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 |
|---|---|---|---|---|
| Jul 17, 2013 | Medtronic Custom Perfusion System. Model Numbers: 1D80R8, 1E34R1, 1F75R1, 1... | Medtronic was notified that Edwards Lifesciences has initiated a product recall for the Rigid Suc... | Class II | Medtronic Inc. Cardiac Rhythm Disease Management |
| Jul 17, 2013 | Medtronic Custom Perfusion System with Carmeda BioActive Surface. Model Numb... | Medtronic was notified that Edwards Lifesciences has initiated a product recall for the Rigid Suc... | Class II | Medtronic Inc. Cardiac Rhythm Disease Management |
| Jul 15, 2013 | Boston Scientific, ENERGEN DR ICD, Model E143. The device is an Implantable C... | Boston Scientific CRM manufacturing quality system recently discovered test artifacts (related to... | Class II | Boston Scientific CRM Corp |
| Jul 8, 2013 | Medtronic Mullins Transseptal Adult 7F, REF 008551. Intended for the intr... | Medtronic identified a specific labeling issue for specific lots of Mullins Transseptal Catheter ... | Class II | Medtronic Inc. Cardiac Rhythm Disease Management |
| Jul 2, 2013 | MICROTEK(TM) MEDICAL BUR HOLE LATEX FREE PROBE COVER WITH GEL, featuring IsoS... | Certain lots of these Bur Hole Probe Covers did not undergo endotoxin (LAL) testing to the proper... | Class II | Ecolab Inc |
| Jul 2, 2013 | MICROTEK(TM) MEDICAL BUR HOLE LATEX PROBE COVER W/ GEL, featuring IsoSilk(R),... | Certain lots of these Bur Hole Probe Covers did not undergo endotoxin (LAL) testing to the proper... | Class II | Ecolab Inc |
| Jul 2, 2013 | Vital CARE(TM) REPS INC. ULTRASOUND PROBE COVER, BUR HOLE COVER, 5 x 96, RE... | Certain lots of these Bur Hole Probe Covers did not undergo endotoxin (LAL) testing to the proper... | Class II | Ecolab Inc |
| Jul 2, 2013 | MICROTEK(TM) MEDICAL BUR HOLE LATEX PROBE COVER WITH GEL, featuring IsoSilk(R... | Certain lots of these Bur Hole Probe Covers did not undergo endotoxin (LAL) testing to the proper... | Class II | Ecolab Inc |
| Jul 2, 2013 | MICROTEK(TM) MEDICAL BUR HOLE LATEX FREE PROBE COVER, featuring IsoSilk(R), 1... | Certain lots of these Bur Hole Probe Covers did not undergo endotoxin (LAL) testing to the proper... | Class II | Ecolab Inc |
| Jul 2, 2013 | MICROTEK(TM) MEDICAL BUR HOLE LATEX FREE PROBE COVER W/ GEL, featuring IsoSil... | Certain lots of these Bur Hole Probe Covers did not undergo endotoxin (LAL) testing to the proper... | Class II | Ecolab Inc |
| Jun 26, 2013 | Mar Cor Purification Millenium HX Portable Reverse Osmosis System. Model 302... | High inlet water pressure beyond specification and the solenoid valve does not meet application w... | Class II | Mar Cor Purification |
| Jun 14, 2013 | Medtronic Affinity Pediatric Arterial Filter, model number S4014, sterilized ... | Medtronic is recalling 148 Affinity Pediatric Arterial Filters from 2 manufacturing lots because ... | Class II | Medtronic Inc. Cardiac Rhythm Disease Management |
| Jun 12, 2013 | Medtronic, Launcher Guiding Catheter, Model # LA8EBU45SH, Lot # 0006722866, ... | Medtronic has identified a labeling issue for 24 units of the Launcher coronary Guide Catheter. ... | Class II | Medtronic Inc. Cardiac Rhythm Disease Management |
| Jun 7, 2013 | Medtronic, Consulta¿ CRT-P, Model C4TR01, C3TR01 (not approved for US), and... | Medtronic recently identified an issue with a subset of Consulta¿ CRT-P and Syncra¿ CRT-P devices... | Class II | Medtronic Inc. Cardiac Rhythm Disease Management |
| Jun 5, 2013 | 3M ESPE, Unitek Stainless Steel Permanent Molar Crowns Stainless Steel Cro... | 3M is recalling specific lots of 3M ESPE Unitek Primary Stainless Steel Crowns - Series UR4 cont... | Class III | 3M Company - Health Care Business |
| Jun 3, 2013 | Medtronic SynchroMed EL Programmable pumps, Models 8626, 8626L, 8627, 8627L, ... | Medtronic Neuromodulation is providing Healthcare Providers with safety information and patient m... | Class I | Medtronic Neuromodulation |
