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
Jun 1, 2021	Medtronic Reveal LINQ LNQ11 / PA96000	Reveal LINQ with TruRhythm ICMs, that undergo a partial electrical reset appear to be programmed ...	Class II	Medtronic Inc., Cardiac Rhythm and Heart Failur...
May 28, 2021	Aequalis Ascend Flex Shoulder System Reversed Platform (Reversed Tray compone...	Two lots have been swapped thus have the incorrect product in the package. The component may be o...	Class II	Tornier, Inc
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	PORTEX UNLTRperc Percutaneous Dilation Tracheostomy Kit, REF 100/596/090 - Pr...	One lot number of a specific model of ULTRAperc Percutaneous Dilation Tracheostomy Kit, 9.0mm may...	Class II	Smiths Medical ASD Inc.
May 14, 2021	Medtronic LINQ II Model Number # LNQ22 Insertable Cardiac Monitor Sterile EO ...	Device fail to detect Brady episodes, Pause (Asystole) episodes and PVC's after a ride-through PO...	Class II	Medtronic Inc., Cardiac Rhythm and Heart Failur...
May 5, 2021	v.1.2 Upgrade Kit or v.1.2 upgrade installed on WorkMate Claris System, Model...	Due to a software error, the user may lose functionality of the system or the screen may turn bla...	Class II	Abbott Laboratories Inc. (St Jude Medical)
May 5, 2021	WorkMate Claris v.1.2 Upgrade Kits, Model Numbers H800007 and H800012	Due to a software error, the user may lose functionality of the system or the screen may turn bla...	Class II	Abbott Laboratories Inc. (St Jude Medical)
May 5, 2021	v.1.2 Upgrade Kit or v.1.2 upgrade installed on WorkMate Claris" System Displ...	Due to a software error, the user may lose functionality of the system or the screen may turn bla...	Class II	Abbott Laboratories Inc. (St Jude Medical)
Apr 29, 2021	Medtronic HY8R62R13,Custom Pack HY8R62R13 E Pack, Custom Perfusion System, St...	Specific lots may have been manufactured with insufficient or incomplete welds.	Class II	Medtronic Perfusion Systems
Apr 29, 2021	Medtronic HY8M63R4, Custom Pack HY8M63R4 Adult ECC, Custom Perfusion System, ...	Specific lots may have been manufactured with insufficient or incomplete welds.	Class II	Medtronic Perfusion Systems
Apr 29, 2021	Medtronic CB1H18R20, Custom Pack CB1H18R20 Accesory, Custom Perfusion System,...	Specific lots may have been manufactured with insufficient or incomplete welds.	Class II	Medtronic Perfusion Systems
Apr 29, 2021	Medtronic HY7M07R6, Custom Pack HY7M07R6 E 1/4, Custom Perfusion System, Ster...	Specific lots may have been manufactured with insufficient or incomplete welds.	Class II	Medtronic Perfusion Systems
Apr 29, 2021	Medtronic 1A46R11, Custom Pack 1A46R11 Neonatal, Custom Perfusion System, Ste...	Specific lots may have been manufactured with insufficient or incomplete welds.	Class II	Medtronic Perfusion Systems
Apr 29, 2021	Medtronic CB10R55R5, Custom Pack CB10R55R5 3/8X3/8 Loop, Custom Perfusion Sys...	Specific lots may have been manufactured with insufficient or incomplete welds.	Class II	Medtronic Perfusion Systems
Apr 29, 2021	Medtronic HY10Y54R4, Custom Pack HY10Y54R4 ECC PED 1/4, Custom Perfusion Syst...	Specific lots may have been manufactured with insufficient or incomplete welds.	Class II	Medtronic Perfusion Systems
Apr 29, 2021	Medtronic HY11B40R1, Custom Pack HY11B40R1 1/4 Respirato, Custom Perfusion Sy...	Specific lots may have been manufactured with insufficient or incomplete welds.	Class II	Medtronic Perfusion Systems
Apr 29, 2021	Medtronic HY10J00R12, Custom Pack HY10J00R12 ECC Small CA, Custom Perfusion S...	Specific lots may have been manufactured with insufficient or incomplete welds.	Class II	Medtronic Perfusion Systems
Apr 29, 2021	Medtronic BB7D76R13, Custom Pack BB7D76R13 CORR HL, Custom Perfusion System, ...	Specific lots may have been manufactured with insufficient or incomplete welds.	Class II	Medtronic Perfusion Systems
