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Vehicle Recalls320,000+ NHTSA safety recalls Browse VehiclesEvery make, model and year Complaints2.1M+ consumer safety complaints TSBs4.7M technical service bulletins VIN LookupDecode any vehicle VIN instantly OBD Codes12,000+ diagnostic trouble codes Fuel EconomyEPA MPG data for all vehicles Safety Ratings11,700+ NHTSA crash test ratings Investigations5,300+ NHTSA defect investigations StatisticsRecall trends & safety analysis Compare VehiclesTwo vehicles side by side

Consumer Safety

Product Safety9,700+ CPSC product recalls Food Safety28,600+ FDA food recalls Pet Safety1.3M FDA animal adverse events Drug Safety17,500+ FDA drug recalls Device Safety38,400+ FDA device recalls Workplace Safety102,900+ OSHA injury reports Brand HistoryRecall lookup by company

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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
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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 7 KIT Reperfusion Catheter+Penumbra Hi-Flow Aspiration Tubing RE... The catheter may become susceptible to distal tip damage during use. Distal tip damage in conjun... Class I Penumbra Inc.
Dec 15, 2020 Penumbra JET 7 Reperfusion Catheter REF 5MAXJET7 The Penumbra JET 7 Reperf... The catheter may become susceptible to distal tip damage during use. Distal tip damage in conjun... Class I Penumbra 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.
Dec 15, 2020 Penumbra JET 7 KIT Reperfusion Catheter+Penumbra Hi-Flow Aspiration Tubing RE... The catheter may become susceptible to distal tip damage during use. Distal tip damage in conjun... Class I Penumbra Inc.
Dec 2, 2020 EMBLEM S-ICD Model A209 Electrical overstress may lead to device malfunction. Class I Boston Scientific Corporation
Dec 2, 2020 EMBLEM MRI S-ICD Model A219 Electrical overstress may lead to device malfunction. Class I Boston Scientific Corporation
Nov 24, 2020 Flexor Check-Flo Introducer, RPN KCFW-6.0-35-55-RB-HFANL0-HC, Order Number G5... There is an increased likelihood of the introducer sheath separating at the proximal bond site. ... Class I Cook Inc.
Nov 24, 2020 Flexor Check-Flo Introducer, RPN KCFW-8.0-35-55-RB-HFANL0-HC, Order Number G5... There is an increased likelihood of the introducer sheath separating at the proximal bond site. ... Class I Cook Inc.
Nov 24, 2020 Flexor Check-Flo Introducer, RPN KCFW-6.0-35-55-RB-HFANL1-HC, Order Number G5... There is an increased likelihood of the introducer sheath separating at the proximal bond site. ... Class I Cook Inc.
Nov 24, 2020 Flexor Check-Flo Introducer, RPN KCFW-5.0-35-70-RB-HFANL0-HC, Order Number G5... There is an increased likelihood of the introducer sheath separating at the proximal bond site. ... Class I Cook Inc.
Nov 24, 2020 Flexor Check-Flo Introducer, RPN KCFW-8.0-35-70-RB-HFANL0-HC, Order Number G5... There is an increased likelihood of the introducer sheath separating at the proximal bond site. ... Class I Cook Inc.
Nov 24, 2020 Flexor Check-Flo Introducer, RPN KCFW-4.0-35-55-RB-HFANL0-HC, Order Number G5... There is an increased likelihood of the introducer sheath separating at the proximal bond site. ... Class I Cook Inc.
Nov 24, 2020 Flexor Tuohy-Borst Side-Arm Introducer (Shuttle Select), RPN KSAW-5.0-38-90-R... There is an increased likelihood of the introducer sheath separating at the proximal bond site. ... Class I Cook Inc.
Nov 24, 2020 Flexor Check-Flo Introducer, RPN KCFW-8.0-35-55-RB-HFANL1-HC, Order Number G4... There is an increased likelihood of the introducer sheath separating at the proximal bond site. ... Class I Cook Inc.
Nov 24, 2020 Flexor Check-Flo Introducer, RPN KCFW-7.0-35-70-RB-HFANL1-HC, Order Number G5... There is an increased likelihood of the introducer sheath separating at the proximal bond site. ... Class I Cook 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.