Browse Device Recalls
1,624 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 1,624 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 1,624 FDA device recalls in MN.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Dec 9, 2022 | CADD Administration Set, List Numbers: a) REF 21-7346-24; b) REF 21-7363-24 | There are two potential issues with CADD Infusion System Infusion Sets: (1) Lack of Delivery or... | Class I | Smiths Medical ASD Inc. |
| Dec 9, 2022 | CADD Administration Set, List Numbers: 1) REF 21-7300-24, 2) REF 21-7301-24... | There are two potential issues with CADD Infusion System Infusion Sets: (1) Lack of Delivery or... | Class I | Smiths Medical ASD Inc. |
| Dec 3, 2022 | Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems ... | Software anomalies, CP App messages: "Too Many Device Found", "Unexpected Device Error Code 1502... | Class II | Medtronic Neuromodulation |
| Dec 3, 2022 | Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems ... | Software anomalies, CP App messages: "Too Many Device Found", "Unexpected Device Error Code 1502... | Class II | Medtronic Neuromodulation |
| Dec 3, 2022 | Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems ... | Software anomalies, CP App messages: "Too Many Device Found", "Unexpected Device Error Code 1502... | Class II | Medtronic Neuromodulation |
| Dec 3, 2022 | Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems ... | Software anomalies, CP App messages: "Too Many Device Found", "Unexpected Device Error Code 1502... | Class II | Medtronic Neuromodulation |
| Dec 3, 2022 | Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems ... | Software anomalies, CP App messages: "Too Many Device Found", "Unexpected Device Error Code 1502... | Class II | Medtronic Neuromodulation |
| Nov 30, 2022 | ActiveAid 922, Shower/Commode Chair | Device manufactured with a component with affects the foldability of the frame, not allowing it t... | Class II | Altimate Medical, Inc. |
| Nov 23, 2022 | COVIDIEN Emprint Ablation Catheter with Thermosphere Technology, Bronchoscopi... | The product is labeled with the incorrect expiration date. | Class II | Covidien, LLC |
| Nov 7, 2022 | R&D CBC-3D Hematology Control: (1) CBC-3D Normal Pack Hematology Control, ... | For one lot of CBC-3D Hematology Control, the Normal Level may exhibit hemolysis or deterioration... | Class III | R & D Systems, Inc. |
| Oct 13, 2022 | EKOS Control Unit 4.0 console, a component of the EKOS Control System 4.0, wh... | Consoles were shipped without an instruction for use (IFU) or with the incorrect IFU. | Class II | Boston Scientific Corporation |
| Oct 10, 2022 | Medfusion Model 4000 Syringe Infusion Pump, with software versions V1.6.0 or ... | Potential for delay in sending Infusion Start Messages to third-party Electronic Health Record sy... | Class II | Smiths Medical ASD Inc. |
| Oct 6, 2022 | 3M Steri-Drape, Small Towel Drape, REF 1000, general surgery drape | During a recent investigation, 3M confirmed the liner on the adhesive component of the affected d... | Class II | 3M Healthcare Business |
| Oct 6, 2022 | 3M Steri-Drape, Small Drape with Adhesive Aperture, REF 1020NS, general surge... | During a recent investigation, 3M confirmed the liner on the adhesive component of the affected d... | Class II | 3M Healthcare Business |
| Oct 6, 2022 | 3M Steri-Drape, Medium Drape with Incise Film and Pouch, REF 1061, general su... | During a recent investigation, 3M confirmed the liner on the adhesive component of the affected d... | Class II | 3M Healthcare Business |
| Oct 6, 2022 | 3M Steri-Drape, Medium Drape with Incise Film and Pouch, REF 1061NS, general ... | During a recent investigation, 3M confirmed the liner on the adhesive component of the affected d... | Class II | 3M Healthcare Business |
| Oct 6, 2022 | 3M Steri-Drape, Medium Drape with Adhesive Aperture, REF 1030, general surger... | During a recent investigation, 3M confirmed the liner on the adhesive component of the affected d... | Class II | 3M Healthcare Business |
