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.

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DateProductReasonClassFirm
Feb 20, 2024 Obsidio Conformable Embolic, Material Numbers (UPN): a) M0013972001010, b) M0... An investigation determined that delivery of the Obsidio embolic using the aliquot technique for ... Class I Boston Scientific Corporation
Feb 16, 2024 Abre Venous Self-expanding Stent System, Product Numbers: a) AB9U14080090;... There is a potential for sterile package breach. Class II Medtronic Inc.
Feb 15, 2024 Augustine Surgical Inc. HotDog Return Electrode accessory connector cables, M... Users were experiencing the following error message (M-0B-125) stated Check Neutral Electrode Co... Class II Augustine Temperature Management, LLC
Feb 15, 2024 Augustine Surgical Inc. HotDog Return Electrode accessory connector cables, M... Users were experiencing the following error message (M-0B-125) stated Check Neutral Electrode Co... Class II Augustine Temperature Management, LLC
Feb 12, 2024 Boston Scientific POLARSHEATH Steerable Sheath 12F, REF M004CRBS3050 Boston Scientific has identified a tooling error in manufacturing which may have caused delaminat... Class I Boston Scientific Corporation
Feb 8, 2024 Access Total T4, REF 33800, IVD, thyroxine reagent assay. Four lots of Access Total T4 reagent lots demonstrated imprecision outside of the 10% specificati... Class II Beckman Coulter, Inc.
Feb 7, 2024 Access Substrate, REF 81906, For use with the Access Immunoassay Systems On 07 February 2024 Beckman Coulter made the decision to conduct a field action on Access Substra... Class II Beckman Coulter, Inc.
Feb 7, 2024 smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP,... When a paraPAC plus ventilator is switched to the operating mode of VENTILATE, the ventilator may... Class I Smiths Medical ASD Inc.
Feb 7, 2024 Medtronic DLP Vessel Cannula, Model Number REF 30000 Medtronic is writing to inform you of incorrect labeling for three manufactured lots of the DLP V... Class II Medtronic Perfusion Systems
Feb 7, 2024 smiths medical Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, RE... When a paraPAC plus ventilator is switched to the operating mode of VENTILATE, the ventilator may... Class I Smiths Medical ASD Inc.
Jan 12, 2024 3M Specialty Blade Assembly, REF 9660,70-2011-8491-1, 7100213026, used with u... 3M has added the following cautionary statement regarding the use of the product: "Caution - T... Class II 3M Company - Health Care Business
Jan 12, 2024 3M Specialty Blade Assembly, REF 9660,70-2011-8462-2, 7100213114, used with u... 3M has added the following cautionary statement regarding the use of the product: "Caution - T... Class II 3M Company - Health Care Business
Jan 8, 2024 Microbiologics Enteric Pathogens Control Panel (Inactivated Pellet), REF 8184. The negative control was contaminated with one of the positive control pathogens (Norovirus). Th... Class II Microbiologics Inc
Jan 3, 2024 Beckman Coulter DxI 9000 Access Immunoassay Analyzer, catalog number C11137; ... A software error caused an increase in tray gripper motion errors that causes intermittent hard s... Class II Beckman Coulter, Inc.
Jan 3, 2024 Stryker Tornier Perform Reversed Glenoid Press-Fit Short Post Ti6AI4V, REF DW... The incorrect device is contained in the labeled package. Class II Tornier, Inc
Dec 19, 2023 Model A710 Intellis Clinician Programmer Application, version 2.0.97 Medtronic has discovered an instance in which the Intellis A710 Clinician Programmer Application ... Class II Medtronic Neuromodulation
Dec 19, 2023 Smiths Medical Model 3010 Syringe pumps: a. Protege Model 3010, b. Medf... Medfusion Model 4000, 3500, and 3010 pumps manufactured or serviced with Barrel Clamp Guide (Part... Class II Smiths Medical ASD Inc.
