Browse Device Recalls

95 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 95 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 95 FDA device recalls.

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Date	Product	Reason	Class	Firm
Oct 11, 2019	Synchromed II programmable pump, Model numbers 8637-20 and 8637-40	There is a potential for the presence of a foreign particle inside the pump motor assembly which ...	Class I	Medtronic Neuromodulation
May 15, 2019	InterStim(TM) System, Model Numbers: a) TH90G01 b) TH90GFA c) TH90G02 d) ...	There is a potential for an unexpected increase in stimulation during InterStim programming with ...	Class II	Medtronic Neuromodulation
May 25, 2018	Vectris(TM) Sure Scan(R) MRI Lead Kit for Spinal Cord Stimulation, Models: (...	This voluntary recall is being conducted due to the curved tip introducer needle which is include...	Class II	Medtronic Neuromodulation
May 25, 2018	Vectris(TM) Trial Screening Lead Kit for Spinal Cord Stimulation, Models: (a...	This voluntary recall is being conducted due to the curved tip introducer needle which is include...	Class II	Medtronic Neuromodulation
Sep 21, 2017	Medtronic Ascenda(R) Intrathecal Catheter, Models: (a) 8780, UDI: 006431692...	There is a possibility that specific lots of catheters that have recently been distributed may be...	Class III	Medtronic Neuromodulation
Aug 9, 2017	Medtronic Synchromed II Model 8637 supplied in 20mL and 40 mL reservoir size ...	Medtronic implemented a final design change intended to address the motor stall due to corrosion ...	Class II	Medtronic Neuromodulation
Mar 17, 2017	DBS Lead Depth Stop contained in Medtronic Deep Brain Stimulation (DBS) lead ...	Medtronic received reports that the DBS depth stop did not adequately secure to the lead, which c...	Class II	Medtronic Neuromodulation
Feb 9, 2017	SynchroMed II implantable drug infusion pump, Model 8637-40,	Medtronic received a complaint that there was an error code displayed on the programmer when the...	Class II	Medtronic Neuromodulation
Oct 3, 2016	Model 37751 Recharger Product Usage: The Medtronic 37751 Recharger is a h...	Medtronic has identified an increased number of complaints from customers involving reports of Re...	Class II	Medtronic Neuromodulation
Oct 3, 2016	Medtronic SynchroMed II Implantable Drug Infusion System. This system includ...	Medtronic is following up to a May 2013 communication regarding the Priming Bolus function for th...	Class I	Medtronic Neuromodulation
Jun 23, 2016	DBS Pocket Adaptor, Model 64001 and Model 64002. The Medtronic Models 6400...	Due to the potential for pocket adaptor conductor wire fractures involving DBS Pocket Adaptor Mod...	Class II	Medtronic Neuromodulation
Jun 10, 2016	Medtronic, Lead Kit for DBS Stimulation. Model Numbers 3387S-40 (p/n 3387S000...	Medtronic has voluntarily decided to retrieve unused Model 3387S-40 and 3389S-40 DBS leads from t...	Class II	Medtronic Neuromodulation
May 3, 2016	Medtronic RestoreSensor, Model 37714; and, RestoreSensor SureScan, (MRI), Mod...	Loss of therapy during recharging of device. Reportedly, a charging session was terminated prior ...	Class II	Medtronic Neuromodulation
Feb 9, 2016	Medtronic, Model 8781 Ascenda" Intrathecal Catheter kit, Rx Only, Sterile Eth...	Medtronic Neuromodulation is initiating a voluntary removal of a single Model 8781 Ascenda" Intra...	Class II	Medtronic Neuromodulation
