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.

Clear
DateProductReasonClassFirm
Nov 19, 2012 Medtronic Intersept Custom Tubing Pack with or without coating ( Carmeda BioA... Medtronic is initiating an Urgent Medical Device Customer Notification. We have confirmed that c... Class II Medtronic Inc. Cardiac Rhythm Disease Management
Nov 12, 2012 Biosense Webster MobiCath Bi-Directional Guiding Sheath. Small Curve catalog... Greatbatch Medical observed some anomalies of the inner lumen of the MobiCath Bi-Directional Guid... Class II Greatbatch Medical
Nov 9, 2012 Medtronic SynchroMed II, Model 8637, (The SynchroMed¿ II Pump is supplied in ... Medtronic notified Healthcare Professionals of the impact of unapproved drugs on the performance ... Class I Medtronic Neuromodulation
Nov 9, 2012 SynchroMed EL, models 8626-10, 8626L-10, 8626-18, 8626L-18, 8627-10, 8627L-10... Medtronic notified Healthcare Professionals of the impact of unapproved drugs on the performance ... Class I Medtronic Neuromodulation
Nov 5, 2012 Arobella Medical 6mm Qurette used with the Arobella Medical AR1000 Wound Ther... This recall has been initiated because the Arobella Medical 6mm Qurette Q07 Lot Numbers 0001 and ... Class II Arobella Medical, LLC
Oct 19, 2012 AMS AdVance" Male Sling System 720088-01 AMS AdVance" Male Sling System (US)... American Medical Systems¿ (AMS) is issuing a voluntary recall on a number of lots of the AdVance¿... Class II American Medical Systems, Inc.
Sep 24, 2012 Biosense Webster MobiCath Bi-Directional Guiding Sheath. Small Curve catalog... We are notifying you of a potential interaction between therapeutic catheters and MobiCath Bi-Dir... Class II Greatbatch Medical
Sep 13, 2012 3M Steri-Vac Gas Sterilizer/Aerator models 5XL and 8XL. 3M Steri-Vac Gas S... 3M determined that the electrical grounding mechanism for the Steri-Vac 5XL and 8XL gas Sterilize... Class II 3M Company - Health Care Business
Sep 6, 2012 Boston Scientific, Z Flex 270, Steerable Sheath, Sterile EO, Rx only, Distri... During the investigation of four returned Z Flex 270 Steerable Sheaths that were used with cardia... Class II Greatbatch Medical
Aug 30, 2012 Guardian II Hemostasis Valve, Model 8210 and Guardian II NC Hemostasis Valve,... Vascular Solutions, Inc., became aware of a potential problem involving pouches missing a seal fr... Class II Vascular Solutions, Inc.
Aug 13, 2012 Software for Vitrea, Vitrea fX, and Vitrea Enterprise Suite (VES): VPMC... Vital Images has found two potential errors in calcium score values in restored snapshots of stud... Class II Vital Images, Inc.
Jul 20, 2012 Visual-ICE¿ Cryoablation System, Model FPRCH 6000 Product Usage: The Galil... Galil Medical is recalling a number of Visual Ice Cryoablation Systems because the gas regulators... Class II Galil Medical, Inc.
Jun 27, 2012 Mar Cor Purification CWP Reverse Osmosis System. Models 101, 102, 104, and 106. There exists a potential situation with the crimp connection at the pump head assembly. The pote... Class II Mar Cor Purification
Jun 26, 2012 BridgePoint Medical, Stingray Catheter, REF M - 1000, Sterilized with Ethyle... BridgePoint Medical Inc. is voluntarily recalling Stingray Catheter, Model M1000 lots BP20121440... Class II Bridgepoint Medical
Jun 19, 2012 CareFusion EnVe Ventilator Designed for use on patients who require respir... CareFusion identified that the EnVe Ventilator may not hold the set Positive End Expiratory Press... Class I CareFusion 203, Inc.
Jun 18, 2012 superDimension Systems AAS00016-xx with Software Version 4.0-4.9. Indicate... superDimension, Inc., is conducting a recall of certain superDimension Systems operating Software... Class II superDimension, Inc
Jun 18, 2012 CSI Stealth 360-degree Orbital Atherectomy Device (OAD), Part Number 70056-11... CSI has initiated a recall on specific lot numbers of Stealth 360-degree Orbital Atherectomy devi... Class II Cardiovascular Systems, Inc.
May 29, 2012 Microbiologics 217 Osseo Avenue North, St. Cloud, MN 56303, Gram Stain Contr... Microbiologics is recalling a number of lots of KWIK-QC Gram Stain Slides. This product gram neg... Class II Microbiologics Inc
Mar 28, 2012 Fast-Cath Transseptal Guiding Introducer, 90, 8F, REF 406586, Length 60 cm, S... St. Jude Medical is recalling a single batch of Fast Cath Transseptal Guiding Introducers which w... Class III St Jude Medical Inc
Feb 24, 2012 Lithium Thionyl non-rechargeable disposable battery pack P/N 350-0294-01 used... Braemar has recently became aware of a battery related incident that occurred with EWT battery pa... Class II BRAEMAR, INC.
Feb 14, 2012 Smiths Medical, Medfusion¿ Syringe Infusion Pump, Model 4000, Software Versio... Smiths Medical has identified a software anomaly in the Medfusion 4000 Syringe Infusion Pump that... Class I Smiths Medical ASD, Inc.
Feb 9, 2012 Reusable, Self-Adhering TENS/NMES/FES electrodes Single Patient Use Only. ... Covidien is conducting a voluntary recall regarding specific lots of TENS electrodes because it w... Class II Covidien LLC dba Uni-Patch
Feb 9, 2012 Reusable, non-sterile, self-adhering electrodes for use with TENS/NMES, . Ma... Covidien is conducting a voluntary recall regarding specific lots of TENS electrodes because it w... Class II Covidien LLC dba Uni-Patch
Feb 9, 2012 Performa reusable and self-adhering TENS/NMES/FES stimulating electrodes, ... Covidien is conducting a voluntary recall regarding specific lots of TENS electrodes because it w... Class II Covidien LLC dba Uni-Patch
Feb 9, 2012 Empi STIMC RE Self Adhesive electrodes. For use on TENS, NMES, FES. a DJO b... Covidien is conducting a voluntary recall regarding specific lots of TENS electrodes because it w... Class II Covidien LLC dba Uni-Patch
May 2, 2011 Lithium Thionyl non-rechargeable disposable battery pack P/N 350-0294-00 used... Braemar Inc., became aware of a battery related incident that occurred with an Able battery pack... Class II BRAEMAR, INC.
May 14, 2010 Medfusion Model 3500 Syringe Pump, Model #3500-415 and 3500-500. Intended ... An issue with the plunger rod seal was identified where the seal had the potential to migrate ins... Class II Smiths Medical ASD, 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.