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 |
|---|---|---|---|---|
| Jun 21, 2018 | Percepta Quad CRT-P MRI SureScan, REF W4TR04 Product Usage: The CRT-P mod... | Potential for a device reset to occur in Percepta CRT-P MRI SureScan and Percepta Quad CRT-P MRI ... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Jun 21, 2018 | Percepta CRT-P MRI SureScan, REF W1TR01 Product Usage: The CRT-P models a... | Potential for a device reset to occur in Percepta CRT-P MRI SureScan and Percepta Quad CRT-P MRI ... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Jun 12, 2018 | Inspire II Model 3024 Implantable Pulse Generator (IPG) for Obstructive Sleep... | Incorrect use-by date on the device registration/patient file labels. | Class II | Inspire Medical Systems Inc. |
| Jun 6, 2018 | Single Chamber Temporary External Pacemaker, Model 53401 | A subset of Medtronic Model 53401 Single Chamber External Pulse Generators (EPGs) may revert from... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| May 25, 2018 | Vectris(TM) Sure Scan(R) MRI Lead Kit for Spinal Cord Stimulation, Models: (... | This voluntary recall is being conducted due to the curved tip introducer needle which is include... | Class II | Medtronic Neuromodulation |
| May 25, 2018 | Vectris(TM) Trial Screening Lead Kit for Spinal Cord Stimulation, Models: (a... | This voluntary recall is being conducted due to the curved tip introducer needle which is include... | Class II | Medtronic Neuromodulation |
| May 10, 2018 | medfusion Stopcock, 1-way and 4-way, Model Numbers (REF): a. 081-101BE b. 0... | Product has a lack of sterility assurance | Class II | Smiths Medical ASD Inc. |
| May 4, 2018 | Drainer(R) Centesis Catheters: (a) REF 8810, 5F x 9cm (b) REF 8811, 6F x 9c... | The supplier of Drainer(R) centesis catheters notified Vascular Solutions, Inc. that there is a p... | Class II | Vascular Solutions, Inc. |
| Apr 20, 2018 | LINX Reflux Management System, Implant Clasp, 13-17 Bead, 1.5T, Product Code ... | Possible out of specification condition which may allow a bead component to separate from an adja... | Class II | Torax Medical, Inc. |
| Apr 20, 2018 | LINX Reflux Management System, Implant Clasp, 13-16 Bead, 1.5T, Product Code ... | Possible out of specification condition which may allow a bead component to separate from an adja... | Class II | Torax Medical, Inc. |
| Apr 20, 2018 | LINX Reflux Management System, Implant Suture, 12-17 Bead, 0.7T, Product Code... | Possible out of specification condition which may allow a bead component to separate from an adja... | Class II | Torax Medical, Inc. |
| Apr 20, 2018 | LINX Reflux Management System, Implant Clasp, 12-17 Bead, 0.7T, Product Code ... | Possible out of specification condition which may allow a bead component to separate from an adja... | Class II | Torax Medical, Inc. |
| Apr 20, 2018 | LINX Reflux Management System, Implant Clasp, 12-17 Bead, 0.7T, Product Code ... | Possible out of specification condition which may allow a bead component to separate from an adja... | Class II | Torax Medical, Inc. |
| Apr 13, 2018 | CSI, Orbital Atherectomy System (OAS) Saline Infusion Pump, Rx only, Part Nu... | The pumps may switch to stand-by during use requiring the pump to be reset prior to continuing tr... | Class II | Cardiovascular Systems Inc |
| Apr 13, 2018 | Medfusion Syringe Infusion Pump, containing the Barrel Clamp Guide mechanism | Certain Barrel Clamp Guides may contain a ridge that could potentially lead to spring slippage, r... | Class II | Smiths Medical ASD Inc. |
| Apr 4, 2018 | IMRIS IMRI 1.5T AND 3T S System Product Usage: The IMRIS intraoperative M... | The DC power to the IFOSS collision detector control panel at your facility is being adversely af... | Class II | Deerfield Imaging, Inc. |
| Apr 2, 2018 | Bivona¿ Tracheostomy Tube Tracheostomy Tubes | Carton labeling is printed with "Sterile" indicated labeling, however the device is not sold as s... | Class II | Smiths Medical ASD Inc. |
| Mar 26, 2018 | AEQUALIS HUMERAL NAIL DRILL BIT, REF 7020140 Product Usage: The Aequalis... | Drill bit tips without new BargerGard tip protector may puncture through sterile packaging. | Class II | Tornier, Inc |
| Feb 23, 2018 | IMRIS ORT300 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 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 |
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.