| Oct 6, 2022 | 3M Steri-Drape, Small Drape with Incise Film, REF 1021, general surgery drape | During a recent investigation, 3M confirmed the liner on the adhesive component of the affected d... | Class II | 3M Healthcare Business |
| Oct 6, 2022 | 3M Steri-Drape, Small Towel Drape, REF 1000NS, general surgery drape | During a recent investigation, 3M confirmed the liner on the adhesive component of the affected d... | Class II | 3M Healthcare Business |
| Oct 6, 2022 | 3M Steri-Drape, Small Drape with Incise Film, REF 1021NS, general surgery drape | During a recent investigation, 3M confirmed the liner on the adhesive component of the affected d... | Class II | 3M Healthcare Business |
| Oct 6, 2022 | 3M Steri-Drape, Medium Drape with Incise Film, REF 1060NS, general surgery d... | During a recent investigation, 3M confirmed the liner on the adhesive component of the affected d... | Class II | 3M Healthcare Business |
| Oct 6, 2022 | 3M Steri-Drape, Large Towel Drape, REF 1010NS, general surgery drape | During a recent investigation, 3M confirmed the liner on the adhesive component of the affected d... | Class II | 3M Healthcare Business |
| Oct 6, 2022 | 3M Steri-Drape, Medium Drape with Adhesive Aperture, REF 1030NS, general surg... | During a recent investigation, 3M confirmed the liner on the adhesive component of the affected d... | Class II | 3M Healthcare Business |
| Oct 6, 2022 | 3M Steri-Drape, Medium Drape with Wide Adhesive Aperture, REF 1033, general s... | During a recent investigation, 3M confirmed the liner on the adhesive component of the affected d... | Class II | 3M Healthcare Business |
| Oct 6, 2022 | 3M Steri-Drape, Large Towel Drape, REF 1010NSD, general surgery drape | During a recent investigation, 3M confirmed the liner on the adhesive component of the affected d... | Class II | 3M Healthcare Business |
| Oct 6, 2022 | 3M Steri-Drape, Urological Drape, REF 1071, general surgery (urology) drape | During a recent investigation, 3M confirmed the liner on the adhesive component of the affected d... | Class II | 3M Healthcare Business |
| Oct 6, 2022 | 3M Steri-Drape, Small Towel Drape, REF 1000NSD, general surgery drape | During a recent investigation, 3M confirmed the liner on the adhesive component of the affected d... | Class II | 3M Healthcare Business |
| Oct 6, 2022 | 3M Steri-Drape, Medium Drape with Incise Film, REF 1060, general surgery drape | During a recent investigation, 3M confirmed the liner on the adhesive component of the affected d... | Class II | 3M Healthcare Business |
| Oct 6, 2022 | 3M Steri-Drape, Large Towel Drape, REF 1010, general surgery drape | During a recent investigation, 3M confirmed the liner on the adhesive component of the affected d... | Class II | 3M Healthcare Business |
| Oct 6, 2022 | 3M Steri-Drape, Small Drape with Adhesive Aperture, REF 1020, general surgery... | During a recent investigation, 3M confirmed the liner on the adhesive component of the affected d... | Class II | 3M Healthcare Business |
| Oct 4, 2022 | EasyStand Bantam, with the following sizes. a. Small; b. Extra Small. ... | Some EasyStand Bantam Small and Extra Small standers with the non-supine option may have been man... | Class II | Altimate Medical, Inc. |
| Sep 30, 2022 | EMBLEM MRI S-ICD, Subcutaneous Implantable Defibrillator, Model A219, sterile. | There is an incorrect manufacturing date/timestamp within the software which causes an inaccurate... | Class II | Boston Scientific Corporation |
| Sep 30, 2022 | EMBLEM S-ICD, Subcutaneous Implantable Defibrillators, Model A209, sterile. | There is an incorrect manufacturing date/timestamp within the software which causes an inaccurate... | Class II | Boston Scientific Corporation |
