Browse Device Recalls
1,708 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 1,708 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 1,708 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Apr 29, 2022 | NIM EMG Endotracheal Tube, Part Numbers: a) REF 8229308 b) REF 8229307 c)... | The firm received reports of events related to airway obstruction while using NIM Standard Reinfo... | Class I | Medtronic Xomed, Inc. |
| Apr 20, 2022 | The C304-HIS device features a guide wire to access the vein, a valve to redu... | The firm's internal processes identified that certain lots may have an improperly sealed barrier ... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Apr 20, 2022 | Cardioblate" Gemini"-s Irrigated RF Surgical Ablation System; The device is p... | Firm detected an increase in complaints related to fractured jaw tips of the Cardioblate Gemini-s. | Class II | Medtronic Perfusion Systems |
| Apr 14, 2022 | HeartWare HVAD Pump Implant Kit, a) Model Number 1104JP, b) Model Number MCS1... | The pump may have a welding defect that can lead the pump to malfunction. The issue is under inve... | Class I | Medtronic Inc |
| Apr 12, 2022 | Cobalt Models loaded with CareLink SmartSync Device Manager application softw... | Telemetry error that may occur with Medtronic Cobalt and Crome implantable cardioverter defibrill... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Apr 12, 2022 | Crome Models loaded with CareLink SmartSync Device Manager application softwa... | Telemetry error that may occur with Medtronic Cobalt and Crome implantable cardioverter defibrill... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Mar 30, 2022 | Instructions for Use, Patient Manuals, and Emergency Responder Guides for Hea... | Errors and inconsistencies that were identified in the Instruction for Use (IFU), Emergency Respo... | Class II | Medtronic Inc |
| Mar 30, 2022 | Percept BrainSense Implantable Neurostimulator (INS), Model B35200 | The Implantable Neurostimulator (INS) cannot communicate with the clinical programmer and/or the ... | Class II | Medtronic Neuromodulation |
| Mar 30, 2022 | Percept PC BrainSense Implantable Neurostimulator (INS) Model B35200 | The Implantable Neurostimulator (INS) cannot communicate with the clinical programmer and/or the ... | Class II | Medtronic Neuromodulation |
| Mar 30, 2022 | Vanta INS Implantable Neurostimulator. Medtronic Model 977006 Vanta with Adap... | The Implantable Neurostimulator Model may be susceptible to not communicating with the clinical p... | Class II | Medtronic Neuromodulation |
| Mar 25, 2022 | Puritan Bennett 980 Series Ventilator | The audible alarm may not sound and/or the omni-directional LED visual alarm may not display duri... | Class I | Medtronic formerly Covidien |
| Mar 23, 2022 | Medtronic IN.PACT Admiral, Paclitaxel-coated PTA Balloon Catheter, Sterile EO... | Packaging for Balloon Catheters may be damaged resulting in loss of sterility. | Class II | Medtronic Vascular, Inc. |
| Mar 23, 2022 | Medtronic IN.PACT AV, Paclitaxel-coated PTA Balloon Catheter, REF: IAV0600800... | Packaging for Balloon Catheters may be damaged resulting in loss of sterility. | Class II | Medtronic Vascular, Inc. |
| Mar 2, 2022 | Harmony Delivery Catheter System. Part of the Harmony Transcatheter Pulmonar... | There is potential for the capsule bond to break during the procedure. | Class I | Medtronic Inc |
| Feb 28, 2022 | MEDTRONIC INTERSTIM THERAPY SYSTEM FOR URINARY CONTROL, which includes the fo... | There is a software anomaly with the InterStim X Clinician software application with results in t... | Class II | Medtronic Neuromodulation |
| Feb 4, 2022 | Medtronic TurboHawk Plus Directional Atherectomy System 6F, Multi-vessel, Cat... | The device has similarities in design to another device that the firm recently issued a field cor... | Class I | ev3 Inc. |
