Browse Device Recalls
1,730 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 1,730 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 1,730 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Mar 13, 2018 | Medtronic DxTerity Diagnostic Catheter, JL 4.0, REF DXT5JL40, marked with 6F ... | The color coded French size indicator on the outer box may incorrectly reflect a 6 French size, r... | Class II | Medtronic Vascular |
| Feb 8, 2018 | BIO CAL(R) Temperature Controller, Models: (a) 370, (b) 370I Product Usage... | Medtronic has been unable to develop a cleaning protocol to satisfy current industry concerns and... | Class II | Medtronic Perfusion Systems |
| Jan 25, 2018 | O-arm 1000 mobile image-intensified fluoroscopic x-ray system; (1) Model: BAS... | Software update ("SW Update 3.2.1") is being implemented to address the following issues: Inabili... | Class II | Medtronic Navigation, Inc.-Littleton |
| Jan 16, 2018 | Medtronic TRILLIUM AFFINITY NT, Cardiotomy/Venous Reservoir (CVR) with Filter... | Possible sterile barrier breach in the pouch of Affinity NT Cardiotomy Venous Reservoir stand alo... | Class II | Medtronic Perfusion Systems |
| Jan 16, 2018 | Medtronic AFFINITY NT, Cardiotomy/Venous Reservoir (CVR) with Filter, 540 ... | Possible sterile barrier breach in the pouch of Affinity NT Cardiotomy Venous Reservoir stand alo... | Class II | Medtronic Perfusion Systems |
| Jan 3, 2018 | Medtronic Custom Perfusion Systems, indicated for use in the extracorporeal c... | Medtronic custom perfusion tubing packs contain Terumo OPS valves that were recalled due to a lac... | Class II | Medtronic Perfusion Systems |
| Dec 22, 2017 | Medtronic ANGLED DRILL, REF 6630902, QTY: 1 EA Rx only | Medtronic has discovered the product lot in question was noted as having a longer drill tip exten... | Class II | Medtronic Sofamor Danek USA Inc |
| Dec 20, 2017 | Model #: CG8900, Medtronic Clip Gun Scalp Clip Kit (Qty 1); Model #: CG8901, ... | Medtronic is initiating a voluntary recall because the products identified above did not adequate... | Class II | Medtronic Neurosurgery |
| Dec 19, 2017 | Cardiac Resynchronization Therapy Defibrillators (CRT-Ds), Claria MRI. Label... | Possible prevention of high and low voltage therapy in Medtronic Implantable Cardioverter Defibri... | Class I | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Dec 19, 2017 | Cardiac Resynchronization Therapy Defibrillators (CRT-Ds), Amplia MRI. Label... | Possible prevention of high and low voltage therapy in Medtronic Implantable Cardioverter Defibri... | Class I | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Dec 19, 2017 | Cardiac Resynchronization Therapy Defibrillators (CRT-Ds), Compia MRI. Label... | Possible prevention of high and low voltage therapy in Medtronic Implantable Cardioverter Defibri... | Class I | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Dec 19, 2017 | Implantable Cardioverter Defibrillators (ICDs), Visia AF MRI. Labeled as the ... | Possible prevention of high and low voltage therapy in Medtronic Implantable Cardioverter Defibri... | Class I | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Dec 19, 2017 | Cardiac Resynchronization Therapy Defibrillators (CRT-Ds), Viva. Labeled as ... | Possible prevention of high and low voltage therapy in Medtronic Implantable Cardioverter Defibri... | Class I | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Dec 19, 2017 | Implantable Cardioverter Defibrillators (ICDs), Visia AF. Labeled as: a. V... | Possible prevention of high and low voltage therapy in Medtronic Implantable Cardioverter Defibri... | Class I | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Dec 19, 2017 | Implantable Cardioverter Defibrillators (ICDs), Evera. Labeled as the followi... | Possible prevention of high and low voltage