Jan 11, 2016	Specify 5-6-5 Lead, Specify 2x8 Lead, Model Numbers: 39565, 39286. Spinal co...	Some Specify 5-6-5 and 2x8 surgical lead product labeling does not adequately distinguish between...	Class II	Medtronic Neuromodulation
Apr 16, 2015	Medtronic DBS Extension Kit for Deep Brain Stimulation, Models 37085 and 370...	Medtronic is providing Important information regarding extension handling during implant procedur...	Class II	Medtronic Neuromodulation
Apr 10, 2015	Medtronic SynchroMed II Implantable Infusion Pumps, models 8637-20 and 8637-4...	Medtronic is conducting a recall of a specific subset of Model 8637-20 and 8637-40 SynchroMed II ...	Class II	Medtronic Neuromodulation
Jan 9, 2015	The Medtronic, Quadripolar ITREL 3 IPG, Model 7425, is a multiprogrammable de...	Current labeling indicates that cycling improves device longevity in every programming scenario. ...	Class II	Medtronic Neuromodulation
Jul 14, 2014	Medtronic, Activa PC, Model 37601, Method of Sterilization: Ethylene Oxide, S...	Medtronic is recalling six Activa PC (model 37601) Implantable Neurostimulators due to the potent...	Class II	Medtronic Neuromodulation
Jul 11, 2014	Medtronic Ascenda Intrathecal Catheter models 8780 and 8781, and Ascenda Intr...	Medtronic is removing specific lots of the Ascenda Intrathecal Catheters and Revision Kits, which...	Class II	Medtronic Neuromodulation
Jun 11, 2014	Medtronic Nexdrive Micropositioning Drive. Models Ml-1000 and Ml-2000. F...	Potential for misalignment of the Z-stage scale. Using one of these devices for a procedure could...	Class II	Medtronic Neuromodulation
May 2, 2014	Medtronic Model 8780 Ascenda Intrathecal Catheter. The implantable Medtron...	Medtronic has determined that an Ascenda catheter kit may have had endotoxin in excess of USP lim...	Class II	Medtronic Neuromodulation
Apr 4, 2014	Refill Kit 8551/856X (includes Models 8561, 8562 and 8564) for use with Medtr...	Some refill kits in the affected lots may contain an extension tubing set that is occluded and he...	Class II	Medtronic Neuromodulation
Feb 27, 2014	Medtronic, External neurostimulator, ENS (37021) & ENS (37022). Including t...	Medtronic neurostimulators (used with pain and deep brain stimulation therapy) have a cycling fea...	Class II	Medtronic Neuromodulation
Feb 27, 2014	Medtronic neurostimulators. Restore (37711), RestoreADVANCED (37713), Restore...	Medtronic neurostimulators (used with pain and deep brain stimulation therapy) have a cycling fea...	Class II	Medtronic Neuromodulation
Feb 27, 2014	Medtronic Activa RC (37612), Activa PC (37601), Activa SC (37602), Activa SC...	Medtronic neurostimulators (used with pain and deep brain stimulation therapy) have a cycling fea...	Class II	Medtronic Neuromodulation
Feb 26, 2014	Medtronic SynchroMed¿ II Implantable Drug Infusion Pump, Model 8637-20, 8637-...	This recall provides important new information regarding overinfusion associated with the Medtron...	Class II	Medtronic Neuromodulation
Sep 30, 2013	Medtronic Activa PC, model 37601, and Activa RC, model 37612, Activa SC, mode...	Medtronic notified customers regarding Loss of Stimulation of specific Implantable Neuro-Stimulat...	Class II	Medtronic Neuromodulation
Sep 30, 2013	Medtronic Activa PC, model 37601, and Activa RC, model 37612, Multi-program R...	Medtronic notified customers regarding over stimulation or stimulation in the wrong area related ...	Class II	Medtronic Neuromodulation
Sep 30, 2013	Medtronic RestoreUltra, model 37712, and RestoreSensor, model 37714, Multi-pr...	Medtronic notified customers regarding Loss of Stimulation of specific Implantable Neuro-Stimulat...	Class II	Medtronic Neuromodulation
