Browse Device Recalls

2,602 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,602 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 2,602 FDA device recalls in 2020.

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DateProductReasonClassFirm
Feb 5, 2020 IMMULITE 1000 Systems E2 Estradiol Catalog #: US: LKE21(D) and OUS: LKE21 - ... Due to high discordant Estradiol results which.potentially affects all patient populations, A fal... Class II Siemens Healthcare Diagnostics, Inc.
Feb 5, 2020 IMMULITE 2000 Systems E2 Estradiol Catalog #: US: L2KE22(D) (200 tests) and L... Due to high discordant Estradiol results which.potentially affects all patient populations, A fal... Class II Siemens Healthcare Diagnostics, Inc.
Feb 4, 2020 VNS Therapy Programmer, Model 3000 used with Models 103, 104, 105, 106, or 81... False positive warning may occur after: 1) VNS Generator interrogated at 0mA normal output curren... Class II LivaNova USA Inc
Feb 4, 2020 HEMO-10 Hemospray Endoscopic Hemostat Complaints that the handle and/or activation knob on Hemostat devices have cracked or broken when... Class II Wilson-Cook Medical Inc.
Feb 4, 2020 DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the fo... Cardinal Health gowns contain an unknown level of bioburden, unknown microbiological flora, and u... Class II Deroyal Industries, Inc. Lafollette
Feb 4, 2020 HEMO-7 Hemospray Endoscopic Hemostat Complaints that the handle and/or activation knob on Hemostat devices have cracked or broken when... Class II Wilson-Cook Medical Inc.
Feb 4, 2020 DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the fo... Cardinal Health gowns contain an unknown level of bioburden, unknown microbiological flora, and u... Class II Deroyal Industries, Inc. Lafollette
Feb 4, 2020 DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the fo... Cardinal Health gowns contain an unknown level of bioburden, unknown microbiological flora, and u... Class II Deroyal Industries, Inc. Lafollette
Feb 4, 2020 DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the fo... Cardinal Health gowns contain an unknown level of bioburden, unknown microbiological flora, and u... Class II Deroyal Industries, Inc. Lafollette
Feb 4, 2020 DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the fo... Cardinal Health gowns contain an unknown level of bioburden, unknown microbiological flora, and u... Class II Deroyal Industries, Inc. Lafollette
Feb 4, 2020 DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the fo... Cardinal Health gowns contain an unknown level of bioburden, unknown microbiological flora, and u... Class II Deroyal Industries, Inc. Lafollette
Feb 4, 2020 DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the fo... Cardinal Health gowns contain an unknown level of bioburden, unknown microbiological flora, and u... Class II Deroyal Industries, Inc. Lafollette
Feb 4, 2020 DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the fo... Cardinal Health gowns contain an unknown level of bioburden, unknown microbiological flora, and u... Class II Deroyal Industries, Inc. Lafollette
Feb 4, 2020 DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the fo... Cardinal Health gowns contain an unknown level of bioburden, unknown microbiological flora, and u... Class II Deroyal Industries, Inc. Lafollette
Feb 4, 2020 CareFusion Alaris Syringe Module, Model 8110 1)Error 255-XX-XXX results in inability to edit settings 2)Delay options programming may result i... Class I CareFusion 303, Inc.
Feb 4, 2020 CareFusion Alaris Pump Module, Model 8100 1)Error 255-XX-XXX results in inability to edit settings 2)Delay options programming may result i... Class I CareFusion 303, Inc.
Feb 4, 2020 DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the fo... Cardinal Health gowns contain an unknown level of bioburden, unknown microbiological flora, and u... Class II Deroyal Industries, Inc. Lafollette
Feb 4, 2020 CareFusion Alaris PCA Module, Model 8120 1)Error 255-XX-XXX results in inability to edit settings 2)Delay options programming may result i... Class I CareFusion 303, Inc.
Feb 4, 2020 CareFusion Alaris System, Alaris PC unit models 8000 and 8015 (UDI: 108854038... 1)Error 255-XX-XXX results in inability to edit settings 2)Delay options programming may result i... Class I CareFusion 303, Inc.
Feb 3, 2020 iTotal CR Knee Replacement System, Model No. TCR-121-1111-010102, (ITOTAL CR ... A limited number of tibial trays were labeled with an incorrect serial number and were delivered ... Class II Conformis, Inc.
Feb 3, 2020 iTotal PS Knee Replacement System, Model No. TPS-111-1111-010101, (ITOTAL PS ... A limited number of tibial trays were labeled with an incorrect serial number and were delivered ... Class II Conformis, Inc.
Feb 3, 2020 TRUMATCH Orthognathics - Genioplasty Surgical Kit, Add-on, Catalog Number: SD... Custom surgical kits contain a plate different than indicated by the package labeling. Class II Materialise N.V.
Feb 3, 2020 Dexcom G5 Continuous Glucose Monitoring System The Dexcom G4 PLATINUM Cont... The company identified potential interference from hydroxyurea. Patient use of the anti-neoplasti... Class II Dexcom Inc
Feb 3, 2020 ABL90 FLEX Analyzer, Model Numbers 393-090, with software versions below 3.4M... The firm received reports of occurrences where the barcode reader misinterpreted the contents of... Class II Radiometer Medical ApS
