Browse Device Recalls
3,528 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,528 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 3,528 FDA device recalls — Class I.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 | 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 | 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: 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 | 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: 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 |
| 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 | 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 |
| 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. |
| Feb 26, 2021 | Medtronic HVAD Battery, Product Number: 1650, 1650CA-CLIN, 1650DE | There is the potential for the Controller power cables (AC Adapter, DC Adapter, and Battery cable... | Class I | Heartware, Inc. |
| Feb 26, 2021 | Medtronic HVAD Alarm Adapter, Product Number: 1450 | There is the potential for the Controller power cables (AC Adapter, DC Adapter, and Battery cable... | Class I | Heartware, Inc. |
| Feb 26, 2021 | Instructions for Use and Patient Manual for HeartWare HVAD System. Accompanie... | Medtronic HeartWare HVAD System Instructions for Use (IFU) and Patient Manual (PM) updates regard... | Class I | Heartware, Inc. |
| Feb 26, 2021 | Medtronic HVAD Controller, Product Numbers: 1400, 1401, 1401AU, 1401BR, 1401... | There is the potential for the Controller power cables (AC Adapter, DC Adapter, and Battery cable... | Class I | Heartware, Inc. |
| Feb 26, 2021 | Alaris Pump Module, Model 8100, serviced/repaired by Step-Har Medical with an... | Bezel repair parts used, not by the original manufacturer, to service and repair infusion pump mo... | Class I | STEP-HAR MEDICAL LLC |
| Feb 26, 2021 | Medtronic HVAD Monitor Data Cable, Product Number: 1575 | There is the potential for the Controller power cables (AC Adapter, DC Adapter, and Battery cable... | Class I | Heartware, Inc. |
| Feb 26, 2021 | Medtronic HVAD Packaged Monitor, Model Numbers: 1500, 1500AU, 1500DE, 1510US... | There is the potential for the Controller power cables (AC Adapter, DC Adapter, and Battery cable... | Class I | Heartware, Inc. |
| Feb 26, 2021 | Power Supply: 1. Medtronic HVAD Controller AC Adapter, Product Numbers: 142... | There is the potential for the Controller power cables (AC Adapter, DC Adapter, and Battery cable... | Class I | Heartware, Inc. |
| Feb 25, 2021 | Alaris Infusion Pump Module, Model 8100, serviced/repaired by Biomedical Equi... | Bezel repair parts used, not by the original manufacturer, to service and repair infusion pump mo... | Class I | BioMedical Equipment Service Co (BMES) |
| Feb 25, 2021 | Alaris Infusion Pump 8100 Bezel (plastic piece only), Part: TIPA-8100-4410 | Bezel repair parts used, not by the original manufacturer, to service and repair infusion pump mo... | Class I | Tenacore LLC |
| Feb 25, 2021 | Alaris Infusion Pump Module, Model 8100, serviced/repaired by Tenacor with an... | Bezel repair parts used, not by the original manufacturer, to service and repair infusion pump mo... | Class I | Tenacore LLC |
| Feb 18, 2021 | ThermaCor 1200 Disposable Sets Components of the Smisson-Cartledge Biomedi... | Customers are being notified of results from a Toxicological Risk Assessment related to potential... | Class I | Smisson-Cartledge Biomedical, LLC |
| Feb 18, 2021 | ThermaCor 1200 Disposable Sets Components of the Smisson-Cartledge Biomedi... | Customers are being notified of results from a Toxicological Risk Assessment related to potential... | Class I | Smisson-Cartledge Biomedical, LLC |
| Feb 18, 2021 | ThermaCor 1200 Disposable Sets Components of the Smisson-Cartledge Biomedi... | Customers are being notified of results from a Toxicological Risk Assessment related to potential... | Class I | Smisson-Cartledge Biomedical, LLC |
| Feb 12, 2021 | Valiant Navion Thoracic Stent Graft System. For endovascular repair of lesio... | Due to the presence of type IIIb endoleaks, stent fractures, and stent ring enlargement. | Class I | Medtronic Vascular, Inc. |
| Feb 11, 2021 | PRECISE PRO RX CAROTID STENT implant system, Product Codes: PC0520RXC, PC053... | Distal tip may become separated from the lumen wire in specific lots. | Class I | Cordis Corporation |
| Feb 4, 2021 | Medtronic Affinity Pixie Hollow Fiber Oxygenator and Cardiotomy/Venous Reserv... | Products being recalled due to potentially elevated level of bacterial endotoxin. Patients expose... | Class I | Medtronic Perfusion Systems |
