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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Apr 26, 2018 | BOX KIT1095V KIT OBESITAS (Item Code KIT1095V) Product Usage: The Endo GIA ... | Device may be missing a sled component. The sled component is responsible for staple deployment. ... | Class II | COVIDIEN MEDTRONIC |
| Apr 26, 2018 | Endo GIA" 30mm Gray Curved Tip Articulating Vascular Reload with Tri-Staple" ... | Device may be missing a sled component. The sled component is responsible for staple deployment. ... | Class II | COVIDIEN MEDTRONIC |
| Apr 26, 2018 | Endo GIA" 45mm Gray Curved Tip Articulating Vascular Reload with Tri-Staple" ... | Device may be missing a sled component. The sled component is responsible for staple deployment. ... | Class II | COVIDIEN MEDTRONIC |
| Apr 26, 2018 | BOX KIT1171C KIT LAP CYSTECTOMY Product Usage: The Endo GIA universal an... | Device may be missing a sled component. The sled component is responsible for staple deployment. ... | Class II | COVIDIEN MEDTRONIC |
| Apr 26, 2018 | BOX PST03533 KIT APP STAPLER Product Usage: The Endo GIA universal and E... | Device may be missing a sled component. The sled component is responsible for staple deployment. ... | Class II | COVIDIEN MEDTRONIC |
| Apr 26, 2018 | BOX PST03699 KIT APP MED ALTERNATIV STAP Product Usage: The Endo GIA uni... | Device may be missing a sled component. The sled component is responsible for staple deployment. ... | Class II | COVIDIEN MEDTRONIC |
| Apr 26, 2018 | BOX KIT00713 KIT BY PASS Product Usage: The Endo GIA universal and Endo ... | Device may be missing a sled component. The sled component is responsible for staple deployment. ... | Class II | COVIDIEN MEDTRONIC |
| Apr 26, 2018 | (1) BOX LAPZD ZESTAW DO SG (2) BOX LAPISG1 ZESTAW DO SG (3) BOX LAPISGW... | Device may be missing a sled component. The sled component is responsible for staple deployment. ... | Class II | COVIDIEN MEDTRONIC |
| Apr 26, 2018 | (1)BOX HEMIGX1 ZESTAW DO HEMICOLECTOMII (Item Number HEMIGX1 ZESTAW DO HE... | Device may be missing a sled component. The sled component is responsible for staple deployment. ... | Class II | COVIDIEN MEDTRONIC |
| Apr 26, 2018 | BOX TGGLOGOWX1 DO TOTAL GASTRECTOMIII Product Usage: The Endo GIA univer... | Device may be missing a sled component. The sled component is responsible for staple deployment. ... | Class II | COVIDIEN MEDTRONIC |
| Apr 24, 2018 | Medtronic MiniMed Paradigm Veo Insulin Pump Product Catalog Number: MMT-554,... | The MiniMed Paradigm Veo insulin pump has an error that impacts the Arabic language translation.T... | Class II | Medtronic Inc. |
| Mar 23, 2018 | Medtronic ZEVO(TM) Anterior Cervical Plate System SLOT SCREW, REF 7710015, Si... | Slot screw had an overall length of 15mm, but per the specification, the screw should have an ove... | Class II | Medtronic Sofamor Danek USA Inc |
| Mar 23, 2018 | Visualase Cooled Laser Applicator System (VCLAS) labeled as: a. Part Num... | Medtronic has become aware that certain lots of the VCLAS 3MM, 10MM, and 15MM laser diffusing fib... | Class II | Medtronic Navigation, Inc. |
| Mar 13, 2018 | Medtronic Prestige LP(TM) Cervical Disc System with Streamlined Instruments, ... | The firm received complaints of drill bits breaking during use with the Prestige LP(TM) Cervical ... | Class II | Medtronic Sofamor Danek USA Inc |
| 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 |
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.