Browse Device Recalls

1,680 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 1,680 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 1,680 FDA device recalls.

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Date	Product	Reason	Class	Firm
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 28, 2021	Endurant II/IIs Stent Graft System: STENT GRAFT ETBF3216C145E ENDUR II BIF. ...	Incorrect stentstop assembly (18fr) was used to build the delivery system component of the device...	Class II	Medtronic Vascular, Inc.
Apr 27, 2021	Braive Growth Modulation System Break-Off Set Screws - Product Usage: intende...	Product is impacted by a thread profile defect due to a manufacturing issue.	Class II	Medtronic Sofamor Danek USA, Inc
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 25, 2021	Intellis Model 97755 Recharger - Product Usage: designed to charge the follow...	There is a potential for unintended heating that can occur with the Intellis Model 97755 Recharger.	Class II	Medtronic Neuromodulation
Mar 23, 2021	VenaSeal Closure System	Firm received increased number of reports that VenaSeal dispensing systems are not effectively ad...	Class III	Medtronic Inc.
Mar 17, 2021	Endoskeleton TC Interbody System with Titan nanoLOCK Surface Technology, 6 De...	The shelf box identifies a small device actually contains a large device, and the shelf box ident...	Class II	Medtronic Sofamor Danek USA, Inc
Mar 17, 2021	Endoskeleton TC Interbody System with Titan nanoLOCK Surface Technology, 6 De...	The shelf box identifies a small device actually contains a large device, and the shelf box ident...	Class II	Medtronic Sofamor Danek USA, Inc
Mar 16, 2021	Medtronic Abre Venous Self-expanding Sent System, Catalog number REF AB9U1608...	Incorrect size printed on the device; packaging is labeled correctly.	Class II	Medtronic Inc.
Mar 15, 2021	MiniMed 780G Insulin Pump: Models: PUMP MMT-1885 MM780G 6.5V BLE MMOL;¿ PU...	Due to a software design issue, under certain conditions, a software fault is detected when a lar...	Class II	Medtronic Minimed
Mar 15, 2021	MiniMed 670G Insulin Pump: Models: PUMP MMT-1740KX 670G V6.3 SF MG CLIN;¿ ...	Due to a software design issue, under certain conditions, a software fault is detected when a lar...	Class II	Medtronic Minimed
Mar 9, 2021	A610 Clinician Programmer Application for Deep Brain Stimulation Clinician Pr...	There are two issues within this correction action: 1. Cycling Issue: When copying settings fro...	Class II	Medtronic Neuromodulation
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
Feb 26, 2021	Medtronic, REF: MMT-7008D, Enlite Glucose Sensor for the following packaging:...	Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neop...	Class II	Medtronic Inc.
Feb 26, 2021	Medtronic REF: MMT-7020C1 Guardian Sensor (3) for the following packaging: ...	Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neop...	Class II	Medtronic Inc.
Feb 26, 2021	Medtronic REF: MMT-7008B, Enlite Glucose Sensor for the following packaging: ...	Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neop...	Class II	Medtronic Inc.
Feb 26, 2021	Medtronic, REF: MMT-7008A, Enlite Glucose Sensor for the following packaging:...	Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neopla...	Class II	Medtronic Inc.
Feb 26, 2021	Medtronic REF: MMT-7020C2 Guardian Sensor (3) for the following packaging: ...	Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neop...	Class II	Medtronic Inc.
Feb 26, 2021	Medtronic REF: MMT-7020C5 Guardian Sensor (3) for the following packaging: ...	Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neop...	Class II	Medtronic Inc.
Feb 26, 2021	Medtronic REF: MMT-7020D5 Guardian Sensor (3) for the following packaging: ...	Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neop...	Class II	Medtronic Inc.
Feb 26, 2021	Medtronic REF: MMT-7020LA, Guardian Sensor (3) for the following packaging: ...	Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neop...	Class II	Medtronic 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 REF: MMT-7020C4 Guardian Sensor (3) for the following packaging: ...	Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neop...	Class II	Medtronic 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	Medtronic REF: MMT-7020LB, Guardian Sensor (3) for the following packaging: ...	Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neop...	Class II	Medtronic Inc.
Feb 26, 2021	Medtronic REF: MMT-7020GA, Guardian Sensor (3) for the following packaging: ...	Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neop...	Class II	Medtronic 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.

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.