| Feb 4, 2021 | Custom Perfusion System (CUSTOM PACK BB10H89R4 ECLR). The Affinity Pixie Card... | Products being recalled due to potentially elevated level of bacterial endotoxin. Patients expose... | Class I | Medtronic Perfusion Systems |
| Feb 4, 2021 | Medtronic Custom Pack CP 1/4-1/4 Pediatric Set 1/B (PERFUSION M484901D 1/B). ... | Products being recalled due to potentially elevated level of bacterial endotoxin. Patients expose... | Class I | Medtronic Perfusion Systems |
| Feb 4, 2021 | Custom Perfusion System (CUSTOM PACK BB7W03R8 CCSM NEON). The Affinity Pixie ... | Products being recalled due to potentially elevated level of bacterial endotoxin. Patients expose... | Class I | Medtronic Perfusion Systems |
| Feb 4, 2021 | Custom Perfusion System (CUSTOM PACK HY10J00R6 ECC SMALL CAR). The Affinity ... | Products being recalled due to potentially elevated level of bacterial endotoxin. Patients expose... | Class I | Medtronic Perfusion Systems |
| Feb 4, 2021 | Medtronic Affinity Pixie BP241 Hollow Fiber Oxygenator and Cardiotomy/Venous ... | Products being recalled due to potentially elevated level of bacterial endotoxin. Patients expose... | Class I | Medtronic Perfusion Systems |
| Feb 4, 2021 | Medtronic Custom Pack CP Kinderset 1/4-1/4 MIT Pixie 1/B (PERFUSION M490817B ... | Products being recalled due to potentially elevated level of bacterial endotoxin. Patients expose... | Class I | Medtronic Perfusion Systems |
| Feb 4, 2021 | Medtronic Custom Pack Infant Tubingset Pixie Flow 0,8->1,5-1,8 1/B (PERFUSION... | Products being recalled due to potentially elevated level of bacterial endotoxin. Patients expose... | Class I | Medtronic Perfusion Systems |
| Feb 4, 2021 | Medtronic Custom Pack EVNP Clinical with AP40 1/B (PERFUSION M448036B 1/B). ... | Products being recalled due to potentially elevated level of bacterial endotoxin. Patients expose... | Class I | Medtronic Perfusion Systems |
| Feb 4, 2021 | Medtronic Custom Perfusion Pack (CUSTOM PACK HY11B40R1 1/4 RESPIRATO). The Af... | Products being recalled due to potentially elevated level of bacterial endotoxin. Patients expose... | Class I | Medtronic Perfusion Systems |
| Feb 3, 2021 | Implantable cardioverter defibrillators (ICD) with cardiac resynchronization ... | A small percentage of implanted cardiac devices, from a well-defined subset, may experience a sho... | Class I | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Feb 3, 2021 | Implantable cardioverter defibrillators (ICD): 1) Evera family: Evera XT DR,... | A small percentage of implanted cardiac devices, from a well-defined subset, may experience a sho... | Class I | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Jan 22, 2021 | ACIST Kodama Intravascular Ultrasound Catheter The Kodama Intravascular U... | Test results from the manufacturing line found a piece of damaged o-ring in an unexpected section... | Class I | Acist Medical Systems |
| Dec 23, 2020 | Fresh Whole Blood Donor Set (P/N 80-801-D NSN 6515016640306) . Blood conveni... | There is the potential of a bent or disconnected needle in one of the components of the convenien... | Class I | Combat Medical Systems, LLC |
| Dec 23, 2020 | Valkyrie LTOWB Collection (P/N 80-820, NSN 6515016862423). Blood collection ... | There is the potential of a bent or disconnected needle in one of the components of the convenien... | Class I | Combat Medical Systems, LLC |
| Dec 23, 2020 | Low Titer Type O FWB Transfusion Set (P/N 80-875 NSN 651501684994). Blood co... | There is the potential of a bent or disconnected needle in one of the components of the convenien... | Class I | Combat Medical Systems, LLC |
| Dec 23, 2020 | Valkyrie LTOWB Administration (P/N 80-821 NSN 6515016862401). Blood convenie... | There is the potential of a bent or disconnected needle in one of the components of the convenien... | Class I | Combat Medical Systems, LLC |
| Dec 23, 2020 | Fresh Whole Blood Transfusion Set (P/N 80-801 NSN 6515016574750) . Blood con... | There is the potential of a bent or disconnected needle in one of the components of the convenien... | Class I | Combat Medical Systems, LLC |
| Dec 18, 2020 | Liko Multirall 200 overhead lift- overhead lift is a general-purpose lift wi... | Multirall Q-link strap lock has not been fully engaged in the S65 rail carriage hook by user, lea... | Class I | Hill-Rom, Inc. |
| Dec 15, 2020 | Penumbra JET 7MAX KIT Penumbra JET 7 Reperfusion Catheter+ MAX Delivery Devic... | The catheter may become susceptible to distal tip damage during use. Distal tip damage in conjun... | Class I | Penumbra Inc. |
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.