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.

Clear

Date	Product	Reason	Class	Firm
Oct 12, 2020	Cardioblate CryoFlex, Surgical Ablation Probe, Model Number 60SF3, PROBE 60SF...	There is a potential defect in the seals of the sterile barrier pouch used to package the CryoFle...	Class II	MEDTRONIC ATS MEDICAL, INC.
Oct 12, 2020	Cardioblate CryoFlex, Surgical Ablation Probe, Model Number 60SF2, PROBE 60SF...	There is a potential defect in the seals of the sterile barrier pouch used to package the CryoFle...	Class II	MEDTRONIC ATS MEDICAL, INC.
Oct 12, 2020	Cardioblate CryoFlex, Surgical Ablation Probe, Model Number 60CM1, CLAMP 60CM...	There is a potential defect in the seals of the sterile barrier pouch used to package the CryoFle...	Class II	MEDTRONIC ATS MEDICAL, INC.
Oct 12, 2020	Cardioblate CryoFlex, Surgical Ablation Probe, Model Number 60SF7, PROBE 60SF...	There is a potential defect in the seals of the sterile barrier pouch used to package the CryoFle...	Class II	MEDTRONIC ATS MEDICAL, INC.
Aug 25, 2020	Rashkind Balloon Septostomy Catheter, 5F, Closed end, 50 cm, Pediatric, Singl...	Subsequent failure of catheters in the field and failed quality testing	Class I	Medtronic Vascular
Aug 25, 2020	Rashkind Balloon Septostomy Catheter, 4F, Closed end, 50 cm, Pediatric, Singl...	Subsequent failure of catheters in the field and failed quality testing	Class I	Medtronic Vascular
Aug 25, 2020	Rashkind Balloon Septostomy Catheter, 6F, Recess Balloon, Closed end, 50 cm, ...	Subsequent failure of catheters in the field and failed quality testing	Class I	Medtronic Vascular
Jul 17, 2020	Restore Clinician Programmer Application Software, model number A71100, used...	The original version of the A71100 Restore Clinician Programmer Application has been identified t...	Class II	Medtronic Neuromodulation
Jul 15, 2020	The Guardian Connect App CSS7200 iOS - Product Usage: intended for use by pat...	As a result of the release of new software version to CareLink Personal website, the IOS app for ...	Class II	Medtronic Inc.
Jul 13, 2020	Medtronic SynchroMed, Model A10	The previous software application version (1.1.300) is missing a decimal separator (a comma) for ...	Class II	Medtronic Inc.
Jun 12, 2020	Software 1898072 IPC upgrade v 2.7.3.0 - Product Usage: The IPC system is ind...	During internal testing execution of the next generation of Integrated Power Console (IPC) protot...	Class II	Medtronic Xomed, Inc.
Jun 8, 2020	Accurian RF Ablation, Cannula pk, Accurian, 100mm, 18G, 10mm, CS Product Numb...	Insertion difficulty of the probes. The probe was catching on a lip inside the hub of the cannula.	Class II	Medtronic Sofamor Danek USA Inc
Jun 8, 2020	Accurian RF Ablation, Cannula pk, Accurian, 150mm, 18G, 10mm, CS Product Numb...	Insertion difficulty of the probes. The probe was catching on a lip inside the hub of the cannula.	Class II	Medtronic Sofamor Danek USA Inc
Jun 8, 2020	Accurian RF Ablation, Cannula pk, Accurian, 100mm, 20G, 10mm, CS Product Numb...	Insertion difficulty of the probes. The probe was catching on a lip inside the hub of the cannula.	Class II	Medtronic Sofamor Danek USA Inc
Jun 8, 2020	Accurian RF Ablation,Cannula pk, Accurian, 100mm, 22G, 10mm, SS Product Numbe...	Insertion difficulty of the probes. The probe was catching on a lip inside the hub of the cannula.	Class II	Medtronic Sofamor Danek USA Inc
Jun 8, 2020	Accurian RF Ablation, Cannula pk, Accurian, 100mm, 22G, 5mm, CS Product Numbe...	Insertion difficulty of the probes. The probe was catching on a lip inside the hub of the cannula.	Class II	Medtronic Sofamor Danek USA Inc
Jun 8, 2020	Accurian RF Ablation, Cannula pk, Accurian, 150mm, 20G, 10mm, CS Product Numb...	Insertion difficulty of the probes. The probe was catching on a lip inside the hub of the cannula.	Class II	Medtronic Sofamor Danek USA Inc
Jun 5, 2020	StealthStation" S7 System with Polaris Spectra Camera part number PSU 9733437...	There is a potential for specific camera units to be affected by a characterization issue during ...	Class II	Medtronic Navigation, Inc.
