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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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.