Apr 29, 2021	Medtronic HY10D90R2, Custom Pack HY10D90R2 3/8 ACC, Custom Perfusion System, ...	Specific lots may have been manufactured with insufficient or incomplete welds.	Class II	Medtronic Perfusion Systems
Apr 29, 2021	Medtronic CB10W65R1, Custom Pack CB10W65R1 CH Access1/4, Custom Perfusion Sys...	Specific lots may have been manufactured with insufficient or incomplete welds.	Class II	Medtronic Perfusion Systems
Apr 29, 2021	Medtronic BB9G78R8, Custom Pack BB9G78R8 ECC Supp, Custom Perfusion System, S...	Specific lots may have been manufactured with insufficient or incomplete welds.	Class II	Medtronic Perfusion Systems
Apr 29, 2021	Medtronic BB11J14R2, Custom Pack BB11J14R2 Bridge, Custom Perfusion System, S...	Specific lots may have been manufactured with insufficient or incomplete welds.	Class II	Medtronic Perfusion Systems
Apr 29, 2021	Medtronic CB7J97R8, Custom Pack CB7J97R8 U14 E Sup, Custom Perfusion System, ...	Specific lots may have been manufactured with insufficient or incomplete welds.	Class II	Medtronic Perfusion Systems
Apr 29, 2021	Medtronic HY10Z48R2, Ctr., Custom Pack HY10Z48R2 Adult ECC 1/4, Custom Perfu...	Specific lots may have been manufactured with insufficient or incomplete welds.	Class II	Medtronic Perfusion Systems
Apr 29, 2021	Medtronic CB10R79R6, Custom Pack CB10R79R6 1/4X1/4 Loop, Custom Perfusion Sys...	Specific lots may have been manufactured with insufficient or incomplete welds.	Class II	Medtronic Perfusion Systems
Apr 29, 2021	Medtronic CB4W67R20, Custom Pack CB4W67R20 Adult E, Custom Perfusion System, ...	Specific lots may have been manufactured with insufficient or incomplete welds.	Class II	Medtronic Perfusion Systems
Apr 29, 2021	Medtronic CB7J98R7, Custom Pack CB7J98R7, Custom Pack CB7J98R7 3/8 Pack, Cust...	Specific lots may have been manufactured with insufficient or incomplete welds.	Class II	Medtronic Perfusion Systems
Apr 29, 2021	Medtronic BB10R94R6, Custom Pack BB10R94R6 1/4 ECCPK, Custom Perfusion System...	Specific lots may have been manufactured with insufficient or incomplete welds.	Class II	Medtronic Perfusion Systems
Apr 29, 2021	Medtronic BB8M63R5, Custom Pack BB8M63R5 Adult ECC, Custom Perfusion system, ...	Specific lots may have been manufactured with insufficient or incomplete welds.	Class II	Medtronic Perfusion Systems
Apr 29, 2021	Medtronic CB10W63R1, Custom Pack CB10W63R1 HL 20 1/4, Custom Perfusion System...	Specific lots may have been manufactured with insufficient or incomplete welds.	Class II	Medtronic Perfusion Systems
Apr 29, 2021	Medtronic CB10W64R1, Custom Pack CB10W64R1 CH Access 3/8, Custom Perfusion Sy...	Specific lots may have been manufactured with insufficient or incomplete welds.	Class II	Medtronic Perfusion Systems
Apr 29, 2021	Medtronic CB10Y89R10, Custom Pack CB10Y89R10 ECC 3/8 A/V, Custom Perfusion Sy...	Specific lots may have been manufactured with insufficient or incomplete welds.	Class II	Medtronic Perfusion Systems
Apr 29, 2021	Medtronic HY10L28R3, Custom Pack HY10L28R3 1/4 Pack, Custom Perfusion System,...	Specific lots may have been manufactured with insufficient or incomplete welds.	Class II	Medtronic Perfusion Systems
Apr 22, 2021	NeuroTherm NT2000iX Radiofrequency (RF) Generator, Model Number RFG-NT-2000	Potential capacitor failure which typically manifests as in inability to provide output on one or...	Class II	Abbott Laboratories Inc. (St Jude Medical)
Apr 21, 2021	ELUVIA Drug-Eluting Vascular Stent System - Product Usage: indicated for impr...	One batch of the ELUVIATM Drug Eluting Vascular Stent System incorrect placement of some 6x40mm E...	Class II	Boston Scientific Corporation
Apr 20, 2021	Dialysate Concentrate for Hemodialysis-Liquid/Powd - Product Usage: used in c...	The lot may have experienced an anomaly during the manufacturing process, that could lead to an o...	Class II	Medivators, Inc.