| Feb 4, 2022 | Medtronic TurboHawk Plus Directional Atherectomy System 6F, Small Vessel, Cat... | The device has similarities in design to another device that the firm recently issued a field cor... | Class I | ev3 Inc. |
| Jan 27, 2022 | MiniMed 630G: MMT-1715, MMT-1754, MMT-1755; MiniMed 670G: MMT-1740, MMT-1741... | New or replacement insulin pumps are not pre-programmed with basal rates or other verified settin... | Class II | Medtronic MiniMed |
| Jan 18, 2022 | LINQ II Insertable Cardiac Monitor | Devices may lose functionality due to susceptibility to moisture ingress. | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Dec 22, 2021 | NIM TRIVANTAGE EMG Endotracheal Tube | There is potential for multiple issues due to a manufacturing nonconformity. | Class II | Medtronic Xomed, Inc. |
| Dec 21, 2021 | Endurant, Endurant II and Endurant IIs Stent Graft System: Medtronic Endur... | Stent Graft Systems built with specific batches of taper tip assemblies have the potential for th... | Class II | Medtronic Vascular, Inc. |
| Dec 15, 2021 | Software 1898072 IPC upgrade v 2.7.3.0, IPC System: a) CONSOLE 1898001 IPC, ... | As a result of Medtronic's integrated power console (authentication number: 222ACBZX00018000) bei... | Class II | Medtronic Xomed, Inc. |
| Dec 6, 2021 | Medtronic HawkOne Directional Atherectomy System, Catalog numbers H1-S and H1... | Reports have been received of tip damage during use of the devices which resulted in some instanc... | Class I | ev3 Inc. |
| Dec 6, 2021 | Medtronic HawkOne Directional Atherectomy System, Catalog numbers H1-M and H1... | Reports have been received of tip damage during use of the devices which resulted in some instanc... | Class I | ev3 Inc. |
| Nov 19, 2021 | Instructions for Use for all model numbers of the Medtronic Abre Venous Self-... | There have been reports of stent migration. | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Nov 19, 2021 | Distractor Rack, REF 5598007, which may be packaged in Modular Distractor Set... | Two lots of the 5598007 Distractor Rack which were not manufactured to specification. The crest w... | Class II | Medtronic Sofamor Danek USA Inc |
| Nov 11, 2021 | Stealthstation System w/ Stealthstation Cranial Software 3.1.1,3.1.2,3.1. or ... | Cranial biopsy procedure software can enter a state where the biopsy depth gauge is no longer syn... | Class I | Medtronic Navigation, Inc. |
| Nov 9, 2021 | Stealth Autoguide Tracker, Model: 28248, which is an instrument in the Stealt... | A tracker that holds and guides neurosurgical surgical instruments may be subject to separation/w... | Class II | Medtronic Navigation, Inc. |
| Nov 8, 2021 | Medical Device Identification Cards associated with Astra XT DR Implantable p... | The back of some Medical Device Identification Cards provided to patients were printed with an er... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Nov 8, 2021 | Medical Device Identification Cards associated with Sprint Quattro Lead, Prod... | The back of some Medical Device Identification Cards provided to patients were printed with an er... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Nov 4, 2021 | Medtronic Wireless Recharger Model WR9220 included in the RS5200 Recharger Ki... | The wireless rechargers (WR; WR9200 and WR9220; included in the Recharger Kits) become unresponsi... | Class II | Medtronic Neuromodulation |
| Nov 4, 2021 | Medtronic Wireless Recharger Model WR9200 included in the RS6200 Recharger Ki... | The wireless rechargers (WR; WR9200 and WR9220; included in the Recharger Kits) become unresponsi... | Class II | Medtronic Neuromodulation |
| Nov 4, 2021 | Medtronic Wireless Recharger Model WR9200 included in the RS7200 Recharger Ki... | The wireless rechargers (WR; WR9200 and WR9220; included in the Recharger Kits) become unresponsi... | Class II | Medtronic Neuromodulation |