Feb 3, 2020 Dexcom G4 PLATINUM Continuous Glucose Monitoring System The Dexcom G4 PLAT... The company identified potential interference from hydroxyurea. Patient use of the anti-neoplasti... Class II Dexcom Inc
Feb 3, 2020 ABL90 FLEX PLUS Analyzer, Model Number 393-092 - Product Usage: It is intende... The firm received reports of occurrences where the barcode reader misinterpreted the contents of... Class II Radiometer Medical ApS
Feb 3, 2020 TRUMATCH Orthognathic - Full Bimaxillary Surgical Kit, Catalog Number SD980.001 Custom surgical kits contain a plate different than indicated by the package labeling. Class II Materialise N.V.
Feb 3, 2020 Dexcom G6 Continuous Glucose Monitoring System The Dexcom G4 PLATINUM Cont... The company identified potential interference from hydroxyurea. Patient use of the anti-neoplasti... Class II Dexcom Inc
Jan 31, 2020 Presource Procedure Packs containing AAMI Level 3 surgical gowns, Multiple Ca... The kits contained recalled surgical gowns. The gowns were manufactured at locations that did not... Class II Cardinal Health 200, LLC
Jan 31, 2020 UST-2265-2 Probe, Part Number: UST-2265-2 - Product Usage: The UST-2265-2 pro... These 18 probes may have mis-wiring in the inner cables, causing decreased sensitivity and thus r... Class II Hitachi Medical Systems America Inc
Jan 31, 2020 STEALTH SPRING CLIP 6mm latis (1/4 Force). Non-Sterile, REF/UDI::A1702/(01)10... Failure of cardiovascular clips to provide sufficient occlusion of the vessel. Class II Applied Medical Resources Corp
Jan 31, 2020 Presource Procedure Packs containing AAMI Level 3 surgical gowns, Multiple Ca... The kits contained recalled surgical gowns. The gowns were manufactured at locations that did no... Class II Cardinal Health 200, LLC
Jan 31, 2020 STEALTH SPRING CLIP 6mm latis (1/2 Force). REF/UDI::A1601/(01)00607915110567 ... Failure of cardiovascular clips to provide sufficient occlusion of the vessel. Class II Applied Medical Resources Corp
Jan 31, 2020 STEALTH SPRING CLIP 6mm latis (1/4 Force). REF/UDI::A1602/(01)00607915110574 ... Failure of cardiovascular clips to provide sufficient occlusion of the vessel. Class II Applied Medical Resources Corp
Jan 31, 2020 LDI Laser firmware lower than V02.13.00 for LDI models: LDl-7, LDI-WF, LDI-... The defect relates to firmware version lower than V02.13.00. It is controlling safety interlocks... Class II 89 NORTH
Jan 31, 2020 STEALTH SPRING CLIP 6mm latis (3/4 Force). REF/UDI::A1603/(01)00607915110581 ... Failure of cardiovascular clips to provide sufficient occlusion of the vessel. Class II Applied Medical Resources Corp
Jan 30, 2020 Medtronic CareLink Encore 29901 Programmer. Used to interrogate and program... Medtronic Conexus Telemetry has been determined to contain two primary cyber vulnerabilities: imp... Class II Medtronic Inc., Cardiac Rhythm and Heart Failur...
Jan 30, 2020 Medtronic CareLink 2090 Programmer. Used to interrogate and program Medtroni... Medtronic Conexus Telemetry has been determined to contain two primary cyber vulnerabilities: imp... Class II Medtronic Inc., Cardiac Rhythm and Heart Failur...
Jan 30, 2020 LKT200 Perfusion Circuit, part of Lifeport Kidney Perfusion Transporter KTR -... Observed leakage at the sample port assembly which could potentially lead to loss of perfusion so... Class II Organ Recovery Systems, Inc.
Jan 29, 2020 NC TREK Coronary Dilatation Catheter, REF 1012453-15 Rx Only, NC TREK RX 4.00... Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon. Class I Abbott Vascular
Jan 29, 2020 NC TREK Coronary Dilatation Catheter, REF 1012455-15 Rx Only,NC TREK RX 5.00 ... Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon. Class I Abbott Vascular
Jan 29, 2020 NC TREK Coronary Dilatation Catheter, REF 1012455-12 Rx Only, NC TREK RX 5.00... Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon. Class I Abbott Vascular
Jan 29, 2020 NC TRAVELER Coronary Dilatation Catheter, REF 1013158-12, Rx Only,NC Traveler... Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon. Class I Abbott Vascular
Jan 29, 2020 NC TREK Coronary Dilatation Catheter, REF 1012453-08 Rx Only, NC TREK RX 4.00... Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon. Class I Abbott Vascular
Jan 29, 2020 NC TREK Coronary Dilatation Catheter, REF 1012455-120 Rx Only,NC TREK RX 5.00... Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon. Class I Abbott Vascular
Jan 29, 2020 NC TRAVELER Coronary Dilatation Catheter, REF 1013157-08, Rx Only,NC Traveler... Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon. Class I Abbott Vascular
Jan 29, 2020 NC TREK Coronary Dilatation Catheter, REF 1012454-20 Rx Only, NC TREK RX 4.50... Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon. Class I Abbott Vascular
Jan 29, 2020 Honeywell Pressure Transducer- Part Number: 370506-22. It is a component used... The firm is replacing pressure transducers with an improved design due to an increase in customer... Class II Fresenius Medical Care Holdings, Inc.
Jan 29, 2020 NC TREK Coronary Dilatation Catheter, REF 1012453-12 Rx Only, NC TREK RX 4.00... Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon. Class I Abbott Vascular
Jan 29, 2020 NC TREK Coronary Dilatation Catheter, REF 1012454-15 Rx Only, NC TREK RX 4.50... Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon. Class I Abbott Vascular

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.