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 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 7, 2021	Cobalt HF Quad MRI SureScan Implantable Cardioverter Defibrillators with Card...	The device may contain a manufacturing defect of a missing resistance spot weld (RSW).	Class II	Medtronic Inc., Cardiac Rhythm and Heart Failur...
Apr 6, 2021	Implantable cardiac resynchronization therapy pacemakers (CRT-P) - Product Us...	A longevity estimation error may occur in the early years of device life when a unipolar pacing ...	Class II	Medtronic Inc., Cardiac Rhythm and Heart Failur...
Apr 6, 2021	Programmers - Product Usage: used to treat arrhythmias related to bradycardia...	A longevity estimation error may occur in the early years of device life when a unipolar pacing ...	Class II	Medtronic Inc., Cardiac Rhythm and Heart Failur...
Apr 6, 2021	CRT-P Quad Models (CRT-Ps): a. Percepta CRT-P MRI: W1TR01, W1TR04, W4TR01, W...	There is a SmartSync software issue that results in an overestimation in the displayed longevity ...	Class II	Medtronic Inc., Cardiac Rhythm and Heart Failur...
Apr 6, 2021	Implantable Pulse Generators - Product Usage: used to treat arrhythmias relat...	A longevity estimation error may occur in the early years of device life when a unipolar pacing ...	Class II	Medtronic Inc., Cardiac Rhythm and Heart Failur...
Apr 6, 2021	CareLink SmartSync Device Manager - Product Usage: used to treat arrhythmias ...	A longevity estimation error may occur in the early years of device life when a unipolar pacing ...	Class II	Medtronic Inc., Cardiac Rhythm and Heart Failur...
Apr 6, 2021	CareLink SmartSync Device Manager (24970A). used to interrogate cardiac impl...	There is a SmartSync software issue that results in an overestimation in the displayed longevity ...	Class II	Medtronic Inc., Cardiac Rhythm and Heart Failur...
Mar 31, 2021	Mark 910 LogiCal, Model Number DPS567201. for blood pressure monitoring and b...	Specific lots of Medex High Pressure Adaptors, Rotators, Manifolds, Stopcocks and Tubing and Mede...	Class II	Smiths Medical ASD Inc.
Mar 31, 2021	Palm Cups - Product Usage: intended to be used to percuss the chest wall to m...	The firm became aware via complaints that one lot of ACE MDI Spacers with Small Masks and one lot...	Class II	Smiths Medical ASD Inc.
Mar 31, 2021	ANGIOGRAPHIC KIT W/MX123-3MR MANIFOLD, Model Number MX1030. for use during an...	Specific lots of Medex High Pressure Adaptors, Rotators, Manifolds, Stopcocks and Tubing and Mede...	Class II	Smiths Medical ASD Inc.
Mar 31, 2021	HIGH PRESSURE TUBING, 72IN, Model Number MX152114 (Component). Stopcocks and...	Specific lots of Medex High Pressure Adaptors, Rotators, Manifolds, Stopcocks and Tubing and Mede...	Class II	Smiths Medical ASD Inc.
Mar 31, 2021	HIGH PRESSURE ROTATOR (Component) a. WITH MALE LUER LOCK, Model Number MX49...	Specific lots of Medex High Pressure Adaptors, Rotators, Manifolds, Stopcocks and Tubing and Mede...	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.