Browse Device Recalls

1,624 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 1,624 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 1,624 FDA device recalls in MN.

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Date	Product	Reason	Class	Firm
Feb 13, 2025	smiths medical ProPort Low Profile Plastic Venous Access System, Silicone Cat...	The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate...	Class I	Smiths Medical ASD, Inc.
Feb 13, 2025	smiths medical ProPort Plastic Venous Access System, Silicone Catheter, 2.87,...	The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate...	Class I	Smiths Medical ASD, Inc.
Feb 13, 2025	smiths medical ProPort Plastic Venous Access System, Silicone Catheter, 2.8mm...	The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate...	Class I	Smiths Medical ASD, Inc.
Feb 13, 2025	Portex Endotracheal Tube, Item Codes 100/105/025 100/105/030 100/105/035 100/...	Affected devices have a smaller diameter than expected and may potentially result in inadequate v...	Class I	Smiths Medical ASD, Inc.
Feb 13, 2025	smiths medical ProPort Plastic Venous Access System, Pre-assembled with PolyF...	The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate...	Class I	Smiths Medical ASD, Inc.
Feb 13, 2025	smiths medical ProPort Plastic Venous Access System, Pre-assembled with PolyF...	The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate...	Class I	Smiths Medical ASD, Inc.
Feb 13, 2025	smiths medical ProPort Plastic Venous Access System, Pre-assembled with PolyF...	The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate...	Class I	Smiths Medical ASD, Inc.
Feb 13, 2025	smiths medical ProPort Low Profile Plastic Venous Access System, PolyFlow Pol...	The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate...	Class I	Smiths Medical ASD, Inc.
Feb 13, 2025	smiths medical ProPort Plastic Venous Access System, Implantable Venous Acces...	The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate...	Class I	Smiths Medical ASD, Inc.
Feb 6, 2025	DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, with Component P...	Beckman Coulter identified that an issue for DxI 9000 tip stocker interface (TSI) and reagent sto...	Class II	Beckman Coulter, Inc.
Feb 5, 2025	DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137.	the DxI 9000 encoder wheel was misaligned on the motor shaft, leading to increased slippage error...	Class II	Beckman Coulter, Inc.
Feb 5, 2025	Access 2 Immunoassay Analyzer, Catalog Number 81600N	Beckman Coulter identified that an issue for Access 2 Sample Motors (B48016) due to improper alig...	Class II	Beckman Coulter, Inc.
Feb 5, 2025	Aortic Root Cannula: 1. DLP Aortic Root Cannula A. CANNULA 11012 AR FLOWGUA...	Unexpected loose material in the male luer used in the aortic root cannula has been identified. P...	Class I	Medtronic Perfusion Systems
Feb 3, 2025	Access Erythropoietin (EPO), Catalog Number - A16364 a glycoprotein (~30,400...	Affected lot (439363) exhibited a negative dose drop of -22% with native patient samples compared...	Class II	Beckman Coulter, Inc.
Jan 20, 2025	Microbiologics Multi-Strain Human Papillomavirus (HPV) Verification Panel (In...	Internal quality control procedures were not followed correctly for the testing/release of three ...	Class II	Microbiologics Inc
Jan 20, 2025	Microbiologics Multi-Strain Human Papillomavirus (HPV) Control Panel (Inactiv...	Internal quality control procedures were not followed correctly for the testing/release of three ...	Class II	Microbiologics Inc
Jan 9, 2025	A820 myPTM Software Application associated with Medtronic SynchroMed Pump and...	Product complaints were received describing the A820 myPTM app taking longer than expected for pa...	Class II	Medtronic Neuromodulation
Dec 16, 2024	Hot Dog PATIENT WARMING, Underbody Warming Mattress + Return Electrode, 89 cm...	There is over-molding that stabilizes the connection between the cable and cable-entry on the mat...	Class II	Augustine Temperature Management, LLC
Dec 16, 2024	Hot Dog PATIENT WARMING, Underbody Warming Mattress + Return Electrode, 82 cm...	There is over-molding that stabilizes the connection between the cable and cable-entry on the mat...	Class II	Augustine Temperature Management, LLC
Dec 16, 2024	Hot Dog PATIENT WARMING, Underbody Warming Mattress + Return Electrode, 127 c...	There is over-molding that stabilizes the connection between the cable and cable-entry on the mat...	Class II	Augustine Temperature Management, LLC
Dec 12, 2024	Select Series Angled Tip Arterial Cannula, Model Number 72422 (22 Fr)	Incorrect labeling for seven manufactured lots of certain models of Arterial Cannulae.	Class II	Medtronic Perfusion Systems
Dec 12, 2024	ALTRUA 2 DR Pacemaker, SL (Model Number S702) and EL (Model Number S722)	A subset of devices from the ACCOLADE Family of Pacemakers and CRT-Ps, built before September 201...	Class I	Boston Scientific Corporation
Dec 12, 2024	VISIONIST CRT-P, EL (Model Number U225 and U226) and EL MRI (Model Number U228)	A subset of devices from the ACCOLADE Family of Pacemakers and CRT-Ps, built before September 201...	Class I	Boston Scientific Corporation
Dec 12, 2024	EOPA Arterial Cannula, Model Numbers 77422 (22 Fr) and 77418 (18 Fr)	Incorrect labeling for seven manufactured lots of certain models of Arterial Cannulae.	Class II	Medtronic Perfusion Systems
Dec 12, 2024	ESSENTIO DR Pacemaker, SL (Model Number L101, SL MRI (Model Number L111), EL ...	A subset of devices from the ACCOLADE Family of Pacemakers and CRT-Ps, built before September 201...	Class I	Boston Scientific Corporation
Dec 12, 2024	ACCOLADE DR Pacemaker, SL (Model Number L301), SL MRI (Model Number L311), EL...	A subset of devices from the ACCOLADE Family of Pacemakers and CRT-Ps, built before September 201...	Class I	Boston Scientific Corporation
Dec 12, 2024	PROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209),...	A subset of devices from the ACCOLADE Family of Pacemakers and CRT-Ps, built before September 201...	Class I	Boston Scientific Corporation
Dec 12, 2024	VALITUDE CRT-P, EL (Model Number U125) and EL MRI (Model Number U128)	A subset of devices from the ACCOLADE Family of Pacemakers and CRT-Ps, built before September 201...	Class I	Boston Scientific Corporation
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

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.