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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jun 3, 2021 | HeartWare HVAD Pump Implant Kit, REF 1125 | Medtronic is stopping the distribution and sale of the HVAD System due to a growing body of obser... | Class I | Heartware, Inc. |
| Jun 3, 2021 | HeartWare HVAD Pump Implant Kit, REF 1153 | Medtronic is stopping the distribution and sale of the HVAD System due to a growing body of obser... | Class I | Heartware, Inc. |
| Jun 3, 2021 | HeartWare HVAD Outflow Graft, REF MCS1725OG | Medtronic is stopping the distribution and sale of the HVAD System due to a growing body of obser... | Class I | Heartware, Inc. |
| Jun 3, 2021 | HeartWare HVAD Pump Accessories, REF MCS1753AK | Medtronic is stopping the distribution and sale of the HVAD System due to a growing body of obser... | Class I | Heartware, Inc. |
| Jun 3, 2021 | INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021) | The dual chamber INGENIO family pacemakers or cardiac resynchronization therapy pacemakers (CRT-P... | Class I | Boston Scientific Corporation |
| Jun 3, 2021 | HeartWare HVAD Driveline Extension Cable, REF 100 | Medtronic is stopping the distribution and sale of the HVAD System due to a growing body of obser... | Class I | Heartware, Inc. |
| Jun 3, 2021 | HeartWare HVAD Pump Implant Kit, REF 1103 | Medtronic is stopping the distribution and sale of the HVAD System due to a growing body of obser... | Class I | Heartware, Inc. |
| Jun 3, 2021 | HeartWare HVAD Pump Implant Kit, REF 1104 | Medtronic is stopping the distribution and sale of the HVAD System due to a growing body of obser... | Class I | Heartware, Inc. |
| Jun 3, 2021 | HeartWare HVAD Implant Kit, REF 1104JP | Medtronic is stopping the distribution and sale of the HVAD System due to a growing body of obser... | Class I | Heartware, Inc. |
| Jun 3, 2021 | INTUA CRT-P, Model Numbers: a) V272 b) V273 c) W273 | The dual chamber INGENIO family pacemakers or cardiac resynchronization therapy pacemakers (CRT-P... | Class I | Boston Scientific Corporation |
| Jun 3, 2021 | INGENIO DR EL (pacemakers), Model Numbers: a) J174 b) J177 c) K174 (added 7/... | The dual chamber INGENIO family pacemakers or cardiac resynchronization therapy pacemakers (CRT-P... | Class I | Boston Scientific Corporation |
| Jun 3, 2021 | HeartWare HVAD Driveline Extension Cable, REF 100US | Medtronic is stopping the distribution and sale of the HVAD System due to a growing body of obser... | Class I | Heartware, Inc. |
| Jun 3, 2021 | ADVANTIO DR EL (pacemaker), Model Numbers: a) J064 b) J067 c) K064 (added 7/... | The dual chamber INGENIO family pacemakers or cardiac resynchronization therapy pacemakers (CRT-P... | Class I | Boston Scientific Corporation |
| Jun 3, 2021 | INVIVE CRT-P, Model Numbers: a) V172 b) V173 c) V182 d) V183 e) W172 f... | The dual chamber INGENIO family pacemakers or cardiac resynchronization therapy pacemakers (CRT-P... | Class I | Boston Scientific Corporation |
| Jun 3, 2021 | HeartWare HVAD Implant Kit, REF MCS1705PU | Medtronic is stopping the distribution and sale of the HVAD System due to a growing body of obser... | Class I | Heartware, Inc. |
| Jun 3, 2021 | VITALIO DR EL (pacemaker), Model Numbers: a) J274 b) J277 c) K274 (added 7/1... | The dual chamber INGENIO family pacemakers or cardiac resynchronization therapy pacemakers (CRT-P... | Class I | Boston Scientific Corporation |
| May 19, 2021 | GENOSYL DS; Nitric Oxide Delivery System Combination Product NDA202860 | Reports received of NO measured below desired dose during transition between primary console and ... | Class I | Vero Biotech, LLC |
