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 |
|---|---|---|---|---|
| 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 |
| Aug 5, 2025 | Boston Scientific Encore Advantage Kit, Material Numbers (UPN): 1. H749045... | The Encore 26 Inflation Device is used with balloon dilation catheters to create and monitor pres... | Class II | Boston Scientific Corporation |
| Aug 5, 2025 | Boston Scientific Encore 26 Inflation Device, Material Numbers (UPN): 1. H... | The Encore 26 Inflation Device is used with balloon dilation catheters to create and monitor pres... | Class II | Boston Scientific Corporation |
| Aug 5, 2025 | Boston Scientific UroMax Ultra Kit, Material Numbers (UPN): 1. M0062251200... | The Encore 26 Inflation Device is used with balloon dilation catheters to create and monitor pres... | Class II | Boston Scientific Corporation |
| Aug 5, 2025 | Boston Scientific NephroMax Kit, Material Numbers (UPN): 1. M0062101180; ... | The Encore 26 Inflation Device is used with balloon dilation catheters to create and monitor pres... | Class II | Boston Scientific Corporation |
| Jul 29, 2025 | WATCHMAN TruSeal Access System ANT, OUS, Material Number (UPN) M635TS70040; i... | Boston Scientific has identified a higher likelihood of air embolism events when procedures are p... | Class I | Boston Scientific Corporation |
| Jul 29, 2025 | WATCHMAN TruSeal Access System ANT, US, Material Number (UPN) M635TU70040; in... | Boston Scientific has identified a higher likelihood of air embolism events when procedures are p... | Class I | Boston Scientific Corporation |
| Jul 29, 2025 | WATCHMAN FXD Curve Access System Sgl, US, Material Number (UPN) M635TU80010; ... | Boston Scientific has identified a higher likelihood of air embolism events when procedures are p... | Class I | Boston Scientific Corporation |
| Jul 29, 2025 | WATCHMAN TruSeal Access System SGL, OUS, Material Number (UPN) M635TS70010; i... | Boston Scientific has identified a higher likelihood of air embolism events when procedures are p... | Class I | Boston Scientific Corporation |
| Jul 29, 2025 | WATCHMAN TruSteer Access System, US, Material Number (UPN) M635TU90050;intend... | Boston Scientific has identified a higher likelihood of air embolism events when procedures are p... | Class I | Boston Scientific Corporation |
| Jul 29, 2025 | WATCHMAN FXD Curve Access Sys Dbl, OUS, Material Number (UPN) M635TS80020; in... | Boston Scientific has identified a higher likelihood of air embolism events when procedures are p... | Class I | Boston Scientific Corporation |
| Jul 29, 2025 | WATCHMAN TruSeal Access System DBL, OUS, Material Number (UPN) M635TS70020; i... | Boston Scientific has identified a higher likelihood of air embolism events when procedures are p... | Class I | Boston Scientific Corporation |
| Jul 29, 2025 | WATCHMAN FXD Curve Access Sys Sgl, OUS, Material Number (UPN) M635TS80010; in... | Boston Scientific has identified a higher likelihood of air embolism events when procedures are p... | Class I | Boston Scientific Corporation |
| Jul 29, 2025 | WATCHMAN TruSeal Access System DBL, US, Material Number (UPN) M635TU70020; in... | Boston Scientific has identified a higher likelihood of air embolism events when procedures are p... | Class I | Boston Scientific Corporation |
| Jul 29, 2025 | WATCHMAN FXD Curve Access System Dbl, US, Material Number (UPN) M635TU80020; ... | Boston Scientific has identified a higher likelihood of air embolism events when procedures are p... | Class I | Boston Scientific Corporation |
| Jul 29, 2025 | WATCHMAN TruSeal Access System SGL, US, Material Number (UPN) M635TU70010; in... | Boston Scientific has identified a higher likelihood of air embolism events when procedures are p... | Class I | Boston Scientific Corporation |
| Jul 24, 2025 | ENDOTAK RELIANCE G/SG, transvenous defibrillation lead, implantable cardiover... | Affected lead models may experience gradually rising LVSI measurements in association with calcif... | Class I | Boston Scientific Corporation |
| Jul 24, 2025 | RELIANCE 4-FRONT, endocardial cardioversion/defibrillation and pace/sense lea... | Affected lead models may experience gradually rising LVSI measurements in association with calcif... | Class I | Boston Scientific Corporation |
| Jul 24, 2025 | ENDOTAK RELIANCE G/SG with 4-SITE Connector, transvenous defibrillation lead,... | Affected lead models may experience gradually rising LVSI measurements in association with calcif... | Class I | Boston Scientific Corporation |
| Jul 10, 2025 | Access Thyroglobulin assay, a simultaneous one-step immunoenzymatic assay, Ca... | Access Thyroglobulin reagent lot 439163 may generate erroneously high patient results. Falsely in... | Class II | Beckman Coulter, Inc. |
| Jul 7, 2025 | Carotid WALLSTENT Monorail Endoprosthesis Closed Cell Self-Expanding Stent, s... | Certain batches are being removed due to an increase in complaints received in which physicians e... | Class I | Boston Scientific Corporation |
| Jun 27, 2025 | LYFO-DISK, M. Canis Derived from ATCC 36299, packaged as: 1) REF 0894L | KWIK-STIK REF numbers: 0894P, 0894K and LYFO DISK" 0894L may result in failure to recover the ta... | Class II | Microbiologics Inc |
| Jun 27, 2025 | LYFO-DISK, M. Canis Derived from ATCC 36299, packaged as: 1) REF 0894K (6-pa... | KWIK-STIK REF numbers: 0894P, 0894K and LYFO DISK" 0894L may result in failure to recover the ta... | Class II | Microbiologics 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.