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 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... |
| Jun 14, 2022 | Quantikine IVD Erythropoietin Human Serum Controls for use as quantitative co... | The Instructions for Use (IFU, Part Number 750095) provided with the affected lots by the firm co... | Class III | R & D Systems, Inc. |
| Jun 9, 2022 | Abbott TactiCath Sensor Enabled, Contact Force Ablation Catheter, 8F 115cm FJ... | When connected to the EnSite Precision Navigation System, an affected TactiCath Contact Force Abl... | Class II | Abbott |
| May 27, 2022 | LEAD 3387S-40 STIMLOC DBS, Model Number 3387S-40. Electrical implantable device. | There are a small number of units of the DBS Lead with StimLoc kit (3387S-40) due to a discrepanc... | Class II | Medtronic Neuromodulation |
| May 25, 2022 | EkoSonic Kit 135cm, 12cm TZ The EkoSonic Endovascular Device is packaged a... | Product may be mislabeled. | Class II | Boston Scientific Corporation |
| May 25, 2022 | EkoSonic Kit 106cm, 12cm TZ The EkoSonic Endovascular Device is packaged a... | Product may be mislabeled. | Class II | Boston Scientific Corporation |
| May 6, 2022 | KWIK-STIK" plus: Clostridium perfringens | Labeling error. | Class III | Microbiologics Inc |
| May 5, 2022 | HeartWare Battery, Model #1650DE, a component of the HeartWare Ventricular As... | Batteries for the HVAD system have a weld defect affecting internal components within the HVAD ba... | Class I | Medtronic Inc |
| May 3, 2022 | Ratcheting Screwdriver Handle, provided in the Aequalis Perform Reversed kit | The device is unable to meet sterilization requirements when sterilized per instructions in an Ae... | Class II | Tornier, Inc |
| Apr 28, 2022 | FIRMap" Catheter, 60mm Basket | Incorrect product labeling. | Class II | Abbott |
| Apr 20, 2022 | The C304-HIS device features a guide wire to access the vein, a valve to redu... | The firm's internal processes identified that certain lots may have an improperly sealed barrier ... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Apr 20, 2022 | Cardioblate" Gemini"-s Irrigated RF Surgical Ablation System; The device is p... | Firm detected an increase in complaints related to fractured jaw tips of the Cardioblate Gemini-s. | Class II | Medtronic Perfusion Systems |
| Apr 18, 2022 | Medfusion Syringe Pump Model: Model 4000-0100-50, Model 4000-0101-249, Model... | Multiple issues with the potential for interruption of therapy or over-infusion: 1. Primary Audi... | Class I | Smiths Medical ASD Inc. |
| Apr 18, 2022 | Medfusion Syringe Pump Models: 3500, 3500-0600-00, 3500-0600-01, 3500-0600-2... | Multiple issues with the potential for interruption of therapy or over-infusion: 1. Primary Audi... | Class I | Smiths Medical ASD Inc. |
| Apr 14, 2022 | HeartWare HVAD Pump Implant Kit, a) Model Number 1104JP, b) Model Number MCS1... | The pump may have a welding defect that can lead the pump to malfunction. The issue is under inve... | Class I | Medtronic Inc |
| Apr 12, 2022 | Cobalt Models loaded with CareLink SmartSync Device Manager application softw... | Telemetry error that may occur with Medtronic Cobalt and Crome implantable cardioverter defibrill... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Apr 12, 2022 | Crome Models loaded with CareLink SmartSync Device Manager application softwa... | Telemetry error that may occur with Medtronic Cobalt and Crome implantable cardioverter defibrill... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Apr 8, 2022 | TMJ Arthroscopy Drape, 85''x 96'' | Latex content in product was labeled incorrectly as latex free. | Class II | Microtek Medical Inc. |
| Mar 30, 2022 | Instructions for Use, Patient Manuals, and Emergency Responder Guides for Hea... | Errors and inconsistencies that were identified in the Instruction for Use (IFU), Emergency Respo... | Class II | Medtronic Inc |
| Mar 30, 2022 | Percept BrainSense Implantable Neurostimulator (INS), Model B35200 | The Implantable Neurostimulator (INS) cannot communicate with the clinical programmer and/or the ... | Class II | Medtronic Neuromodulation |
| Mar 30, 2022 | Percept PC BrainSense Implantable Neurostimulator (INS) Model B35200 | The Implantable Neurostimulator (INS) cannot communicate with the clinical programmer and/or the ... | Class II | Medtronic Neuromodulation |
| Mar 30, 2022 | Vanta INS Implantable Neurostimulator. Medtronic Model 977006 Vanta with Adap... | The Implantable Neurostimulator Model may be susceptible to not communicating with the clinical p... | Class II | Medtronic Neuromodulation |
| Mar 24, 2022 | Abbott SE TactiCath Sensor Enabled Contact Force Ablation Catheter, Bi-D, Cur... | Devices were manufactured with a "First Use Date" preprogrammed in the EEPROM which disables the ... | Class II | Abbott |
| Mar 24, 2022 | Abbott SE TactiCath Sensor Enabled Contact Force Ablation Catheter, Bi-D, Cur... | Devices were manufactured with a "First Use Date" preprogrammed in the EEPROM which disables the ... | Class II | Abbott |
| Mar 24, 2022 | Inactivated macrolide and quinolone-resistant Mycoplasma genitalium | QC process was not adequate for the specification range. | Class II | Microbiologics Inc |
| Mar 22, 2022 | Inactivated macrolide-resistant Mycoplasma genitalium | The QC process was not adequate for the specification range. | Class II | Microbiologics Inc |
| Mar 21, 2022 | WAVES WCM Kidney Cassette Module | There is a potential for the WCM cassette pump head leaking solution. | Class II | Waters Medical Systems LLC |
| Mar 14, 2022 | Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Contr... | HotDog Temperature Management Controllers Models WC71, WC77, and Temperature Management Controlle... | Class II | Augustine Temperature Management, LLC |
| Mar 14, 2022 | Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Contr... | HotDog Temperature Management Controllers Models WC71, WC77, and Temperature Management Controlle... | Class II | Augustine Temperature Management, LLC |
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.