| May 17, 2021 | JELCO HYPODERMIC NEEDLE-PRO FIXED NEEDLE INSULIN SYRINGE: a) 1.0mL 28G X 1/2... | Specific models and lot numbers of the Jelco Hypodermic Needle-Pro Fixed Needle Insulin Syringe 2... | Class I | Smiths Medical ASD Inc. |
| May 14, 2021 | DeRoyal Angio Cath Removal Tray, REF 89-9936.02 | DeRoyal manufactured certain lots of surgical procedure pack products using Hospira Pfizer 1% Lid... | Class I | DeRoyal Industries Inc |
| May 14, 2021 | DeRoyal Heart Cath Procedure Pack, REF 89-6556.08 | DeRoyal manufactured certain lots of surgical procedure pack products using Hospira Pfizer 1% Lid... | Class I | DeRoyal Industries Inc |
| May 14, 2021 | DeRoyal Pacemaker Tray Pgybk, REF 89-6360.06 | DeRoyal manufactured certain lots of surgical procedure pack products using Hospira Pfizer 1% Lid... | Class I | DeRoyal Industries Inc |
| May 7, 2021 | LeadCare Ultra Blood Lead Test Kit Catalog Number 70-8098 | Magellan has received reports that control tests of either the Low-Control and/or the High-Contro... | Class I | Magellan Diagnostics, Inc. |
| May 7, 2021 | LeadCare Plus Blood Lead Test Kit Catalog Number 82-0004 | Magellan has received reports that control tests of either the Low-Control and/or the High-Contro... | Class I | Magellan Diagnostics, Inc. |
| May 7, 2021 | LeadCare II Blood Lead Test Kit Catalog Number 70-6762 | Magellan has received reports that control tests of either the Low-Control and/or the High-Contro... | Class I | Magellan Diagnostics, Inc. |
| May 4, 2021 | Angiographic Guidewire Component: Model Number: 107042, 107044, 107447, 11000... | The component part numbers intended for shipment to a third-party, where they are further process... | Class I | Medtronic Vascular |
| Apr 27, 2021 | Lyra SARS-CoV-2 Assay (M120) in vitro diagnostic test reagent | In rare situations patients infected with high viral load of SARS CoV 2 may have samples that gen... | Class I | Quidel Corporation |
| Apr 26, 2021 | Leccurate SARS-CoV-2, Antibody Rapid Test Kit (Colloidal Gold Immunochromatog... | Leccurate SARS-CoV-2, Antibody Rapid Test Kit (Colloidal Gold Immunochromatography) is not author... | Class I | LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD |
| Apr 26, 2021 | Leccurate SARS-CoV-2, Antigen Rapid Test Kit (Colloidal Gold Immunochromatogr... | Antigen Rapid Test Kit is not authorized, cleared, or approved for marketing and/or distribution ... | Class I | LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD |
| Apr 12, 2021 | VICI VENOUS STENT System Product Usage: is intended for the treatment of o... | The firm has received reports of stent migration after implantation | Class I | Boston Scientific Corporation |
| Apr 12, 2021 | VICI RDS VENOUS STENT System Product Usage: is indicated for improving lum... | The firm has received reports of stent migration after implantation | Class I | Boston Scientific Corporation |
| Apr 9, 2021 | FISTULA ON-OFF KIT. Medical convenience kit, Avid Medical Part Number: MMTN020. | Medical convenience kits are being recalled due to a potential breach in the package integrity of... | Class I | Avid Medical, Inc. |
| Apr 9, 2021 | DIALYSIS ACCESS Medical convenience kit, Avid Medical Part Number: VMED004-03. | Medical convenience kits are being recalled due to a potential breach in the package integrity of... | Class I | Avid Medical, Inc. |
| Apr 9, 2021 | COVID-19 Self-Test Kit *** INNOVA *** 3T | Due to distributing test kits to customers who were not part of a clinical investigation. | Class I | INNOVA MEDICAL GROUP, INC. |
| Apr 9, 2021 | Kit: LVAD Dres Chg. MAI Kit Part Number: 79544B | Medical convenience kits are being recalled due to a potential breach in the package integrity o... | Class I | Medical Action Industries, Inc. 306 |