therapy in Medtronic Implantable Cardioverter Defibri... | Class I | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Dec 19, 2017 | Implantable Cardioverter Defibrillators (ICDs), Evera MRI. Labeled as the fo... | Possible prevention of high and low voltage therapy in Medtronic Implantable Cardioverter Defibri... | Class I | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Dec 6, 2017 | Medtronic KYPHON(R) Express(TM) Directional Bone Filler Device, SIZE 2, REF F... | Medtronic has discovered the directional arrow at the proximal end of the instrument may not corr... | Class II | Medtronic Sofamor Danek USA Inc |
| Nov 3, 2017 | Everflex Self-Expanding Peripheral Stent with Entrust Delivery System Inten... | Stent length on the label may not match the length of the stent itself. | Class II | Medtronic Inc. |
| Oct 24, 2017 | Argyle Suction Tubing (Product # 8888301515) Argyle Suction Tubing is an ... | Incorrect packaging. In one lot of Argyle Suction Tubing, the pouch may be incorrectly labeled as... | Class II | Medtronic Minimally Invasive Therapies Group |
| Oct 14, 2017 | MAHURKAR"* Elite 12 FR x 16cm Acute Dual Lumen Dialysis Catheter with Curved... | Medtronic is voluntarily recalling one lot of its MAHURKAR"* Elite 12 FR x 16cm Acute Dual Lumen... | Class II | Medtronic Minimally Invasive Therapies Group |
| Oct 10, 2017 | Medtronic CareLink iPro Therapy Management Software, MMT-7340 The CareLink... | Due to a time conversion error, data uploaded from the iPro(TM)2 recorder to the CareLink iPro so... | Class II | Medtronic Inc. |
| Sep 30, 2017 | O-arm¿ O2 interventional fluoroscopic x-ray system; Catalog Number: B1-700-02... | During servicing of certain internal components of the O-Arm O2 Surgical Imaging System, it is po... | Class II | Medtronic Navigation, Inc.-Littleton |
| Sep 26, 2017 | 6F Taiga Guiding Catheter | Complaints regarding 6F Taiga guide catheter tip detachment and/or tip splitting. | Class I | Medtronic Inc |
| 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 |
| Sep 13, 2017 | Medtronic Aptus Heli-FX Thoracic EndoAnchor System Heli-FX Guide 42 mm, REF H... | It was determined that the deflection length indicated on the Guide catheter handle does not matc... | Class II | Medtronic Vascular, Inc. |
| Sep 10, 2017 | Medtronic MiniMed(TM) Quick-set(TM) (MMT-394, 394T, 399, 399T, 387, 387T, 398... | Medtronic MiniMed(TM) Infusion Sets have the potential for over-delivery of Insulin. | Class II | Medtronic Inc. |
| Sep 10, 2017 | Medtronic MiniMed(TM) Mio(TM) (MMT-921, 921T, 923, 923T, 925, 925T, 941, 941T... | Medtronic MiniMed(TM) Infusion Sets have the potential for over-delivery of Insulin. | Class II | Medtronic Inc. |
| Sep 10, 2017 | Medtronic MiniMed(TM) Silhouette(TM) (MMT-377, 377T, 378, 378T, 384, 384T, 36... | Medtronic MiniMed(TM) Infusion Sets have the potential for over-delivery of Insulin. | Class II | Medtronic Inc. |
| Sep 10, 2017 | Medtronic MiniMed(TM) Sure-T(TM) (MMT-862, 862T, 864, 864T, 866, 866T, 874, 8... | Medtronic MiniMed(TM) Infusion Sets have the potential for over-delivery of Insulin. | Class II | Medtronic Inc. |
| Sep 10, 2017 | Medtronic MiniMed(TM) Pro-set(TM) (MMT-280, 281) | Medtronic MiniMed(TM) Infusion Sets have the potential for over-delivery of Insulin. | Class II | Medtronic Inc. |
| 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 |
| Jul 27, 2017 | VCLAS (Visualase Cooled Laser Ablation System) Part Number: 9735559 Visuala... | The VCLAS 3mm, 10mm, and 15mm tip devices were not appropriately tested for saline leakage during... | Class II | Medtronic Navigation, Inc. |
| Jul 17, 2017 | Covidien Vistec" X-Ray Detectable Sponges, 7317 Vistec" X-Ray Detectable Spon... | Medtronic is voluntarily recalling two production lots of its Covidien Vistec" x-ray detectable s... | Class II | Covidien LP |
