Browse Device Recalls
1,677 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 1,677 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 1,677 FDA device recalls in MN.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Feb 23, 2018 | IMRIS ORT100 Table, Part Numbers: (a) 110470-000 (b) 110470-600 | The Operating Room Table may drift while in use, which could potentially result in unintended mov... | Class II | Deerfield Imaging, Inc. |
| Feb 23, 2018 | IMRIS T2X Table, Part Numbers: (a) 108000-000 (b) 108000-600 (c) 109682-00... | The Operating Room Table may drift while in use, which could potentially result in unintended mov... | Class II | Deerfield Imaging, Inc. |
| Feb 23, 2018 | IMRIS ORT200 Removable Operating Room Table, 50-60 Hz Version is intended for... | The rotational locking mechanisms on the ORT 200/300 tables fail to operate such that it cannot c... | Class II | Deerfield Imaging, Inc. |
| Feb 23, 2018 | IMRIS ORT200, Removable Operating Room Table, Part Numbers: (a) 113821-000 ... | The Operating Room Table may drift while in use, which could potentially result in unintended mov... | Class II | Deerfield Imaging, Inc. |
| Feb 23, 2018 | IMRIS ORT300, Removable Operating Room Table, Part Numbers: (a) 114093-000 ... | The Operating Room Table may drift while in use, which could potentially result in unintended mov... | Class II | Deerfield Imaging, Inc. |
| Feb 20, 2018 | IMRIS ORT100 Table, Part Number 110470-000 | The rotational locking mechanisms on the ORT 100/ T2X tables can become disengaged or unlocked wh... | Class II | Deerfield Imaging, Inc. |
| Feb 20, 2018 | IMRIS T2X Table, Part Number 109682-600 | The rotational locking mechanisms on the ORT 100/ T2X tables can become disengaged or unlocked wh... | Class II | Deerfield Imaging, Inc. |
| 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 |
| Feb 8, 2018 | Fornier Phantom Fiber(TM) Sutures: Item Number Description SMB000425 4.5 MM... | Data has shown that degradation of a raw material used in Phantom Fiber may occur more quickly th... | Class II | Tornier, Inc |
| Feb 2, 2018 | 3M Surgical Clipper Professional 9681 | Failure to follow proper charging practices can result in lithium-ion battery degradation, charac... | Class II | 3M Company - Health Care Business |
| Jan 31, 2018 | FUTURO (TM) SPORT, QUICK STRAP ANKLE SUPPORT, REF 47736GEN, UPC 0 51131 19692 6 | 3M discovered that the Futuro" Quick Strap Ankle Brace (Cat. #47736EN) and ACE" Brand Deluxe Ankl... | Class II | 3M Company - Health Care Business |
| Jan 31, 2018 | ACE (TM) BRAND, DELUXE ANKLE BRACE, 207736, UPC 0 51131 20387 7 | 3M discovered that the Futuro" Quick Strap Ankle Brace (Cat. #47736EN) and ACE" Brand Deluxe Ankl... | Class II | 3M Company - Health Care Business |
| Jan 23, 2018 | 3M Bair Hugger(M) Normothermia System, Sterile Full Access Underbody, Model 6... | Adesign change to 3M(TM) Bair Hugger(TM) Full Access Underbody Warming Blanket, Models 63500 and ... | Class II | 3M Company - Health Care Business |
| Jan 23, 2018 | 3M Bair Hugger(M) Normothermia System, Full Access Underbody Warming Blanket,... | Adesign change to 3M(TM) Bair Hugger(TM) Full Access Underbody Warming Blanket, Models 63500 and ... | Class II | 3M Company - Health Care Business |
| 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 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 11, 2017 | Boston Scientific Guider Softip XF Guide Catheter Product Usage: Is a ne... | Potential polymer material degradation. | Class II | Boston Scientific Corporation |
| Dec 7, 2017 | PROPONENT MRI Pacemaker | Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV... | Class II | Boston Scientific Corporation |
| Dec 7, 2017 | ESSENTIO MRI DR Pacemaker | Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV... | Class II | Boston Scientific Corporation |
| Dec 7, 2017 | ALTRUA 2 DR Pacemaker | Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV... | Class II | Boston Scientific Corporation |
| Dec 7, 2017 | PROPONENT VDD SL Pacemaker | Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV... | Class II | Boston Scientific Corporation |
| Dec 7, 2017 | VISIONIST X4 CRT-P Pacemaker | Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV... | Class II | Boston Scientific Corporation |
| Dec 7, 2017 | ESSENTIO EL DR Pacemaker | Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV... | Class II | Boston Scientific Corporation |
| Dec 7, 2017 | VALITUDE X4 CRT-P Pacemaker | Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV... | Class II | Boston Scientific Corporation |
| Dec 7, 2017 | ACCOLADE EL DR Pacemaker | Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV... | Class II | Boston Scientific Corporation |
| Dec 7, 2017 | ESSENTIO MRI EL DR Pacemaker | Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV... | Class II | Boston Scientific Corporation |
| Dec 7, 2017 | ESSENTIO MRI SR Pacemaker | Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV... | Class II | Boston Scientific Corporation |
| Dec 7, 2017 | ALTRUA 2 SR Pacemaker | Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV... | Class II | Boston Scientific Corporation |
| Dec 7, 2017 | ESSENTIO SR Pacemaker | Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV... | Class II | Boston Scientific Corporation |
| Dec 7, 2017 | ACCOLADE MRI SR Pacemaker | Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV... | Class II | Boston Scientific Corporation |
| Dec 7, 2017 | ACCOLADE MRI DR Pacemaker | Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV... | Class II | Boston Scientific Corporation |
| Dec 7, 2017 | PROPONENT EL DR Pacemaker | Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV... | Class II | Boston Scientific Corporation |
| Dec 7, 2017 | VALITUDE CRT-P Pacemaker | Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV... | Class II | Boston Scientific Corporation |
| Dec 7, 2017 | PROPONENT DR Pacemaker | Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV... | Class II | Boston Scientific Corporation |
| Dec 7, 2017 | ACCOLADE MRI EL DR Pacemaker | Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV... | Class II | Boston Scientific Corporation |
| Dec 7, 2017 | ALTRUA 2 EL DR Pacemaker | Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV... | Class II | Boston Scientific Corporation |
| Dec 7, 2017 | ESSENTIO DR Pacemaker | Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV... | Class II | Boston Scientific Corporation |
| Dec 7, 2017 | VISIONIST CRT-P Pacemaker | Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV... | Class II | Boston Scientific Corporation |
| Dec 7, 2017 | ACCOLADE SR Pacemaker | Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV... | Class II | Boston Scientific Corporation |
| Dec 7, 2017 | ACCOLADE DR Pacemaker | Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV... | Class II | Boston Scientific Corporation |
| Dec 7, 2017 | PROPONENT SR Pacemaker | Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV... | 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.