Dec 19, 2023 Smiths Medical Medfusion Model 3500 Syringe pumps, Item Numbers: a) 3500 ... Medfusion Model 4000, 3500, and 3010 pumps manufactured or serviced with Barrel Clamp Guide (Part... Class II Smiths Medical ASD Inc.
Dec 19, 2023 Smiths Medical Medfusion Guide Barrel Clamp, Item number G6000716 Medfusion Model 4000, 3500, and 3010 pumps manufactured or serviced with Barrel Clamp Guide (Part... Class II Smiths Medical ASD Inc.
Dec 19, 2023 smiths medical Medfusion Model 4000 syringe pump Medfusion Model 4000 syringe infusion pumps, with the following software versions, may have the f... Class I Smiths Medical ASD Inc.
Dec 19, 2023 Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-01... Medfusion Model 4000, 3500, and 3010 pumps manufactured or serviced with Barrel Clamp Guide (Part... Class II Smiths Medical ASD Inc.
Dec 19, 2023 smiths medical Medfusion Model 3500 Syringe pump Medfusion syringe pumps, with software versions before v6.0.0, may have the following issues:1. D... Class I Smiths Medical ASD Inc.
Dec 18, 2023 TactiFlex Ablation Sensor Enabled Ablation Catheter, Models A-TFSE-FJ, 7.5 F ... When the catheters are used with the EnSiteX EP System, the system does not correctly recognize t... Class II St. Jude Medical, Atrial Fibrillation Division,...
Dec 13, 2023 DiaSorin LIAISON HSV-2 Type Specific IgG, REF 310620 DiaSorin has identified that lots 136344, 136344A, 136344B, 136344C, 136520, 136520A, 136520B, 13... Class II Diasorin Inc.
Dec 7, 2023 Cobalt XT DR MRI SureScan Implantable Cardioverter Defibrillator, product num... During internal review of Polaris battery assembly data from the HiPot operation, a test systems ... Class II Medtronic Inc.
Nov 30, 2023 Boston Scientific Model 3120 ZOOM LATITUDE Programmer/Recorder/Monitor (PRM) ... The software application on the Programmer/Recorder/Monitor (PRM) for Implantable Pulse Generator... Class II Boston Scientific Corporation
Nov 21, 2023 DxI 9000 Access Immunoassay Analyzer running software version 1.16 or prior, There are potential performance issues found in the DxI 9000 Access Immunoassay Analyzer, includi... Class II Beckman Coulter, Inc.
Nov 21, 2023 Access Ultrasensitive Insulin only used on the DxI 9000 Access Immunoassay An... There is an issue with the Access Ultrasensitive Insulin assay protocol file (APF) for use with t... Class II Beckman Coulter, Inc.
Nov 20, 2023 Protege GPS Self-Expanding Peripheral Stent System, product number SERB65-09-... Seal defects could compromise the ability of the product packaging to maintain sterility. Class II Medtronic Inc.
Nov 13, 2023 Medtronic SynchroMed II, Model 8637-40, Programmable pump Medtronic recently identified that if the SynchroMed II pump switches into telemetry mode due to ... Class II Medtronic Neuromodulation
Nov 13, 2023 Medtronic SynchroMed II, Model 8637-20, Programmable pump Medtronic recently identified that if the SynchroMed II pump switches into telemetry mode due to ... Class II Medtronic Neuromodulation
Nov 3, 2023 ICM LNQ22 LINQ II, Model LNQ22; Insertable Cardiac Monitor It may create the potential for amplified noise and/or overall signal reduction of the ICM, which... Class II Medtronic Inc.
