Browse Device Recalls
1,624 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 1,624 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 1,624 FDA device recalls in MN.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Oct 17, 2024 | Abbott Navitor, Vision Technology, Transcatheter Aortic Heart Valve, 27 mm, N... | A manufacturing error resulting in acceptance of valves with a leaflet deflection value that was ... | Class II | Abbott Medical |
| Oct 17, 2024 | Abbott Navitor Titan, Vision Technology, Transcatheter Aortic Heart Valve, 3... | A manufacturing error resulting in acceptance of valves with a leaflet deflection value that was ... | Class II | Abbott Medical |
| Oct 17, 2024 | Abbott Navitor Transcatheter Aortic Heart Valve, 29 mm, NVTR-29, Sterile | A manufacturing error resulting in acceptance of valves with a leaflet deflection value that was ... | Class II | Abbott Medical |
| Oct 17, 2024 | Abbott Navitor Transcatheter Aortic Heart Valve, 27 mm, NVTR-27, Sterile | A manufacturing error resulting in acceptance of valves with a leaflet deflection value that was ... | Class II | Abbott Medical |
| Oct 10, 2024 | Boston Scientific POLARx BALLOON CATHETER ST 28MM OUS, Material Number M004CR... | Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablatio... | Class I | Boston Scientific Corporation |
| Oct 10, 2024 | Boston Scientific POLARx FIT BALLOON CATHETER ST OUS, Material Number M004CR... | Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablatio... | Class I | Boston Scientific Corporation |
| Oct 10, 2024 | Boston Scientific SMARTFREEZE CRYO CONSOLE: Console: Material Number M004... | Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablatio... | Class I | Boston Scientific Corporation |
| Oct 10, 2024 | Boston Scientific POLARx FIT BALLOON CATHETER LT OUS, Material Number M004CRB... | Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablatio... | Class I | Boston Scientific Corporation |
| Oct 10, 2024 | Boston Scientific POLARx FIT BALLOON CATHETER LT US, Material Number M004CRBS... | Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablatio... | Class I | Boston Scientific Corporation |
| Oct 10, 2024 | Boston Scientific POLARx FIT BALLOON CATHETER ST US, Material Number M004CRBS... | Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablatio... | Class I | Boston Scientific Corporation |
| Oct 10, 2024 | Boston Scientific POLARx BALLOON CATHETER LT 28MM OUS, Material Number M004CR... | Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablatio... | Class I | Boston Scientific Corporation |
| Oct 3, 2024 | Medtronic DLP Aortic Root Cannula with Flow-Guard, REF 11012; for use in card... | There is the potential for a potential sterility breach for three lots of the DLP Aortic Root Can... | Class II | Medtronic Perfusion Systems |
| Sep 30, 2024 | The Access Cortisol assay is a paramagnetic particle, chemiluminescent immun... | The Access Cortisol assay protocol file (APF) applies an incorrect calibration curve acceptance p... | Class II | Beckman Coulter, Inc. |
| Sep 24, 2024 | medex TranStar KIDS KIT 31IN. CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Devi... | Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interrupti... | Class II | Smiths Medical ASD, Inc. |
| Sep 24, 2024 | medex TranStar Disposable Transducer 1/EA, Product Code REF MX950 | Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interrupti... | Class II | Smiths Medical ASD, Inc. |
| Sep 24, 2024 | medex TranStar KIDS KIT 19IN. CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Devi... | Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interrupti... | Class II | Smiths Medical ASD, Inc. |
| Sep 24, 2024 | medex NICU Monitoring Kit Set 1/EA, Product Code REF MX20086 | Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interrupti... | Class II | Smiths Medical ASD, Inc. |
| Sep 24, 2024 | medex TranStar Kit w/ Stopcock1/EA, Product Code REF MX20740 | Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interrupti... | Class II | Smiths Medical ASD, Inc. |
| Sep 24, 2024 | medex TranStar Neonatal Monitoring Kit 10/EA, Product Code REF MX9530T | Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interrupti... | Class II | Smiths Medical ASD, Inc. |
| Sep 24, 2024 | medex TranStar 72in (183cm) Double Monitoring Kit 10/EA, Product Code REF MX9... | Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interrupti... | Class II | Smiths Medical ASD, Inc. |
| Sep 24, 2024 | medex TranStar Single OR Set 1/EA, Product Code REF MX20846R2 | Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interrupti... | Class II | Smiths Medical ASD, Inc. |
| Sep 24, 2024 | medex TranStar Single ICP Set 1/EA, Product Code REF MX20897 | Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interrupti... | Class II | Smiths Medical ASD, Inc. |
| Sep 24, 2024 | medex TranStar SINGLE 84IN SET WITH ANTI-SHUNT STOPCOCK 10/EA, Product Code R... | Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interrupti... | Class II | Smiths Medical ASD, Inc. |
| Sep 24, 2024 | medex TranStar 60in (152cm) Single Monitoring Kit 10/EA, Product Code REF MX9... | Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interrupti... | Class II | Smiths Medical ASD, Inc. |