| Jun 3, 2013 | Medtronic INDURA 1P Intrathecal Catheter, model 8709SC. Contents: 81.4-cm c... | The Sutureless Connector (SC) Intrathecal Catheter connector has been redesigned to reduce the po... | Class I | Medtronic Neuromodulation |
| Jun 3, 2013 | Medtronic SynchroMed II, Model 8637, (The SynchroMed II Pump is supplied in 2... | Medtronic is providing Healthcare Professionals with important safety information and patient man... | Class I | Medtronic Neuromodulation |
| Jun 3, 2013 | Medtronic SynchroMed EL Programmable pumps, Models 8626, 8626L, 8627, 8627L, ... | Medtronic is providing Healthcare Professionals with important safety information and patient man... | Class I | Medtronic Neuromodulation |
| Jun 3, 2013 | Medtronic Intrathecal Catheter Pump Segment Revision Kit, model 8596SC. Cont... | The Sutureless Connector (SC) Intrathecal Catheter connector has been redesigned to reduce the po... | Class I | Medtronic Neuromodulation |
| Jun 3, 2013 | Medtronic SynchroMed II, Model 8637, (The SynchroMed II Pump is supplied in 2... | Medtronic Neuromodulation is providing Healthcare Providers with safety information and patient m... | Class I | Medtronic Neuromodulation |
| Jun 3, 2013 | Medtronic Sutureless Pump Connector Revision Kit, model 8578. Contents: cat... | The Sutureless Connector (SC) Intrathecal Catheter connector has been redesigned to reduce the po... | Class I | Medtronic Neuromodulation |
| Jun 3, 2013 | Medtronic Intrathecal Catheter, model 8731SC. Contents: 38.1-cm spinal segm... | The Sutureless Connector (SC) Intrathecal Catheter connector has been redesigned to reduce the po... | Class I | Medtronic Neuromodulation |
| May 31, 2013 | Cordis a Johnson & Johnson Company, RadialSource Spring Wire Transradial Acce... | Cordis Corporation, Inc and Greatbatch Medical are recalling one lot of the cordis RADIALSOURCE S... | Class II | Greatbatch Medical |
| May 13, 2013 | Digitex Absorbable Polydiaxanone Suture, Size 2-0. Catalog Number / Code of... | Coloplast is conducting a recall on three lots of Digitex Absorbable Polydiaxanone Suture, Size 2... | Class II | Coloplast Manufacturing US, LLC |
| Apr 12, 2013 | Rostorelle L, Polypropylene Mesh, Catalog number 501440, Manufacturer Colopla... | Coloplast is recalling one lot of Restorelle L prosthesis because it is mislabeled. The incorre... | Class II | Coloplast Manufacturing US, LLC |
| Apr 10, 2013 | LATITUDE¿ Patient Management System, Model 6488, Version 7.3. The LATITUDE... | Boston Scientific CRM is conducting a recall on the LATITUDE Patient Management System Model 6488... | Class II | Boston Scientific CRM Corp |
| Mar 27, 2013 | Summit Medical, BL-2006, Myringotomy Lance (Juvenile) Blade, Sterile P, Summi... | Summit Medical has initiated a recall of Myringotomy Lance Blade (Juvenile) because the box cont... | Class II | Summit Medical, Inc. |
| Mar 25, 2013 | KWIK-STIK(TM), Quality control kit for culture media, sold as: KWIK-STIK(... | Some of the KWIK-STIK Catalog #01023P Campylobacter coli, Lot# 1023-05-7, contained an inner labe... | Class III | Microbiologics Inc |
| Mar 15, 2013 | ACIST Medical Systems Inc. The ACIST Angiographic Injection System is inte... | ACIST Medical Systems is issuing a voluntary recall notice for three specific lots of BT2000 Auto... | Class II | Acist Medical Systems |
| Mar 15, 2013 | Vitrea CT Multi-Chamber Cardiac Functional Analysis application on Vitrea ver... | Vital Images has made a decision to perform a field correction to the Vitrea CT Multi-Chamber Car... | Class II | Vital Images, Inc. |
| Mar 15, 2013 | Vitrea¿ CT Brain Perfusion made available in various configurations under the... | Vital Images, Inc. (Vital Images) received one report about potential user confusion when viewing... | Class II | Vital Images, Inc. |
| Mar 13, 2013 | Medtronic Archer 0.035 inch (0.89mm) Super Stiff Guidewire, Models ARCSJ200W... | Medtronic has identified an issue involving specific lot numbers of the Medtronic Archer 0.035 in... | Class II | Medtronic Inc. Cardiac Rhythm Disease Management |
