Browse Device Recalls

1,646 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 1,646 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 1,646 FDA device recalls in MN.

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DateProductReasonClassFirm
Dec 12, 2024 DLP Pediatric One-Piece Arterial Cannulae, Model Numbers 77008 (8 Fr) and 770... Incorrect labeling for seven manufactured lots of certain models of Arterial Cannulae. Class II Medtronic Perfusion Systems
Dec 11, 2024 nuwellis AquaFlexFlow UF 500 Plus, REF 114156, Catalog Number A06163, extraco... The AquaFlexFlow UF 500 Plus extracorporeal blood circuit used with the Aquadex SmartFlow and Fle... Class I Nuwellis Inc
Dec 10, 2024 Medtronic NanoCross Elite PTA catheter, REF numbers amd sizes: 1) AB14W0... There is the potential for in-vivo balloon deflation issues, including difficulty or inability to... Class II ev3 Inc
Dec 4, 2024 Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Contr... Instructions for use update on HotDog Temperature Management Controllers Models WC71, WC77, and T... Class II Augustine Temperature Management, LLC
Dec 4, 2024 Hillrom Temperature Management Controller, MP, Model # 2083516; used in conju... Instructions for use update on HotDog Temperature Management Controllers Models WC71, WC77, and T... Class II Augustine Temperature Management, LLC
Dec 4, 2024 Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Contr... Instructions for use update on HotDog Temperature Management Controllers Models WC71, WC77, and T... Class II Augustine Temperature Management, LLC
Dec 2, 2024 Folysil Silicone Foley Catheters, Device Reference Numbers AA6106, AA6108, AA... A possible sterility issue was detected in Coloplast's facility on some Coloplast products. Class II Coloplast Manufacturing US, LLC
Dec 2, 2024 X-Flow prostatectomy catheter, Device Reference Numbers AB6022, AB6024, AB611... A possible sterility issue was detected in Coloplast's facility on some Coloplast products. Class II Coloplast Manufacturing US, LLC
Nov 26, 2024 Access Intact PTH assay, a paramagnetic particle, chemiluminescent immunoassa... Beckman Coulter has identified that some Access PTH reagent packs from lot 339071 may be over- or... Class II Beckman Coulter, Inc.
Nov 22, 2024 Clarity Precision Grip Attachments, for use in orthodontic treatment. Part... Attachments may not mate with the tooth as intended in the digital treatment design. Class II 3M Company - Health Care Business
Nov 21, 2024 SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used... Software issues were identified in application version 2.x. Class II Medtronic Neuromodulation
Nov 21, 2024 SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used... Software issues were identified in application version 2.x. Class II Medtronic Neuromodulation
Nov 21, 2024 SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used... Software issues were identified in application version 2.x. Class II Medtronic Neuromodulation
Nov 21, 2024 SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used... Software issues were identified in application version 2.x. Class II Medtronic Neuromodulation
Nov 18, 2024 EnVisio Patient Pad Transition Cushion, Model/Catalog Number: ENVISIO-SYS Pr... There is a potential safety risk caused by physical disassociation of the back section from the b... Class II Elucent Medical Inc
Nov 18, 2024 Access hsTnI Reagent, REF B52699, Immunoassay Method, Troponin Subunit. For ... Beckman Coulter, Inc. is recalling their Access hsTnI assay, a medical device by correction. The ... Class II Beckman Coulter, Inc.
Nov 13, 2024 DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137 The DxI 9000 Access Immunoassay Analyzer wash wheel mixer may not spin freely within the idler p... Class II Beckman Coulter, Inc.
Nov 7, 2024 DiaSorin LIAISON Q.S.E.T. Device Plus, REF 319060; intended for use in the pr... Customer complaints were received alleging leaking devices and insufficient buffer volume. Diasor... Class II Diasorin Inc.
Oct 28, 2024 smiths medical portex Venn Reusable Tracheal Tube Introducer, 15Ch x 60cm, R... Smiths Medical has identified a potential for ingress of fluid into the device during reprocessin... Class II Smiths Medical ASD, Inc.
Oct 28, 2024 smiths medical PORTEX Tracheal Tube Exchange Guide, 10Ch x 70cm, REF 14-504-76 Smiths Medical has identified a potential for ingress of fluid into the device during reprocessin... Class II Smiths Medical ASD, Inc.
Oct 28, 2024 smiths medical PORTEX Tracheal Tube Exchange Guide, 15Ch x 70cm, REF 14-504-... Smiths Medical has identified a potential for ingress of fluid into the device during reprocessin... Class II Smiths Medical ASD, Inc.
