Browse Device Recalls

3,664 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,664 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 3,664 FDA device recalls, Class I.

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DateProductReasonClassFirm
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
May 17, 2016 AVEA GDE/UIM upgrade kit, 12283-PMN A continuous ventilator intended to mech... 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)-1st Generation, 16222-001-99 A continuous ventilat... 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, 17312-xx (xx = 0 - 14) A continuo... 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 GDE upgrade kit, 12284-PMN A continuous ventilator intended to mechanic... 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-refurbished, R17311-xx (xx = 0-14) A continuous ven... 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 Comprehensive ventilator, 17310-xx (xx = 0 - 14) A continuous ventila... 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 Comprehensive ventilator-refurbished, R17310-xx (xx = 0-14) A continuo... CareFusion has identified a potential risk associated with AVEA Ventilator caused by an incorrect... Class I Carefusion 211 Inc dba Carefusion
Apr 13, 2016 Battery Pack Used with the Capnostream"20 and Capnostream"20p Patient Monitor... Medtronic Respiratory & Monitoring Solutions Announces a Voluntary Recall of a Battery Pack Used ... Class I Medtronic
Apr 1, 2016 Dialog+ Hemodialysis machines: Dialog A + 1 Blood Pump 120V Product Code 710... Potential leakage of conductivity sensors of the Dialog Dialysis machines. Class I B Braun Medical Inc
Apr 1, 2016 Dialog+ Hemodialysis machines: Dialog + 120 V DF+Adimea+WAN-BSL-BIC Product ... Potential leakage of conductivity sensors of the Dialog Dialysis machines. Class I B Braun Medical Inc
Apr 1, 2016 Dialog+ Hemodialysis machines: Conductivity Sensor (BIC) Item 3456103A The D... Potential leakage of conductivity sensors of the Dialog Dialysis machines. Class I B Braun Medical Inc
Apr 1, 2016 Dialog+ Hemodialysis machines: Dialog + 120 V DF+Adimea+WAN-BSL Product Code... Potential leakage of conductivity sensors of the Dialog Dialysis machines. Class I B Braun Medical Inc
Apr 1, 2016 Dialog+ Hemodialysis machines: Conductivity Sensor (BIC) Item # 3456102A The... Potential leakage of conductivity sensors of the Dialog Dialysis machines. Class I B Braun Medical Inc
Apr 1, 2016 Dialog+ Hemodialysis machines: Dialog A + HE/BIC Product Code 710200L Seria... Potential leakage of conductivity sensors of the Dialog Dialysis machines. Class I B Braun Medical Inc
Mar 25, 2016 NeuroBlate System SideFire Select 2.2 mm Directional Laser Probe, Sterile EO... Monteris received a report that the sapphire lens on a 2.2SF probe fractured during a LITT proced... Class I Monteris Medical Corp

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.