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 |
|---|---|---|---|---|
| Oct 11, 2013 | Safire Duo Ablation Catheter MediGuide Enabled, REF A700240 and A700238, Rx o... | St. Jude Medical Cardiovascular and Ablation Technologies Division is performing a voluntary noti... | Class II | St. Jude Medical |
| Oct 11, 2013 | US Safire Duo Ablation Catheter MediGuide Enabled, REF A700240 and Cool Path ... | St. Jude Medical Cardiovascular and Ablation Technologies Division is performing a voluntary noti... | Class II | St. Jude Medical |
| Sep 30, 2013 | Medtronic Activa PC, model 37601, and Activa RC, model 37612, Activa SC, mode... | Medtronic notified customers regarding Loss of Stimulation of specific Implantable Neuro-Stimulat... | Class II | Medtronic Neuromodulation |
| Sep 30, 2013 | Medtronic Activa PC, model 37601, and Activa RC, model 37612, Multi-program R... | Medtronic notified customers regarding over stimulation or stimulation in the wrong area related ... | Class II | Medtronic Neuromodulation |
| Sep 30, 2013 | Medtronic RestoreUltra, model 37712, and RestoreSensor, model 37714, Multi-pr... | Medtronic notified customers regarding Loss of Stimulation of specific Implantable Neuro-Stimulat... | Class II | Medtronic Neuromodulation |
| Sep 30, 2013 | Medtronic RestoreUltra, model 37712, and RestoreSensor, model 37714, Multi-pr... | Medtronic notified customers regarding over stimulation or stimulation in the wrong area related ... | Class II | Medtronic Neuromodulation |
| Sep 10, 2013 | Smiths Medical, Deltec: REF 21-8011-24 Port-A-Cath Dual-Lumen. Titanium Ve... | Smiths Medical is conducting a voluntary recall of PORT-A-CATH¿ and PORT-A-CATH¿ II Implantable V... | Class II | Smiths Medical ASD, Inc. |
| Sep 10, 2013 | Smith Medical, Deltec, REF 21-2386-24, 11 Fr Introducer Set with Peel-Away S... | Smiths Medical is conducting a voluntary recall of PORT-A-CATH¿ and PORT-A-CATH¿ II Implantable V... | Class II | Smiths Medical ASD, Inc. |
| Aug 29, 2013 | Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillat... | The performance of a low voltage capacitor in a subset of COGNIS CRT-Ds and TELIGEN ICDs manufact... | Class II | Boston Scientific CRM Corp |
| Aug 29, 2013 | Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E11... | The performance of a low voltage capacitor in a subset of COGNIS CRT-Ds and TELIGEN ICDs manufact... | Class II | Boston Scientific CRM Corp |
| Aug 13, 2013 | AEQUALIS Reversed II or AEQUALIS Reversed Fracture Impactor. These products ... | Following the identification of the disassociation of an impactor tip during surgery, Tornier is ... | Class II | Tornier, Inc |
| Aug 5, 2013 | 3M Scotchcast, Wet or Dry Cast Padding, Catalog Numbers WDP2, WDP3, WDP4, and... | 3M is conducting a voluntary product recall of selected lots of 3M" Scotchcast" Wet or Dry Cast P... | Class II | 3M Company - Health Care Business |
| Aug 5, 2013 | 3M ESPE Unitek Primary Stainless Steel Crowns (First Primary UL4), Product co... | 3M ESPE is recalling Unitek Primary Stainless Steel Crowns (First Primary UL4) because these prod... | Class II | 3M Company/3m Espe Dental Products |
| Jul 31, 2013 | Boston Scientific, FlextomeTM Cutting BalloonTM, Sterilized using irradiatio... | Boston Scientific is initiating a recall removal of the 4.0mm x 15mm size of Small Peripheral Cut... | Class II | Boston Scientific Corporation |
| Jul 31, 2013 | Boston Scientific, Small Peripheral Cutting BalloonTM, Sterilized using irrad... | Boston Scientific is initiating a recall removal of the 4.0mm x 15mm size of Small Peripheral Cut... | Class II | Boston Scientific Corporation |
| Jul 24, 2013 | GYRUS ACMI, REF 3740, Everest BiCOAG Bipolar Dissecting Forceps 5mm/45 cm, St... | On April 29, 2013 Olympus Surgical Technologies America R&D received results from an accelerated... | Class II | Gyrus Medical, Inc |
| Jul 24, 2013 | Nestle Nutrition, Compat, Enteral Feeding Tube, sterile, 8 French (REF 083104... | Nestle HealthCare Nutrition, Inc. is initiating a recall on some of Compat NG Tubes because they... | Class II | Nestle HealthCare Nutrition |
| Jul 19, 2013 | Blue Belt Technologies, Inc. Monitor Drape REF: PFSD-V0001, Rx only, Sterile... | Blue Belt Technologies is recalling sterile Monitor Drapes used with their Navio PFS system durin... | Class II | Blue Belt Technologies MN |
| Jul 17, 2013 | Medtronic Custom Perfusion System with Trillium BioSurface (a polymer contain... | 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. 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. |
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.