Jun 4, 2020	Solara CRT-P MRI, Model Numbers: a) W1TR03, b) W1TR06, c) W4TR03, d) W4TR06	There is a rare communication sequence during the first device interrogation with a SmartSync Dev...	Class II	Medtronic Inc., Cardiac Rhythm and Heart Failur...
Jun 4, 2020	Serena CRT-P MRI, Model Numbers: a) W1TR02, b) W1TR05, c) W4TR02, d) W4TR05	There is a rare communication sequence during the first device interrogation with a SmartSync Dev...	Class II	Medtronic Inc., Cardiac Rhythm and Heart Failur...
Jun 4, 2020	Azure XT SR MRI, Model Numbers: a) W1SR01 and b) W2SR01	There is a rare communication sequence during the first device interrogation with a SmartSync Dev...	Class II	Medtronic Inc., Cardiac Rhythm and Heart Failur...
Jun 4, 2020	Azure S SR MRI, Model Number W3SR01	There is a rare communication sequence during the first device interrogation with a SmartSync Dev...	Class II	Medtronic Inc., Cardiac Rhythm and Heart Failur...
Jun 4, 2020	Azure XT DR MRI, Model Numbers: a) W1DR01 and b) W2DR01	There is a rare communication sequence during the first device interrogation with a SmartSync Dev...	Class II	Medtronic Inc., Cardiac Rhythm and Heart Failur...
Jun 4, 2020	Azure S DR MRI, Model Number W3DR01	There is a rare communication sequence during the first device interrogation with a SmartSync Dev...	Class II	Medtronic Inc., Cardiac Rhythm and Heart Failur...
Jun 4, 2020	Percepta CRT-P MRI, Model Numbers: a) W1TR01, b) W1TR04, c) W4TR01, d) W4TR04	There is a rare communication sequence during the first device interrogation with a SmartSync Dev...	Class II	Medtronic Inc., Cardiac Rhythm and Heart Failur...
Jun 4, 2020	Patient Connector, Model Number 24967	There is a rare communication sequence during the first device interrogation with a SmartSync Dev...	Class II	Medtronic Inc., Cardiac Rhythm and Heart Failur...
Jun 4, 2020	CareLink SmartSync Device Manager, Model Number 24970A	There is a rare communication sequence during the first device interrogation with a SmartSync Dev...	Class II	Medtronic Inc., Cardiac Rhythm and Heart Failur...
May 12, 2020	Medtronic Confida Expandable Sheath, REF CES122230. To provide a guide for c...	Increased risk of events associated with vascular complications (bleeding, hematoma, and dissection)	Class I	Medtronic Vascular Galway DBA Medtronic Ireland
Apr 30, 2020	MiniMed 630G with SmartGuard, insulin pump, Ref/Model # MMT-1754K, MMT-1714K...	Missing solder battery connection, which could interrupt power of insulin pump.	Class II	Medtronic Inc.
Apr 30, 2020	MiniMed 640G, insulin pump, Ref/Model # MMT-1711K, MMT-1752K, MMT-1752, Rx On...	Missing solder battery connection, which could interrupt power of insulin pump.	Class II	Medtronic Inc.
Apr 30, 2020	MiniMed 670G, insulin pump, Ref/Model # MMT-1760KPK, MMT-1762KCN, MMT-1762WWK...	Missing solder battery connection, which could interrupt power of insulin pump.	Class II	Medtronic Inc.
Apr 24, 2020	Medtronic Bone Void Filler, Large - Product Usage: is an injectable, moldab...	Product may not maintain its setting characteristics for the labeled shelf-life duration. Use may...	Class II	Medtronic Sofamor Danek USA Inc
Apr 24, 2020	Extremities, Large Kit Assy, US, 15/3 - Product Usage: is an injectable, mold...	Product may not maintain its setting characteristics for the labeled shelf-life duration. Use may...	Class II	Medtronic Sofamor Danek USA Inc
Apr 24, 2020	Medtronic Bone Void Filler, Small - Product Usage: is an injectable, moldab...	Product may not maintain its setting characteristics for the labeled shelf-life duration. Use may...	Class II	Medtronic Sofamor Danek USA Inc
Apr 10, 2020	Medtronic Implantable Insulin Pump System, REF: MMT-2007D, Sterile EO, CE 045...	Internal testing results showed endotoxin-related test result did not meet specifications for im...	Class II	Medtronic Inc.