Sep 30, 2013	Medtronic RestoreUltra, model 37712, and RestoreSensor, model 37714, Multi-pr...	Medtronic notified customers regarding over stimulation or stimulation in the wrong area related ...	Class II	Medtronic Neuromodulation
Jun 3, 2013	Medtronic SynchroMed EL Programmable pumps, Models 8626, 8626L, 8627, 8627L, ...	Medtronic Neuromodulation is providing Healthcare Providers with safety information and patient m...	Class I	Medtronic Neuromodulation
Jun 3, 2013	Medtronic INDURA 1P Intrathecal Catheter, model 8709SC. Contents: 81.4-cm c...	The Sutureless Connector (SC) Intrathecal Catheter connector has been redesigned to reduce the po...	Class I	Medtronic Neuromodulation
Jun 3, 2013	Medtronic SynchroMed II, Model 8637, (The SynchroMed II Pump is supplied in 2...	Medtronic is providing Healthcare Professionals with important safety information and patient man...	Class I	Medtronic Neuromodulation
Jun 3, 2013	Medtronic SynchroMed EL Programmable pumps, Models 8626, 8626L, 8627, 8627L, ...	Medtronic is providing Healthcare Professionals with important safety information and patient man...	Class I	Medtronic Neuromodulation
Jun 3, 2013	Medtronic Intrathecal Catheter Pump Segment Revision Kit, model 8596SC. Cont...	The Sutureless Connector (SC) Intrathecal Catheter connector has been redesigned to reduce the po...	Class I	Medtronic Neuromodulation
Jun 3, 2013	Medtronic SynchroMed II, Model 8637, (The SynchroMed II Pump is supplied in 2...	Medtronic Neuromodulation is providing Healthcare Providers with safety information and patient m...	Class I	Medtronic Neuromodulation
Jun 3, 2013	Medtronic Sutureless Pump Connector Revision Kit, model 8578. Contents: cat...	The Sutureless Connector (SC) Intrathecal Catheter connector has been redesigned to reduce the po...	Class I	Medtronic Neuromodulation
Jun 3, 2013	Medtronic Intrathecal Catheter, model 8731SC. Contents: 38.1-cm spinal segm...	The Sutureless Connector (SC) Intrathecal Catheter connector has been redesigned to reduce the po...	Class I	Medtronic Neuromodulation
Feb 27, 2013	Medtronic Prostiva RF Therapy Generator. The Prostiva RF system is indicat...	Medtronic has found through device testing that if the optional footswitch is not connected to th...	Class II	Medtronic Neuromodulation
Feb 8, 2013	Medtronic DBS Lead Kit for Deep Brain Stimulation, models 3387, 3387S, 3389, ...	There is a potential for lead damage due to the use of the lead cap provided in DBS and Dystonia ...	Class I	Medtronic Neuromodulation
Feb 8, 2013	Medtronic DBS Therapy for Dystonia Kit, models 3317, 3319, 3337 and 3339. S...	There is a potential for lead damage due to the use of the lead cap provided in DBS and Dystonia ...	Class I	Medtronic Neuromodulation
Dec 3, 2012	Medtronic, DBS Extension Kit for Deep Brain Stimulation, Catalog # 7482, 3708...	Medtronic has identified 140 Restore DBS Extension Kits (model numbers 7482, 37085, and 37086), w...	Class II	Medtronic Neuromodulation
Nov 9, 2012	Medtronic SynchroMed II, Model 8637, (The SynchroMed¿ II Pump is supplied in ...	Medtronic notified Healthcare Professionals of the impact of unapproved drugs on the performance ...	Class I	Medtronic Neuromodulation
Nov 9, 2012	SynchroMed EL, models 8626-10, 8626L-10, 8626-18, 8626L-18, 8627-10, 8627L-10...	Medtronic notified Healthcare Professionals of the impact of unapproved drugs on the performance ...	Class I	Medtronic Neuromodulation

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.