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Browse Device Recalls

1,694 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 1,694 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 1,694 FDA device recalls.

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DateProductReasonClassFirm
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
Mar 13, 2014 Medtronic MiniMed Paradigm Insulin Infusion Pumps, Paradigm models: MMT-5... Medtronic is recalling the Medtronic MiniMed Paradigm Insulin Infusion Pumps because they have re... Class II Medtronic MiniMed Inc.
Mar 3, 2014 FIBERNET Embolic Protection System: Recommended Vessel Diameter 3.5 0 5.0 mm... Medtronic is recalling a specific subset of lot numbers of the FIBERNET Embolic Protection System... Class II Medtronic Vascular, Inc.
Mar 3, 2014 FIBERNET Embolic Protection System: Recommended Vessel Diameter 5.0 -6.0 mm,... Medtronic is recalling a specific subset of lot numbers of the FIBERNET Embolic Protection System... Class II Medtronic Vascular, Inc.
Mar 3, 2014 FIBERNET Embolic Protection System: Recommended Vessel Diameter 6.0 -7.0 mm,... Medtronic is recalling a specific subset of lot numbers of the FIBERNET Embolic Protection System... Class II Medtronic Vascular, Inc.
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
Feb 6, 2014 Medtronic Everest 20cc Inflation Device; Model Number and Catalog Number: AC2... Incorrect master label. Class III Medtronic Vascular
Jan 30, 2014 Medtronic Select CAP Arterial Cannulae. Vented, models 78818 (18 Fr.), 7882... Medtronic is recalling all models of its Select 3D and Select CAP Arterial Cannula product famili... Class II Medtronic Inc. Cardiac Rhythm Disease Management
Jan 30, 2014 Medtronic Select 3D Arterial Cannulae. Vented, model 78622 (22 Fr.). Non-V... Medtronic is recalling all models of its Select 3D and Select CAP Arterial Cannula product famili... Class II Medtronic Inc. Cardiac Rhythm Disease Management
Jan 30, 2014 Medtronic Intersept Custom Tubing Pack which contain Select 3D or Select CAP ... Medtronic is recalling all models of its Select 3D and Select CAP Arterial Cannula product famili... Class II Medtronic Inc. Cardiac Rhythm Disease Management
Jan 30, 2014 Medtronic Select 3D Arterial Cannulae. Vented, model 78624 (24 Fr.). Non-V... Medtronic is recalling all models of its Select 3D and Select CAP Arterial Cannula product famili... Class II Medtronic Inc. Cardiac Rhythm Disease Management
Jan 30, 2014 Medtronic Select 3D Arterial Cannulae. Vented, models 78618 (18 Fr.) and 78... Medtronic is recalling all models of its Select 3D and Select CAP Arterial Cannula product famili... Class II Medtronic Inc. Cardiac Rhythm Disease Management
Jan 30, 2014 Medtronic Select CAP Arterial Cannulae. Non-Vented, Carmeda Coated, model CB... Medtronic is recalling all models of its Select 3D and Select CAP Arterial Cannula product famili... Class II Medtronic Inc. Cardiac Rhythm Disease Management
Jan 9, 2014 Product Name: Model 7305- Mosaic Aortic Obturator The Mosaic Aortic Obtura... Medtronic, Inc. initiated a recall of Medtronic Mosaic Aortic Obturator Model 7305 used with th... Class II Medtronic Cardiovascular Surgery-the Heart Valv...
Jan 6, 2014 Medtronic GRAFTON (R) DBM, Flex 2.5cm x 10cm, REF T42100, Rx only, STERILE A,... Product was labeled as being measured as 2.5 cm x 10 cm, but contained product that measured as 2... Class II Medtronic Sofamor Danek USA Inc
Jan 3, 2014 SET SCREW RETAINING DRIVER, REF 9010000820, QTY: 1 EA, Medtronic Sofamor Dane... The retaining tabs component of the Set Screw Retaining Drive may be oversized, which will not al... Class II Medtronic Sofamor Danek USA Inc
Nov 18, 2013 CSF-Unitized Shunt, Contoured Regular, Low Pressure, Catalog No. 46022; CSF-... Medtronic Neurosurgery is recalling the CSF-Unitized Shunts, Delta Shunt Assembly Kit, and the St... Class II Medtronic Neurosurgery
Nov 18, 2013 Medtronic Strata II Shunt Assembly Kit, Small, Catalog No. 27848. Strata ... Medtronic Neurosurgery is recalling the CSF-Unitized Shunts, Delta Shunt Assembly Kit, and the St... Class II Medtronic Neurosurgery
Nov 18, 2013 Medtronic Delta Shunt Assembly Kit with Bioglide Small, Performance Level 1.0... Medtronic Neurosurgery is recalling the CSF-Unitized Shunts, Delta Shunt Assembly Kit, and the St... Class II Medtronic Neurosurgery
Nov 12, 2013 Medtronic Advanced Energy Aquamantys3 Pump Generator; Product Catalog Number:... The internal protection circuitry on the electrosurgical output that prevents a patient from expo... Class II Medtronic Advanced Energy, LLC
Oct 21, 2013 Cougar¿ Nitinol Workhorse Guidewire: Models: CGRLS190HJ, CGRLS190HS, CGRLS19... Potential for PTFE (polytetrafluroethylene) coating to delaminate and detach from Guidewire. Class I Medtronic Vascular
Oct 21, 2013 Zinger¿ Stainless Steel Workhorse Guidewire; Models: ZNGRLS180HJ, ZNGRLS180HS... Potential for PTFE (polytetrafluroethylene) coating to delaminate and detach from Guidewire. Class I Medtronic Vascular
