiology: The system is inten... A complaint was received on September 27th, 2016 at a medical center in Germany for delamination ... Class I SentreHeart Inc
Sep 16, 2016 Vascular Solutions Twin-Pass .023" Dual Access Catheter, model 5230. Sterili... Vascular Solutions is recalling Twin-Pass dual access catheters because there is a potential for... Class I Vascular Solutions, Inc.
Sep 16, 2016 Vascular Solutions Twin-Pass RX Dual Access Catheter, model 5210. Sterilized... Vascular Solutions is recalling Twin-Pass dual access catheters because there is a potential for... Class I Vascular Solutions, Inc.
Sep 16, 2016 Vascular Solutions Twin-Pass Dual Access Catheter, models 5200, 5210, and 523... Vascular Solutions is recalling Twin-Pass dual access catheters because there is a potential for... Class I Vascular Solutions, Inc.
Sep 1, 2016 Skintact Electrodes for Defibrillation, DF29N. Product Usage: Multifuncti... There is a risk that defibrillation electrodes model DF29N will be connected with the defibrillat... Class I Leonhard Lang Medizintechnik GmbH
Aug 26, 2016 Willy Rusch GmbH Tracheostomy Tube Set Cannulation of tracheotomised patie... The connector may disconnect from the tracheostomy tube during use. Class I Teleflex Medical
Aug 24, 2016 0.2 Micron Filter, 50 mm Product Usage: The 0.2 Micron Filter is a bacter... Baxter Healthcare Corporation is issuing a voluntary product recall for all unexpired lots of the... Class I Baxter Corporation Englewood
Aug 17, 2016 HeartWare Ventricular Assist System (HVAD), US product: Model No.: 1103; and... Foreign material found within the driveline connector of the HVAD Pump that could cause increased... Class I HeartWare, Inc
Aug 2, 2016 Greatbatch, Offset Cup Impactor with the following Parts and Catalogue #: T... On December 17, 2015, Greatbatch discovered that the Standard Offset Cup Impactor with a POM-C ha... Class I Greatbatch Medical
Jul 20, 2016 OraQuick Ebola Rapid Antigen Test, Product Code 3001-2807; Intended for th... Failed stability testing at 8 months. This lot produced intermittent false negative results for ... Class I OraSure Technologies, Inc.
Jul 11, 2016 Alere INRatio PT/INR Test Strips Model Number: 0100071, 0100139 Product U... Alere San Diego is initiating a voluntary recall for the Alere INRatio¿/INRatio¿2 PT/INR Monitori... Class I Alere San Diego, Inc.
Jul 11, 2016 Alere INRatio2 Replacement Monitor (Home) Model Number: 0200457 Product U... Alere San Diego is initiating a voluntary recall for the Alere INRatio¿/INRatio¿2 PT/INR Monitori... Class I Alere San Diego, Inc.
Jul 11, 2016 Alere INRatio2 PT/INR Professional Monitoring System Model Number: 55128A ... Alere San Diego is initiating a voluntary recall for the Alere INRatio¿/INRatio¿2 PT/INR Monitori... Class I Alere San Diego, Inc.
Jul 11, 2016 Alere INRatio/ INRatio2 PT/INR Test Strips Model Number: 99007EU, 99007G1, 9... Alere San Diego is initiating a voluntary recall for the Alere INRatio¿/INRatio¿2 PT/INR Test Str... Class I Alere San Diego, Inc.
Jul 11, 2016 Alere INRatio2 PT/INR Professional Testing System Model Number: 0200431 P... Alere San Diego is initiating a voluntary recall for the Alere INRatio¿/INRatio¿2 PT/INR Monitori... Class I Alere San Diego, Inc.
Jul 11, 2016 Alere INRatio Replacement Monitor Model Number: 0100137 Usage: The INRa... Alere San Diego is initiating a voluntary recall for the Alere INRatio¿/INRatio¿2 PT/INR Monitori... Class I Alere San Diego, Inc.
Jul 11, 2016 INRatio Prothrombin Time (PT) Monitoring System Model Number: 0100007 Pr... Alere San Diego is initiating a voluntary recall for the Alere INRatio¿/INRatio¿2 PT/INR Monitori... Class I Alere San Diego, Inc.
Jul 11, 2016 Alere INRatio2 PT/INR Home Monitoring System Model Number: 0200432, 0200433 ... Alere San Diego is initiating a voluntary recall for the Alere INRatio¿/INRatio¿2 PT/INR Monitori... Class I Alere San Diego, Inc.
Jul 11, 2016 Alere INRatio PT/INR System Professional Model Numbers: 0100004 Product U... Alere San Diego is initiating a voluntary recall for the Alere INRatio¿/INRatio¿2 PT/INR Monitori... Class I Alere San Diego, Inc.