| Oct 19, 2021 | Model B35200 - Percept PC BrainSense Implantable Neurostimulator | During cardioversion events, the Model B35200 Percept PC Implantable Neurostimulator could become... | Class II | Medtronic Neuromodulation |
| Oct 15, 2021 | Endurant IIs Stent Graft System REF/Description: ESBF2814C103EE STENT GRAFT E... | Due to, during stent graft deployment, the spindle may detach from the distal end of the spindle ... | Class II | Medtronic Vascular, Inc. |
| Oct 15, 2021 | Endurant Stent Graft System REF/Description: ENTF2525C70EE STENT GRAFT ENTF... | During stent graft deployment, the spindle may detach from the distal end of the spindle hypotube | Class II | Medtronic Vascular, Inc. |
| Oct 15, 2021 | Endurant II Stent Graft System REF/Description: ETBF2513C145EE STENT GRAFT ET... | Due to, during stent graft deployment, the spindle may detach from the distal end of the spindle ... | Class II | Medtronic Vascular, Inc. |
| Oct 12, 2021 | Medtronic CareLink SmartSync Device Manager application software (D00U005) us... | The processing of collected episode data may fail due to a software error. | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Oct 12, 2021 | Medtronic Custom Perfusion kits, with the following product descriptions and ... | Product is labeled as non-pyrogenic but endotoxin testing was not performed. | Class II | Medtronic Perfusion Systems |
| Sep 27, 2021 | Cardioblate CryoFlex Surgical Ablation Console | There is potential for intermittent electrical connectivity between the console and probe. | Class II | Medtronic Perfusion Systems |
| Sep 23, 2021 | Clinician Programmer Application (CPA) model A610 Clinician Software Application | A software anomaly may occur with the clinician programmer application. | Class II | Medtronic Neuromodulation |
| Sep 13, 2021 | Medtronic Bio-Medicus Insertion Kits, Model number 96553, Pediatric Insertion... | There was a label mix-up between two model numbers resulting in the incorrect guidewire being con... | Class II | Medtronic Perfusion Systems |
| Sep 9, 2021 | C315-HIS Delivery Catheter | Medtronic is recalling three lots of unused C315HIS Delivery Catheters due to reports of an inabi... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Sep 2, 2021 | Endoskeleton" TAS Interbody System with Titan nanoLOCK" Surface Technology, N... | Engraving on implants may not match what is listed on the pouch labels. | Class II | Medtronic Sofamor Danek USA Inc |
| Sep 2, 2021 | Endoskeleton" TCS Interbody System with Titan nanoLOCK" Surface Technology, N... | Engraving on implants may not match what is listed on the pouch labels. | Class II | Medtronic Sofamor Danek USA Inc |
| Aug 31, 2021 | Medtronic sterile single-use blades that are components of the StraightShot M... | There was an increase in complaints related to tip breaks and wobble/vibration. | Class II | Medtronic Xomed, Inc. |
| Aug 31, 2021 | Medtronic sterile single-use blades that are components of the StraightShot M... | There was an increase in complaints related to tip breaks and wobble/vibration. | Class II | Medtronic Xomed, Inc. |
| Aug 31, 2021 | Medtronic Sterile single-use blades that are components of the StraightShot M... | There was an increase in complaints related to tip breaks and wobble/vibration. | Class II | Medtronic Xomed, Inc. |
| Aug 24, 2021 | DLP Left Heart Vent Catheters, 16 FR. Sterile, Rx Only | Potential for a wire protrusion through the left heart vent catheter tip | Class II | Medtronic Perfusion Systems |
| Aug 24, 2021 | DLP Left Heart Vent Catheters, 18 FR. Sterile, Rx Only | Potential for a wire protrusion through the left heart vent catheter tip | Class II | Medtronic Perfusion Systems |
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.