Apr 6, 2020	MEDTRONIC BONE VOID FILLER, SMALL. Product Number: C07A, UDI: 813845020504 -...	Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life dur...	Class II	Skeletal Kinetics, Llc
Apr 6, 2020	MEDTRONIC BONE VOID FILLER, LARGE. Product Number: C07B, UDI: 813845020511 -...	Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life dur...	Class II	Skeletal Kinetics, Llc
Mar 26, 2020	VERTEX SELECT MULTI AXIAL SCREW. 4.0 X 38MM MULTI AXIAL SCREW. Lot H5517628	Nonconforming product; length of the product measured shorter than the labeled length.	Class II	Medtronic Sofamor Danek USA Inc
Feb 11, 2020	Medtronic Open Pivot Aortic Valve Graft, REF 502AG25, SIZE 25 mm	Medtronic received a complaint from China that the label on the box for an Open Pivot Heart Valve...	Class II	MEDTRONIC ATS MEDICAL, INC.
Jan 30, 2020	Medtronic CareLink Encore 29901 Programmer. Used to interrogate and program...	Medtronic Conexus Telemetry has been determined to contain two primary cyber vulnerabilities: imp...	Class II	Medtronic Inc., Cardiac Rhythm and Heart Failur...
Jan 30, 2020	Medtronic CareLink 2090 Programmer. Used to interrogate and program Medtroni...	Medtronic Conexus Telemetry has been determined to contain two primary cyber vulnerabilities: imp...	Class II	Medtronic Inc., Cardiac Rhythm and Heart Failur...
Jan 28, 2020	McGRATH X3 Disposable Laryngoscope Blades-used with the McGRATH MAC Video Lar...	Blades do not fit the McGRATH MAC video laryngoscope handle or were tight fitting on the handles ...	Class II	Medtronic, PLC
Jan 14, 2020	Medtronic Simulus 750 Flexible Ring/Band Accessory Kit - Product Usage: Used ...	Demonstration Simulus Reusable Sizer Accessory Kits were being incorrectly sourced to customers. ...	Class II	Medtronic CoreValve LLC
Jan 14, 2020	Medtronic Simulus 850 Semi Rigid Ring/Band Accessory Kit Used to size a p...	Demonstration Simulus Reusable Sizer Accessory Kits were being incorrectly sourced to customers. ...	Class II	Medtronic CoreValve LLC
Dec 5, 2019	Mazor X Surgical System Positioner Type II, REF: ASM0214-02	There is a potential for the surgical system to detach from the operational room table unexpected...	Class II	Medtronic Navigation, Inc.
Nov 21, 2019	Medtronic MiniMed 670G System with SmartGuard, Ref #s/Model Number(s) - MMT-...	There have been reported incidents of a loose reservoir that can no longer be locked into the pum...	Class I	Medtronic Inc.
Nov 21, 2019	Medtronic MiniMed 620G Insulin Infusion Pump, Ref #s/Model(s) - MMT-1510, MM...	There have been reported incidents of a loose reservoir that can no longer be locked into the pum...	Class I	Medtronic Inc.
Nov 21, 2019	Medtronic MiniMed 640G Insulin Infusion Pump, Ref#s/Model(s) - MMT-1511, MMT...	There have been reported incidents of a loose reservoir that can no longer be locked into the pum...	Class I	Medtronic Inc.
Nov 21, 2019	Medtronic MiniMed 630G System with SmartGuard, Ref/Model # MMT-1515, MMT-1715...	There have been reported incidents of a loose reservoir that can no longer be locked into the pum...	Class I	Medtronic Inc.
Nov 15, 2019	O-arm" O2 Imaging System, Product Number/CFN: BI-700-02000	Due to a manufacturing issue affecting particular O-arm" O2 Imaging Systems, Medtronic has determ...	Class II	Medtronic Navigation, Inc.-Littleton

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.