| Apr 9, 2021 | Kit: CentralLineDresChangeClrSeq MAI Kit Part Number: 79420 | Medical convenience kits are being recalled due to a potential breach in the package integrity o... | Class I | Medical Action Industries, Inc. 306 |
| Apr 9, 2021 | For In Vitro Diagnostic Use Only *** 25T 888 SARS-CoV-2 Antigen *** SARS-CoV-... | Due to distributing test kits to customers who were not part of a clinical investigation. | Class I | INNOVA MEDICAL GROUP, INC. |
| Apr 9, 2021 | ADULT CHEST TUBE TRAY. Medical convenience kit, Avid Medical Part Number: LAK... | Medical convenience kits are being recalled due to a potential breach in the package integrity of... | Class I | Avid Medical, Inc. |
| Apr 9, 2021 | Kit: Blood Culture. MAI Kit Part Number: 80315D | Medical convenience kits are being recalled due to a potential breach in the package integrity o... | Class I | Medical Action Industries, Inc. 306 |
| Apr 9, 2021 | FISTULA (ON/OFF) ALL IN ONE BAG. Medical convenience kit, Avid Medical Part ... | Medical convenience kits are being recalled due to a potential breach in the package integrity of... | Class I | Avid Medical, Inc. |
| Apr 9, 2021 | Kit: Midline Insertion DA. MAI Kit Part Number: 77981B | Medical convenience kits are being recalled due to a potential breach in the package integrity o... | Class I | Medical Action Industries, Inc. 306 |
| Apr 9, 2021 | COVID-19 Self-Test Kit *** INNOVA *** 7T | Due to distributing test kits to customers who were not part of a clinical investigation. | Class I | INNOVA MEDICAL GROUP, INC. |
| Apr 9, 2021 | Kit: Injection REVIEW MAI Kit Part Number: 74736 | Medical convenience kits are being recalled due to a potential breach in the package integrity o... | Class I | Medical Action Industries, Inc. 306 |
| Apr 9, 2021 | Kit: Blood Culture MAI Kit Part Number: 80076 | Medical convenience kits are being recalled due to a potential breach in the package integrity o... | Class I | Medical Action Industries, Inc. 306 |
| Mar 26, 2021 | Alaris Pump Module, Model 8100, serviced/repaired by Infusion Pump Repair wit... | Bezel repair parts used, not by the original manufacturer, to service and repair infusion pump mo... | Class I | Infusion Pump Repair |
| Mar 25, 2021 | Alaris Infusion Pump Module, Model 8100, serviced/repaired by The Biomed Guys... | Bezel repair part, not by the original manufacturer, used in the service and repair of Alaris Pum... | Class I | The Biomed Guys |
| Mar 24, 2021 | Aftermarket Alaris Infusion Pump Module Model 8100 Front Bezel, installed by ... | Aftermarket front bezel components were installed during service/repair, not by the original manu... | Class I | Pacific Medical Group Inc. |
| Mar 15, 2021 | ENDURITY Pulse Generator REF PM**** SN ********* St. Jude Medical Cardiac Rh... | Due to a manufacturing issue associated with the mixing process of the epoxy used in the manufact... | Class I | St. Jude Medical, Cardian Rhythm Management Div... |
| Mar 15, 2021 | ASSURITY Pulse Generator REF PM**** SN ********* ST. JUDE MEDICAL Assur... | Due to a manufacturing issue associated with the mixing process of the epoxy used in the manufact... | Class I | St. Jude Medical, Cardian Rhythm Management Div... |
| Mar 3, 2021 | BD Alaris Infusion Pump Module Model 8100 Pump Module Keypad; and Pump Module... | Pump Module keypad lifting, and Fluid ingress could result in 1) Unresponsive keys: module contin... | Class I | CareFusion 303, Inc. |
| Mar 3, 2021 | Medtronic Bio-Console 560 Extracorporeal Blood Pumping Console, Model Numbers... | An electrical component within the system controller module of certain Bio-Console 560 devices ma... | Class I | Medtronic Perfusion Systems |
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.