| Sep 24, 2024 | medex TranStar 84in (213cm) Single Monitoring Kit 10/EA, Product Code REF MX9... | Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interrupti... | Class II | Smiths Medical ASD, Inc. |
| Sep 24, 2024 | Medtronic Percept RC Implantable Neurostimulators (INS), Model B35300. | A limited number of Percept RC Implantable Neurostimulators (INS), Model B35300 will not be able ... | Class II | Medtronic Neuromodulation |
| Sep 24, 2024 | medex TranStar DPT w/Two Stopcocks 10/EA, Product Code REF MX950X2SC | Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interrupti... | Class II | Smiths Medical ASD, Inc. |
| Sep 24, 2024 | medex TranStar KIDS KIT 10IN. CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Devi... | Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interrupti... | Class II | Smiths Medical ASD, Inc. |
| Sep 24, 2024 | medex TranStar MONITORING SET W/SAMPLING PORT 10/EA, Product Code REF MXG300260 | Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interrupti... | Class II | Smiths Medical ASD, Inc. |
| Sep 24, 2024 | medex TranStar Patient Mount Monitoring Kit 10/EA, Product Code REF MX9501T | Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interrupti... | Class II | Smiths Medical ASD, Inc. |
| Sep 24, 2024 | medex TranStar KIDS KIT 34IN. CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Devi... | Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interrupti... | Class II | Smiths Medical ASD, Inc. |
| Sep 24, 2024 | medex TranStar KIDS KIT 7INCH CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Devi... | Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interrupti... | Class II | Smiths Medical ASD, Inc. |
| Sep 24, 2024 | medex TranStar DPT w/Stopcock & 30cc Flush 10/EA, Product Code REF MX950SCNT | Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interrupti... | Class II | Smiths Medical ASD, Inc. |
| Sep 24, 2024 | medex TRANSTAR MONITORING KIT 1/EA, Product Code REF MX20103R1 | Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interrupti... | Class II | Smiths Medical ASD, Inc. |
| Sep 24, 2024 | medex TranStar Stopcock w/Ext. 10/EA, Product Code REF MXG300242 | Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interrupti... | Class II | Smiths Medical ASD, Inc. |
| Sep 24, 2024 | medex TranStar DPT w/Stopcock & 3cc Flush 10/EA, Product Code REF MX950SCFT | Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interrupti... | Class II | Smiths Medical ASD, Inc. |
| Sep 24, 2024 | smiths medical SurgiVet Advisor Tech Accessories, Product Code REF V2714 | Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interrupti... | Class II | Smiths Medical ASD, Inc. |
| Sep 24, 2024 | medex Arterial Kit 1/EA, Product Code REF MX7827 | Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interrupti... | Class II | Smiths Medical ASD, Inc. |
| Sep 18, 2024 | Medtronic Recharger Kits, RS6230, RS7230, and RS5220A, containing components... | The Wireless Rechargers in the kits may be unable to enter a recharging session upon first use. | Class II | Medtronic Neuromodulation |
| Sep 16, 2024 | The Graft Tube is an optional instrument which, as designed, can be filled wi... | Possible detachment of the Graft Tube shaft from the Graft Tube funnel head when it is not used a... | Class II | Spineology, Inc. |
| Sep 12, 2024 | iotaSOFT Plus Drive Unit, REF IM-05. The iotaSOFT Insertion System is intende... | Incorrect GTIN number. | Class III | Iotamotion Inc |
| Sep 11, 2024 | SynchroMed II Infusion Pump. Product Number: 8637-20 | Potential for error and inability to interrogate pump due to data corruption in the pump memory. | Class II | Medtronic Neuromodulation |
| Sep 6, 2024 | Boston Scientific myLUX Patient Application for an Apple Mobile device, Mode... | Patients using the Model 2939 myLUX Patient Application on their Apple mobile device (e.g., iPhon... | Class II | Boston Scientific Corporation |
| Sep 5, 2024 | Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO... | Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional vi... | Class II | Boston Scientific Corporation |
| Sep 5, 2024 | Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM... | Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional vi... | Class II | Boston Scientific Corporation |
| Sep 5, 2024 | Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO... | Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional vi... | Class II | Boston Scientific Corporation |
| Sep 5, 2024 | Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + INT SYSTEM... | Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional vi... | Class II | Boston Scientific Corporation |
| Sep 5, 2024 | Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + INT SYSTEM... | Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional vi... | Class II | Boston Scientific Corporation |
| Sep 5, 2024 | Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO... | Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional vi... | Class II | Boston Scientific Corporation |
| Sep 5, 2024 | Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO... | Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional vi... | Class II | Boston Scientific Corporation |
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.