Oct 17, 2024 Abbot Navitor, Vision Technology, Transcatheter Aortic Heart Valve, 29 mm, NV... A manufacturing error resulting in acceptance of valves with a leaflet deflection value that was ... Class II Abbott Medical
Oct 17, 2024 Abbott Navitor, Vision Technology, Transcatheter Aortic Heart Valve, 27 mm, N... A manufacturing error resulting in acceptance of valves with a leaflet deflection value that was ... Class II Abbott Medical
Oct 17, 2024 Abbott Navitor Titan, Vision Technology, Transcatheter Aortic Heart Valve, 3... A manufacturing error resulting in acceptance of valves with a leaflet deflection value that was ... Class II Abbott Medical
Oct 17, 2024 Abbott Navitor Transcatheter Aortic Heart Valve, 29 mm, NVTR-29, Sterile A manufacturing error resulting in acceptance of valves with a leaflet deflection value that was ... Class II Abbott Medical
Oct 17, 2024 Abbott Navitor Transcatheter Aortic Heart Valve, 27 mm, NVTR-27, Sterile A manufacturing error resulting in acceptance of valves with a leaflet deflection value that was ... Class II Abbott Medical
Oct 10, 2024 Boston Scientific POLARx BALLOON CATHETER ST 28MM OUS, Material Number M004CR... Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablatio... Class I Boston Scientific Corporation
Oct 10, 2024 Boston Scientific POLARx FIT BALLOON CATHETER ST OUS, Material Number M004CR... Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablatio... Class I Boston Scientific Corporation
Oct 10, 2024 Boston Scientific SMARTFREEZE CRYO CONSOLE: Console: Material Number M004... Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablatio... Class I Boston Scientific Corporation
Oct 10, 2024 Boston Scientific POLARx FIT BALLOON CATHETER LT OUS, Material Number M004CRB... Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablatio... Class I Boston Scientific Corporation
Oct 10, 2024 Boston Scientific POLARx FIT BALLOON CATHETER LT US, Material Number M004CRBS... Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablatio... Class I Boston Scientific Corporation
Oct 10, 2024 Boston Scientific POLARx FIT BALLOON CATHETER ST US, Material Number M004CRBS... Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablatio... Class I Boston Scientific Corporation
Oct 10, 2024 Boston Scientific POLARx BALLOON CATHETER LT 28MM OUS, Material Number M004CR... Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablatio... Class I Boston Scientific Corporation
Oct 3, 2024 Medtronic DLP Aortic Root Cannula with Flow-Guard, REF 11012; for use in card... There is the potential for a potential sterility breach for three lots of the DLP Aortic Root Can... Class II Medtronic Perfusion Systems
Sep 30, 2024 The Access Cortisol assay is a paramagnetic particle, chemiluminescent immun... The Access Cortisol assay protocol file (APF) applies an incorrect calibration curve acceptance p... Class II Beckman Coulter, Inc.
Sep 24, 2024 medex TranStar KIDS KIT 31IN. CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Devi... Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interrupti... Class II Smiths Medical ASD, Inc.
Sep 24, 2024 medex TranStar Disposable Transducer 1/EA, Product Code REF MX950 Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interrupti... Class II Smiths Medical ASD, Inc.
Sep 24, 2024 medex TranStar KIDS KIT 19IN. CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Devi... Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interrupti... Class II Smiths Medical ASD, Inc.
Sep 24, 2024 medex NICU Monitoring Kit Set 1/EA, Product Code REF MX20086 Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interrupti... Class II Smiths Medical ASD, Inc.
Sep 24, 2024 medex TranStar Kit w/ Stopcock1/EA, Product Code REF MX20740 Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interrupti... Class II Smiths Medical ASD, Inc.
Sep 24, 2024 medex TranStar Neonatal Monitoring Kit 10/EA, Product Code REF MX9530T Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interrupti... Class II Smiths Medical ASD, Inc.
Sep 24, 2024 medex TranStar 72in (183cm) Double Monitoring Kit 10/EA, Product Code REF MX9... Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interrupti... Class II Smiths Medical ASD, Inc.
Sep 24, 2024 medex TranStar Single OR Set 1/EA, Product Code REF MX20846R2 Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interrupti... Class II Smiths Medical ASD, Inc.
Sep 24, 2024 medex TranStar Single ICP Set 1/EA, Product Code REF MX20897 Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interrupti... Class II Smiths Medical ASD, Inc.
Sep 24, 2024 medex TranStar SINGLE 84IN SET WITH ANTI-SHUNT STOPCOCK 10/EA, Product Code R... Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interrupti... Class II Smiths Medical ASD, Inc.
Sep 24, 2024 medex TranStar 60in (152cm) Single Monitoring Kit 10/EA, Product Code REF MX9... Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interrupti... Class II Smiths Medical ASD, Inc.
Sep 24, 2024 medex TranStar 84in (213cm) Single Monitoring Kit 10/EA, Product Code REF MX9... Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interrupti... Class II Smiths Medical ASD, Inc.
Sep 24, 2024 Medtronic Percept RC Implantable Neurostimulators (INS), Model B35300. A limited number of Percept RC Implantable Neurostimulators (INS), Model B35300 will not be able ... Class II Medtronic Neuromodulation
Sep 24, 2024 medex TranStar DPT w/Two Stopcocks 10/EA, Product Code REF MX950X2SC Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interrupti... Class II Smiths Medical ASD, Inc.
Sep 24, 2024 medex TranStar KIDS KIT 10IN. CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Devi... Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interrupti... Class II Smiths Medical ASD, 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.