Jul 8, 2016 NucliSENS easyMAG Magnetic Silica The NucliSENS easyMAG accessory products... Several customer complaints about amplification performance issues when using different batches o... Class I BioMerieux SA
Jul 1, 2016 DIAMOND-FLEX CIRCULAR RETRACTOR, ANGLED, 40MM 5MM, Product Code 89-6114, Lot ... BD, formerly CareFusion, has identified a potential risk associated with a weld failure which cou... Class I Carefusion 2200 Inc
Jun 24, 2016 Light Adaptor for Small Battery Drive and Small Battery Drive II. There was a potential for the Adaptor and Light Adaptor for Small Battery Drive and Small Battery... Class I The Anspach Effort, Inc.
Jun 24, 2016 Adaptor for Small Battery Drive and Small Battery Drive II. Product Usage:... There was a potential for the Adaptor and Light Adaptor for Small Battery Drive and Small Battery... Class I The Anspach Effort, Inc.
Jun 24, 2016 Roadrunner Uniglide Hydrophilic Wire Guide, Catalog Numbers and GPN: HPWA-18-... Potential coating contamination with glass particles. Class I Cook Inc.
Jun 21, 2016 ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA... ADVANCE(R) HA Coated tibial bases are being recalled due to a higher than expected revision rate ... Class I MicroPort Orthopedics Inc.
Jun 21, 2016 ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA... ADVANCE(R) HA Coated tibial bases are being recalled due to a higher than expected revision rate ... Class I MicroPort Orthopedics Inc.
Jun 21, 2016 ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA... ADVANCE(R) HA Coated tibial bases are being recalled due to a higher than expected revision rate ... Class I MicroPort Orthopedics Inc.
Jun 21, 2016 ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA... ADVANCE(R) HA Coated tibial bases are being recalled due to a higher than expected revision rate ... Class I MicroPort Orthopedics Inc.
Jun 21, 2016 ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA... ADVANCE(R) HA Coated tibial bases are being recalled due to a higher than expected revision rate ... Class I MicroPort Orthopedics Inc.
Jun 21, 2016 ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA... ADVANCE(R) HA Coated tibial bases are being recalled due to a higher than expected revision rate ... Class I MicroPort Orthopedics Inc.
Jun 21, 2016 ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA... ADVANCE(R) HA Coated tibial bases are being recalled due to a higher than expected revision rate ... Class I MicroPort Orthopedics Inc.
Jun 21, 2016 ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA... ADVANCE(R) HA Coated tibial bases are being recalled due to a higher than expected revision rate ... Class I MicroPort Orthopedics Inc.
Jun 21, 2016 ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA... ADVANCE(R) HA Coated tibial bases are being recalled due to a higher than expected revision rate ... Class I MicroPort Orthopedics Inc.
Jun 21, 2016 ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA... ADVANCE(R) HA Coated tibial bases are being recalled due to a higher than expected revision rate ... Class I MicroPort Orthopedics Inc.
Jun 21, 2016 ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA... ADVANCE(R) HA Coated tibial bases are being recalled due to a higher than expected revision rate ... Class I MicroPort Orthopedics Inc.
Jun 8, 2016 HeartWare Ventricular Assist System Controller Product Usage: For use as... Loose connector ports in controller body. Class I Heartware, Inc.
Jun 1, 2016 AngioDynamics Soft Vu Omni Flush Angiographic Catheter Model Number: 10732203 Product defect; tip of two (2) Angiographic Catheters model # 10732203 broke off, prior to being... Class I Stryker Sustainability Solutions
May 31, 2016 Oxylog 3000, Disposable Pediatric Patient Circuit, Catalog Number: 5704964 ... Isolated episodes of leakage at the check valve were found Class I Draeger Medical, Inc.
May 17, 2016 Gas Delivery Engine (GDE), 16650A A continuous ventilator intended to mechan... CareFusion has identified a potential risk associated with AVEA Ventilator caused by an incorrect... Class I Carefusion 211 Inc dba Carefusion
May 17, 2016 Gas Delivery Engine (GDE)-refurbished, R16650A A continuous ventilator inten... CareFusion has identified a potential risk associated with AVEA Ventilator caused by an incorrect... Class I Carefusion 211 Inc dba Carefusion
May 17, 2016 TCA Board, 16542A A continuous ventilator intended to mechanically control o... CareFusion has identified a potential risk associated with AVEA Ventilator caused by an incorrect... Class I Carefusion 211 Inc dba Carefusion
May 17, 2016 AVEA Standard with Compressor ventilator-refurbished, R17312-xx (xx = 0-14) ... CareFusion has identified a potential risk associated with AVEA Ventilator caused by an incorrect... Class I Carefusion 211 Inc dba Carefusion
May 17, 2016 AVEA Standard ventilator, 17311-xx (xx = 0 - 14) A continuous ventilator in... CareFusion has identified a potential risk associated with AVEA Ventilator caused by an incorrect... Class I Carefusion 211 Inc dba Carefusion

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.