Oct 19, 2023 Model 97745 Controller used with Models 97715 and 97716 Intellis Neurostimula... Units distributed in Korea and Turkey that did not have the correct firmware installed to support... Class II Medtronic Neuromodulation
Oct 18, 2023 LYFO-DISK, P. venetum, Catalog number 0794L A complaint investigation showed that the bulk pellets (lot 794-142) were contaminated with Asper... Class II Microbiologics Inc
Oct 18, 2023 KWIKSTIK, P. venetum, Catalog numbers: a) 0794P (2-pack), b) 0794K (6-pack) A complaint investigation showed that the bulk pellets (lot 794-142) were contaminated with Asper... Class II Microbiologics Inc
Oct 12, 2023 Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MUS01... The Mo.Ma Ultra device manifold is labelled with 2 stickers, an inferior and superior sticker, on... Class II Medtronic Inc
Oct 12, 2023 Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MOM01... The Mo.Ma Ultra device manifold is labelled with 2 stickers, an inferior and superior sticker, on... Class II Medtronic Inc
Oct 12, 2023 Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MOM01... The Mo.Ma Ultra device manifold is labelled with 2 stickers, an inferior and superior sticker, on... Class II Medtronic Inc
Sep 28, 2023 Abbott NT2000iX Radiofrequency (RF) generator, REF RFG-NT-2000, lesioning gen... Certain NT2000iX RF generators were serviced using a tool that was subsequently found to be out o... Class II Abbott
Sep 15, 2023 stryker Tornier Perform Reversed Augmented Glenoid Lateralized Baseplate, 25m... One lot of Tournier Perform Reversed Lateralized Baseplates were found to have been manufactured ... Class II Tornier, Inc
Sep 12, 2023 DxI 9000 Access Immunoassay Analyzer, REF C11137, Sofware Versions 1.15 and b... The firm has investigated and confirmed that when DxI 9000 is connected to Laboratory Information... Class II Beckman Coulter, Inc.
Sep 6, 2023 Portex Pro-Vent Arterial Blood Sampling Kit with Dry Lithium Heparin for Gase... The complaint involved the absence of a component called "ASM Filter-Pro ABG SYR CAP" from the pa... Class II Smiths Medical ASD Inc.
Aug 22, 2023 3M Attest Super Rapid 5 Steam-Plus Steam Challenge Pack, REF 41482V; designed... Specific lots of 3M Attest Super Rapid Readout Biological Indicators (1492V), 3M Attest Super Rap... Class II 3M Company - Health Care Business
Aug 22, 2023 3M Attest Super Rapid Readout Steam Challenge Pack, REF 1496V; designed to qu... Specific lots of 3M Attest Super Rapid Readout Biological Indicators (1492V), 3M Attest Super Rap... Class II 3M Company - Health Care Business
Aug 22, 2023 3M Attest Super Rapid 5 Steam-Plus Steam Challenge Pack, REF 41482VF; designe... Specific lots of 3M Attest Super Rapid Readout Biological Indicators (1492V), 3M Attest Super Rap... Class II 3M Company - Health Care Business
Aug 22, 2023 Smiths Medical Portex Bivona Pediatric Tracheostomy Tube, Cuffless, Model 60P... The unit box is labeled with an incorrect expiration date (the manufacturing date of 3/17/2021) b... Class II Smiths Medical ASD Inc.
Aug 22, 2023 3M Attest Super Rapid Readout Biological Indicator, REF 1492V; used to qualif... Specific lots of 3M Attest Super Rapid Readout Biological Indicators (1492V), 3M Attest Super Rap... Class II 3M Company - Health Care Business
Aug 16, 2023 Medfusion PLUNGER FLOAT PLATE, Component Number G6000069, used on infusion pump A force sensor in the occlusion detector may drift out of calibration leading to increased occlus... Class II Smiths Medical ASD Inc.
Aug 16, 2023 Medfusion ASSEMBLY PLUNGER CASE LEFT 1/EA, Component Number G6001587, used on... A force sensor in the occlusion detector may drift out of calibration leading to increased occlus... Class II Smiths Medical ASD Inc.
Aug 16, 2023 Medfusion Syringe Pump, Model 3500VX-500, v3, v4, v5, and v6 A force sensor in the occlusion detector may drift out of calibration leading to increased occlus... 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.