Browse Device Recalls
1,646 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 1,646 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 1,646 FDA device recalls in MN.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Sep 30, 2025 | IMRIS Operating Suite, iMRI 3T S, containing Siemens 3 Tesla MRI Magnet, Skyra | There is a potential safety issue associated with the magnet venting paths of the Siemens 3 Tesla... | Class I | IMPRIS Imaging Inc |
| Sep 30, 2025 | IMRIS Operating Suite, IMRIS iMRI 3T V, containing Siemens 3 Tesla MRI Magnet... | There is a potential safety issue associated with the magnet venting paths of the Siemens 3 Tesla... | Class I | IMPRIS Imaging Inc |
| Sep 30, 2025 | IMRIS Operating Suite, InVision 3T Operating Suite, containing Siemens 3 Tesl... | There is a potential safety issue associated with the magnet venting paths of the Siemens 3 Tesla... | Class I | IMPRIS Imaging Inc |
| Sep 30, 2025 | IMRIS Operating Suite, Neuro III-SV iMRI System, iMRX System, containing Siem... | There is a potential safety issue associated with the magnet venting paths of the Siemens 3 Tesla... | Class I | IMPRIS Imaging Inc |
| Sep 19, 2025 | DxC 500i Clinical Analyzer Modules, DxC 500 AU Module w/ISE, DxC 500i (Part N... | Beckman Coulter has confirmed a software anomaly on DxI 9000 Access Immunoassay Analyzer and the ... | Class II | Beckman Coulter, Inc. |
| Sep 19, 2025 | DxI 9000 Access Immunoassay Analyzer, Part Number C11137 | Beckman Coulter has confirmed a software anomaly on DxI 9000 Access Immunoassay Analyzer and the ... | Class II | Beckman Coulter, Inc. |
| Sep 12, 2025 | Affinity NT Oxygenator, Oxygenator with Balance Biosurface and Uncoated Cardi... | Medtronic identified an Affinity NT Oxygenator unit with decreased CO2 gas transfer rates that di... | Class II | Medtronic Perfusion Systems |
| Sep 10, 2025 | TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, DF, (BiD Curve D-F), ... | Abbott has become aware of a limited number of tip detachment events during catheter removal from... | Class I | Abbott |
| Sep 10, 2025 | TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, F, (UniD Curve F), RE... | Abbott has become aware of a limited number of tip detachment events during catheter removal from... | Class I | Abbott |
| Sep 10, 2025 | TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, D, (UniD Curve D), RE... | Abbott has become aware of a limited number of tip detachment events during catheter removal from... | Class I | Abbott |
| Sep 10, 2025 | TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, DD, (BiD Curve D-D), ... | Abbott has become aware of a limited number of tip detachment events during catheter removal from... | Class I | Abbott |
| Sep 10, 2025 | TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, FJ, (BiD Curve F-J), ... | Abbott has become aware of a limited number of tip detachment events during catheter removal from... | Class I | Abbott |
| Aug 20, 2025 | ACCOLADE DR SL MRI (Model L311) | Software to enhance Safety Architecture is available and designed to prevent initiation of Safety... | Class I | Boston Scientific Corporation |
| Aug 20, 2025 | Model Number S722, ALTRUA 2 DR EL Pacemaker | Software to enhance Safety Architecture is available and designed to prevent initiation of Safety... | Class I | Boston Scientific Corporation |
| Aug 20, 2025 | PROPONENT DR SL (Model L201) | Software to enhance Safety Architecture is available and designed to prevent initiation of Safety... | Class I | Boston Scientific Corporation |
| Aug 20, 2025 | ACCOLADE SR SL MRI (Model L310) | Software to enhance Safety Architecture is available and designed to prevent initiation of Safety... | Class I | Boston Scientific Corporation |
| Aug 20, 2025 | Model Number L100, ESSENTIO SR SL Pacemaker | Software to enhance Safety Architecture is available and designed to prevent initiation of Safety... | Class I | Boston Scientific Corporation |
| Aug 20, 2025 | Model Number U125, VALITUDE CRT-P EL | Software to enhance Safety Architecture is available and designed to prevent initiation of Safety... | Class I | Boston Scientific Corporation |
| Aug 20, 2025 | ACCOLADE SR SL (Model L300) | Software to enhance Safety Architecture is available and designed to prevent initiation of Safety... | Class I | Boston Scientific Corporation |
| Aug 20, 2025 | Model Number L111, ESSENTIO DR SL MRI Pacemaker | Software to enhance Safety Architecture is available and designed to prevent initiation of Safety... | Class I | Boston Scientific Corporation |
| Aug 20, 2025 | Model Number S701 ALTRUA 2 SR SL Pacemaker | Software to enhance Safety Architecture is available and designed to prevent initiation of Safety... | Class I | Boston Scientific Corporation |
| Aug 20, 2025 | ACCOLADE DR EL (Model L321) | Software to enhance Safety Architecture is available and designed to prevent initiation of Safety... | Class I | Boston Scientific Corporation |
| Aug 20, 2025 | ACCOLADE DR SL (Model L301) | Software to enhance Safety Architecture is available and designed to prevent initiation of Safety... | Class I | Boston Scientific Corporation |
| Aug 20, 2025 | Model Number L210 PROPONENT SR SL Pacemaker | Software to enhance Safety Architecture is available and designed to prevent initiation of Safety... | Class I | Boston Scientific Corporation |