Oct 21, 2013 THUNDER¿ Extra Support Guidewire; Models: THNDR190J, THNDR190S, THNDR300J, T... Potential for PTFE (polytetrafluroethylene) coating to delaminate and detach from Guidewire. Class I Medtronic Vascular
Oct 21, 2013 ATTAIN HYBRID¿ Guide Wire; Models: GWR419478, GWR419488, GWR419688 The Att... Potential for PTFE (polytetrafluroethylene) coating to delaminate and detach from Guidewire. Class I Medtronic Vascular
Oct 21, 2013 ZINGER¿ Steerable Guidewire; Models: LVZRLS180J, LVZRLS180S, LVZRMS180J, LVZR... Potential for PTFE (polytetrafluroethylene) coating to delaminate and detach from Guidewire. Class I Medtronic Vascular
Oct 21, 2013 ProVia¿ CROSSING GUIDEWIRE; Models: 15PROV300HS, 3PROV180HS, 3PROV180SS, 3PR... Potential for PTFE (polytetrafluroethylene) coating to delaminate and detach from Guidewire. Med... Class I Medtronic Vascular
Oct 21, 2013 COUGAR¿ Steerable Guidewire; Models: LVCLS190J, LVCLS190S, LVCXT190J, LVCXT19... Potential for PTFE (polytetrafluroethylene) coating to delaminate and detach from Guidewire. Class I Medtronic Vascular
Oct 21, 2013 THUNDER¿ Steerable Guidewire; Model: LVTNDR190S Medtronic guide wires are... Potential for PTFE (polytetrafluroethylene) coating to delaminate and detach from Guidewire. Class I Medtronic Vascular
Oct 7, 2013 Resolute Integrity Zotarolimus-eluting Coronary Stent: Stent ID 3.0 mm; Sten... A small number of units in lot number 0006573585 of the Resolute Integrity Zotarolimus-Eluting Co... Class II Medtronic Vascular, Inc.
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
Sep 16, 2013 NC Sprinter; Rapid Exchange Balloon Dilatation Catheter; Sterile; 2.25 mm; M... Compliance chart included in lot 207002011 of the NC Sprinter RX 2.25 x 12 mm products lists the ... Class II Medtronic Vascular, Inc.
Aug 23, 2013 Universal Titanium Prosthesis, Round Head, with Flex H/A titanium shoe. The e... One lot of the product was assembled using the Cam Head version of the same prosthesis instead of... Class II Medtronic Xomed, Inc.
Aug 12, 2013 T8 REMOVAL HEAD, REF 8910641, QTY: 1 EA, Product Usage: The non-sterile ... One lot of the T8 Removal Head had incorrect hardness specification, which could result in the T8... Class II Medtronic Sofamor Danek USA Inc
Jul 25, 2013 Medtronic O-arm Imaging System Mobile X-ray system. Model No. BI-700-00027 a... Review of on-system electronic product labeling and Instructions for comply with applicable Use i... Class II Medtronic Navigation, Inc.
Jul 17, 2013 Medtronic Custom Perfusion System with Trillium BioSurface (a polymer contain... Medtronic was notified that Edwards Lifesciences has initiated a product recall for the Rigid Suc... Class II Medtronic Inc. Cardiac Rhythm Disease Management
Jul 17, 2013 Medtronic Custom Perfusion System. Model Numbers: 1D80R8, 1E34R1, 1F75R1, 1... Medtronic was notified that Edwards Lifesciences has initiated a product recall for the Rigid Suc... Class II Medtronic Inc. Cardiac Rhythm Disease Management
Jul 17, 2013 Medtronic Custom Perfusion System with Carmeda BioActive Surface. Model Numb... Medtronic was notified that Edwards Lifesciences has initiated a product recall for the Rigid Suc... Class II Medtronic Inc. Cardiac Rhythm Disease Management
Jul 15, 2013 StealthStation S7 Framelink Software version 5.4. Aid for locating anatom... Medtronic Navigation, Inc. has initiated a field correction to their Framelink software version 5... Class II Medtronic Navigation, Inc.
Jul 9, 2013 Tray Surgical, ENT (various instrument trays) Used for stot age and transp... The firm will recall and replace the identified instrument trays in the field, with trays that ha... Class II Medtronic Xomed, Inc.
Jul 8, 2013 Medtronic Mullins Transseptal Adult 7F, REF 008551. Intended for the intr... Medtronic identified a specific labeling issue for specific lots of Mullins Transseptal Catheter ... Class II Medtronic Inc. Cardiac Rhythm Disease Management
Jul 3, 2013 Medtronic MiniMed Paradigm Reservoirs, Model No: MMT-326A (1.8mL) and MMT-332... Medtronic is recalling certain lots of Medtronic MiniMed Paradigm Reservoirs MMT-326A (1.8mL) and... Class II Medtronic MiniMed
Jun 28, 2013 Medtronic Preimplantation Test Kit, Catalog No. 21047. The kit is indicated f... Medtronic Neurosurgery is recalling the Medtronic Preimplantation Test Kit because the outer cart... Class II Medtronic Neurosurgery
Jun 14, 2013 Medtronic Affinity Pediatric Arterial Filter, model number S4014, sterilized ... Medtronic is recalling 148 Affinity Pediatric Arterial Filters from 2 manufacturing lots because ... Class II Medtronic Inc. Cardiac Rhythm Disease Management
Jun 12, 2013 Medtronic, Launcher Guiding Catheter, Model # LA8EBU45SH, Lot # 0006722866, ... Medtronic has identified a labeling issue for 24 units of the Launcher coronary Guide Catheter. ... Class II Medtronic Inc. Cardiac Rhythm Disease Management

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.