| Mar 13, 2013 | Medtronic Archer Super Stiff Guidewire 0.035 inch (0.89mm), Model ARCSJ200W. ... | Medtronic has identified an issue with a specific lot of the Archer 0.035 inch (0.89mm) Super Sti... | Class II | Medtronic Inc. Cardiac Rhythm Disease Management |
| Mar 1, 2013 | AMS 800¿ Urinary Control System. The AMS 800¿ Urinary Control System is u... | American Medical Systems, Inc. is initiating a recall on two components of the AMS 800¿ Urinary C... | Class II | American Medical Systems, Inc. |
| Mar 1, 2013 | AMS 800¿ Urinary Control System. The AMS 800¿ Urinary Control System is ... | American Medical Systems, Inc. is initiating a recall on two components of the AMS 800¿ Urinary C... | Class II | American Medical Systems, Inc. |
| Mar 1, 2013 | Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generato... | An internal protective fuse can be unintentionally activated while the device is charging its cap... | Class II | Boston Scientific CRM Corp |
| Feb 27, 2013 | Vascular Solutions, Inc., Guardian II and Guardian II NC Hemostasis Valve, us... | Risk that air may be introduced into the device which may lead to an air embolism. | Class I | Vascular Solutions, Inc. |
| Feb 27, 2013 | Medtronic Prostiva RF Therapy Generator. The Prostiva RF system is indicat... | Medtronic has found through device testing that if the optional footswitch is not connected to th... | Class II | Medtronic Neuromodulation |
| Feb 19, 2013 | Medtronic DPL Single Stage Venous Cannula with Metal Tip, used in cardiopul... | Potential for uncharacteristically rough metal edges to occur along the inner diameter of the met... | Class II | Medtronic Inc. Cardiac Rhythm Disease Management |
| Feb 11, 2013 | Microbiologics KWIK-QC SLIDES ( KWIK-QC Acid Fast Stain Slides and KWIK-QC My... | Microbiologics Inc is initiating a voluntary recall on products KWIK-QC Acid Fast Stain Slide, SL... | Class II | Microbiologics Inc |
| Feb 8, 2013 | Medtronic DBS Lead Kit for Deep Brain Stimulation, models 3387, 3387S, 3389, ... | There is a potential for lead damage due to the use of the lead cap provided in DBS and Dystonia ... | Class I | Medtronic Neuromodulation |
| Feb 8, 2013 | Medtronic DBS Therapy for Dystonia Kit, models 3317, 3319, 3337 and 3339. S... | There is a potential for lead damage due to the use of the lead cap provided in DBS and Dystonia ... | Class I | Medtronic Neuromodulation |
| Feb 6, 2013 | Smiths Medical, BCI¿ Remote Alarm Cable (Normally Open & Normally Closed), Re... | In rare instances, the BCI¿ Remote Alarm Cables (BCI¿ Cable) are not transferring alarms when use... | Class I | Smiths Medical ASD, Inc. |
| Feb 5, 2013 | Vitrea Enterprise Suite, Vitrea, VitreaAdvanced, VitreaCore (VitalConnect) an... | Vital Images has found a potential error in measurement generated through the software which aff... | Class II | Vital Images, Inc. |
| Jan 29, 2013 | Vascular Solutions, SuperCross Microcatheter, Sterilized using ethylene oxide... | Vascular Solutions, Inc has discovered a potential problem with a number of lots of Supercross m... | Class II | Vascular Solutions, Inc. |
| Jan 18, 2013 | St. Jude Medical, AGA Medical corporation, AMPLATZER¿ TorqVue¿ FX Delivery Sy... | The distal end of the core wire of the TorqVue FX Delivery System could potentially fracture when... | Class I | St Jude Medical Inc |
| Jan 16, 2013 | 45¿ Angle Driver / Z-H, Greatbatch Medical 10 000 Wahrie Drive, Clarance, NY ... | Greatbatch Medical has initiated a global voluntary recall and market withdrawal of its entire Sm... | Class II | Greatbatch Medical |
| Jan 9, 2013 | Esteem Programmer Model 6001, US and ISA, Model 3001 Dell E54XX, part of the ... | Envoy Medical is conducting a voluntary correction of a limited number of Esteem Programmers, par... | Class II | Envoy Medical Corporation |
| Dec 3, 2012 | Medtronic, DBS Extension Kit for Deep Brain Stimulation, Catalog # 7482, 3708... | Medtronic has identified 140 Restore DBS Extension Kits (model numbers 7482, 37085, and 37086), w... | Class II | Medtronic Neuromodulation |
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.