| Aug 20, 2025 | Model Number U225 VISIONIST CRT-P EL | Software to enhance Safety Architecture is available and designed to prevent initiation of Safety... | Class I | Boston Scientific Corporation |
| Aug 20, 2025 | Model Number L110, ESSENTIO SR SL MRI Pacemaker | Software to enhance Safety Architecture is available and designed to prevent initiation of Safety... | Class I | Boston Scientific Corporation |
| Aug 20, 2025 | ACCOLADE DR EL MRI (Model L331) | Software to enhance Safety Architecture is available and designed to prevent initiation of Safety... | Class I | Boston Scientific Corporation |
| Aug 20, 2025 | Model Number L131, ESSENTIO DR EL MRI Pacemaker | Software to enhance Safety Architecture is available and designed to prevent initiation of Safety... | Class I | Boston Scientific Corporation |
| Aug 20, 2025 | Model Number U228, VISIONIST CRT-P EL MRI | Software to enhance Safety Architecture is available and designed to prevent initiation of Safety... | Class I | Boston Scientific Corporation |
| Aug 20, 2025 | Model Number L101, ESSENTIO DR SL Pacemaker | Software to enhance Safety Architecture is available and designed to prevent initiation of Safety... | Class I | Boston Scientific Corporation |
| Aug 20, 2025 | Model Number L231, PROPONENT DR EL MRI Pacemaker | Software to enhance Safety Architecture is available and designed to prevent initiation of Safety... | Class I | Boston Scientific Corporation |
| Aug 20, 2025 | Model Number U128, VALITUDE CRT-P EL MRI | Software to enhance Safety Architecture is available and designed to prevent initiation of Safety... | Class I | Boston Scientific Corporation |
| Aug 20, 2025 | Model Number L211 PROPONENT DR SL MRI Pacemaker | Software to enhance Safety Architecture is available and designed to prevent initiation of Safety... | Class I | Boston Scientific Corporation |
| Aug 20, 2025 | Model Number L121 ESSENTIO DR EL Pacemaker | Software to enhance Safety Architecture is available and designed to prevent initiation of Safety... | Class I | Boston Scientific Corporation |
| Aug 20, 2025 | Model Number L221 PROPONENT DR EL Pacemaker | Software to enhance Safety Architecture is available and designed to prevent initiation of Safety... | Class I | Boston Scientific Corporation |
| Aug 20, 2025 | PROPONENT SR SL (Model L200) | Software to enhance Safety Architecture is available and designed to prevent initiation of Safety... | Class I | Boston Scientific Corporation |
| Aug 20, 2025 | Model Number U226, VISIONIST CRT-P EL | Software to enhance Safety Architecture is available and designed to prevent initiation of Safety... | Class I | Boston Scientific Corporation |
| Aug 20, 2025 | Model Number L209 PROPONENT DR (VDD) SL Pacemaker | Software to enhance Safety Architecture is available and designed to prevent initiation of Safety... | Class I | Boston Scientific Corporation |
| Aug 20, 2025 | Model Number S702, ALTRUA 2 DR SL Pacemaker | Software to enhance Safety Architecture is available and designed to prevent initiation of Safety... | Class I | Boston Scientific Corporation |
| Aug 18, 2025 | Preventive Maintenance (PM) Kit ICEFX, Material Number (UPN) SPRPM8000 | Certain desiccant tube subassemblies were built with end caps that were not correctly tightened. | Class II | Boston Scientific Corporation |
| Aug 18, 2025 | ICEfx Cryoablation System, portable helium-free desktop cryoablation unit, Ma... | Certain desiccant tube subassemblies were built with end caps that were not correctly tightened. | Class II | Boston Scientific Corporation |
| Aug 6, 2025 | DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 121... | The catheters may not retain their shape. | Class I | Medtronic Perfusion Systems |
| Aug 6, 2025 | Smiths Medical CADD" Yellow Medication Cassette Reservoir with flow stop, cla... | Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag ... | Class II | ICU Medical Inc. |
| Aug 6, 2025 | Smiths Medical CADD" Medication Cassette Reservoir with flow stop, clamp and ... | Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag ... | Class II | ICU Medical Inc. |
| Aug 6, 2025 | DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 121... | The catheters may not retain their shape. | Class I | Medtronic Perfusion Systems |
| Aug 6, 2025 | Smiths Medical CADD Medication Cassette Reservoir with clamp and female Luer.... | Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag ... | Class II | ICU Medical Inc. |
| Aug 6, 2025 | Smiths Medical NRFit CADD Yellow Medication Cassette Reservoir with NRFit con... | Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag ... | Class II | ICU Medical Inc. |
| Aug 6, 2025 | Smiths Medical CADD Medication Cassette Reservoir with flow stop, clamp and f... | Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag ... | Class II | ICU Medical Inc. |
| Aug 6, 2025 | Smiths Medical CADD Medication Cassette Reservoir with clamp and female Luer.... | Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag ... | Class II | ICU Medical Inc. |
| Aug 6, 2025 | DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 121... | The catheters may not retain their shape. | Class I | 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.