| Jul 14, 2017 | MyCareLink Patient Monitors. It is intended for used with a compatible Med... | Patients monitored on two (2) or more implanted Medtronic heart devices in the Medtronic CareLink... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failure |
| Jul 14, 2017 | MyCareLink Smart Patient Monitors. It is intended for use with a compatibl... | Patients monitored on two (2) or more implanted Medtronic heart devices in the Medtronic CareLink... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failure |
| Jul 13, 2017 | Euphora Rapid Exchange Balloon Dilatation Catheter, a Percutaneous Translumin... | Stylette removal difficulties on the Euphora and Solarice products. | Class II | Medtronic Vascular Galway DBA Medtronic Ireland |
| Jul 13, 2017 | Solarice Rapid Exchange Balloon Dilatation Catheter, a Percutaneous Translumi... | Stylette removal difficulties on the Euphora and Solarice products. | Class II | Medtronic Vascular Galway DBA Medtronic Ireland |
| Jun 29, 2017 | SORIN GROUP, SMART PERFUSION PACK, SMART VENOUS VACUUM, REF 084118102, STERIL... | Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged ... | Class II | Sorin Group USA, Inc. |
| Jun 29, 2017 | SORIN GROUP, SMART PERFUSION PACK, NEONATE/PEDIATRIC PACK, REF 627127702, STE... | Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged ... | Class II | Sorin Group USA, Inc. |
| Jun 29, 2017 | STERILE SAMPLE SORIN GROUP, SMART PERFUSION PACK, NEONATE/PEDIATRIC PACK, REF... | Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged ... | Class II | Sorin Group USA, Inc. |
| Jun 29, 2017 | SORIN GROUP, SMART PERFUSION PACK, SMART 3/16" PEDS PACK, REF 627263601, STER... | Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged ... | Class II | Sorin Group USA, Inc. |
| Jun 29, 2017 | SORIN GROUP, SMART PERFUSION PACK, LONG PACK, REF 088512600, STERILE EO, Rx O... | Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged ... | Class II | Sorin Group USA, Inc. |
| Jun 29, 2017 | Medtronic Straight Suction 9733449 EM ENT, reusable, Rx. The firm name on th... | The instruments are not able to pass instrument verification which is performed prior to the use ... | Class II | Medtronic Navigation, Inc. |
| Jun 29, 2017 | NON-STERILE SAMPLE, SORIN GROUP, SMART CARDIOPLEGIA, CARDIOPLEGIA PACK, REF 6... | Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged ... | Class II | Sorin Group USA, Inc. |
| Jun 29, 2017 | Medtronic Curved Suction 70 9733450 EM ENT, reusable, Rx. The firm name on t... | The instruments are not able to pass instrument verification which is performed prior to the use ... | Class II | Medtronic Navigation, Inc. |
| Jun 29, 2017 | Spine Referencing Instrumentation, Spinous Process Clamp, Short When used wi... | Potential for Spinal Clamps to be damaged when opened beyond intended limits, either no opening o... | Class II | Medtronic Navigation, Inc. |
| Jun 29, 2017 | NON-STERILE SAMPLE, SORIN GROUP, SMART PERFUSION PACK, INSPIRE 8FS, REF 04404... | Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged ... | Class II | Sorin Group USA, Inc. |
| Jun 29, 2017 | Medtronic Instrument Kit 9733908 Fusion ENT, reusable, RX. This kit includes... | The instruments are not able to pass instrument verification which is performed prior to the use ... | Class II | Medtronic Navigation, Inc. |
| Jun 29, 2017 | SORIN GROUP, SMART PERFUSION PACK, PUMP AND TABLE PACK, REF 627374101, STERIL... | Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged ... | Class II | Sorin Group USA, Inc. |
| Jun 29, 2017 | Spine Referencing Instrumentation, Spinous Process Clamp, Tall When used wit... | Potential for Spinal Clamps to be damaged when opened beyond intended limits, either no opening o... | Class II | Medtronic Navigation, 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.