| Aug 12, 2022 | COVID Test Kit Nonsterile | Kit incorrectly labeled for use with COVID testing and should not be used with any SARS-Co-V2 dev... | Class II | American Contract Systems, Inc. |
| Aug 9, 2022 | Boston Scientific Guider Softip XF, 40 XF, 8F, Guide Catheter, REF H965100440 | The impacted products were distributed with an MPXF tip curve shape instead of the 40XF tip curve... | Class II | Boston Scientific Corporation |
| Jul 27, 2022 | Helix Elite Inactivated Standard, labeled as: a. Inactivated SARS-CoV-2 B... | Product not registered for use in the UK | Class III | Microbiologics Inc |
| Jul 26, 2022 | Vanta Clinician Programmer Application, Model A71200. For programming of the... | Potential for Vanta Clinician Programmer Application (CP App) A71200 v2.0.2455 to display an Unex... | Class II | Medtronic Neuromodulation |
| Jul 26, 2022 | Vanta Clinician Programmer Application, Model A71200. For programming of the... | Potential communication issue in which the Vanta Clinician Programmer Application (CP App) A71200... | Class II | Medtronic Neuromodulation |
| Jul 14, 2022 | EverFlex Self-Expanding Peripheral Stent with Entrust Delivery System | Update to IFU provides a manual deployment workaround method to help mitigate potential harms rel... | Class II | Medtronic Inc. |
| Jul 7, 2022 | The Programmer/Recorder/Monitor (PRM) is intended to be used as part of the Z... | There is potential for unanticipated software anomalies to occur when using the Model 2868 Applic... | Class II | Boston Scientific Corporation |
| Jul 7, 2022 | The PRM is intended to be used as part of the ZOOM LATITUDE Programming Syste... | There is potential for unanticipated software anomalies to occur when using the Model 2868 Applic... | Class II | Boston Scientific Corporation |
| Jul 7, 2022 | The PRM is intended to be used as part of the ZOOM LATITUDE Programming Syste... | There is potential for unanticipated software anomalies to occur when using the Model 2868 Applic... | Class II | Boston Scientific Corporation |
| Jun 29, 2022 | SX-One MicroKnife | Potential of dull blade | Class II | SONEX HEALTH LLC |
| Jun 24, 2022 | Medline Sprinter OTW, Model/Catalog Number SPR2512W; The Sprinter Over-the-Wi... | Luer has balloon diameter printed as "2.25mmx12mm" instead of the correct diameter, "2.5mmx12mm" ... | Class II | Medtronic Inc |
| Jun 22, 2022 | Cobalt Implantable Cardioverter Defibrillators with Cardiac Resynchronization... | There is the potential for reduced shock energy (~79% of programmed energy) during high-voltage (... | Class I | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Jun 22, 2022 | Cobalt Implantable Cardioverter Defibrillators: a. Cobalt VR ICD, Model Numbe... | There is the potential for reduced shock energy (~79% of programmed energy) during high-voltage (... | Class I | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Jun 22, 2022 | Crome Implantable Cardioverter Defibrillators with Cardiac Resynchronization ... | There is the potential for reduced shock energy (~79% of programmed energy) during high-voltage (... | Class I | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Jun 22, 2022 | Cobalt Implantable Cardioverter Defibrillators with Cardiac Resynchronization... | There is the potential for reduced shock energy (~79% of programmed energy) during high-voltage (... | Class I | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Jun 22, 2022 | Cobalt Implantable Cardioverter Defibrillators: a. Cobalt XT VR ICD, Model Nu... | There is the potential for reduced shock energy (~79% of programmed energy) during high-voltage (... | Class I | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Jun 22, 2022 | Crome Implantable Cardioverter Defibrillators: a. Crome VR ICD, Model Numbers... | There is the potential for reduced shock energy (~79% of programmed energy) during high-voltage (... | Class I | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
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.