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.

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DateProductReasonClassFirm
May 13, 2026 Medtronic 2x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64002; Sti... A limited number of Pocket Adaptor Kits, Model 64001 and 64002, are labeled with incorrect Use-By... Class II Medtronic Neuromodulation
May 13, 2026 Medtronic 1x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64001; Sti... A limited number of Pocket Adaptor Kits, Model 64001 and 64002, are labeled with incorrect Use-By... Class II Medtronic Neuromodulation
Apr 21, 2026 Medtronic GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 15FR, Mode... Certain lots of product have the potential for a sterile barrier breach. Class II Medtronic Perfusion Systems
Apr 21, 2026 Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model... Certain lots of product have the potential for a sterile barrier breach. Class II Medtronic Perfusion Systems
Apr 21, 2026 Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model... Certain lots of product have the potential for a sterile barrier breach. Class II Medtronic Perfusion Systems
Apr 21, 2026 Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model... Certain lots of product have the potential for a sterile barrier breach. Class II Medtronic Perfusion Systems
Apr 21, 2026 Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model... Certain lots of product have the potential for a sterile barrier breach. Class II Medtronic Perfusion Systems
Apr 21, 2026 Medtronic GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 13FR, Mo... Certain lots of product have the potential for a sterile barrier breach. Class II Medtronic Perfusion Systems
Apr 21, 2026 Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model... Certain lots of product have the potential for a sterile barrier breach. Class II Medtronic Perfusion Systems
Apr 21, 2026 Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model... Certain lots of product have the potential for a sterile barrier breach. Class II Medtronic Perfusion Systems
Apr 21, 2026 Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model... Certain lots of product have the potential for a sterile barrier breach. Class II Medtronic Perfusion Systems
Apr 8, 2026 Medtronic SynchroMed Flex Infusion Mode - A810 Clinician Programmer Software ... Software issue: When programming the SynchroMed Pump with the A810 CP App in Flex Infusion Mode,... Class II Medtronic Neuromodulation
Mar 30, 2026 LUX-Dx II Plus, Arrythmia detector and alarm, Model M312, with SERVER SW LATI... For some patients upgraded from a LUX-Dx M301 device to a new Model M302 or M312, the new ICM dev... Class II Boston Scientific Corporation
Mar 30, 2026 LUX-DX II, Arrythmia detector and alarm, Model M302, with SERVER SW LATITUDE ... For some patients upgraded from a LUX-Dx M301 device to a new Model M302 or M312, the new ICM dev... Class II Boston Scientific Corporation
Mar 19, 2026 Boston Scientific Pacemaker, Implantable Pulse Generator, Pacemaker (non- Car... Updated software, Brady software maintenance release 6 (SMR6), is now available for the ACCOLADE"... Class I Boston Scientific Corporation
Mar 19, 2026 Boston Scientific Cardiac Resynchronization Therapy (CRT)labeled as: 1. VA... Updated software, Brady software maintenance release 6 (SMR6), is now available for the ACCOLADE"... Class I Boston Scientific Corporation
Mar 16, 2026 Flamingo Funnel Large, Model Number SQ20012-03 Certain lots of product were associated with a manufacturing nonconformance involving use of a no... Class II SurgiSmoke Solutions
Mar 16, 2026 Flamingo Funnel Medium, Model Number SQ20012-02 Certain lots of product were associated with a manufacturing nonconformance involving use of a no... Class II SurgiSmoke Solutions
Mar 16, 2026 Access Total T4 Calibrator, Catalog No. 33805 Beckman Coulter has identified that Access Total T4 Calibrator lots (PN 33805) exhibit a negative... Class II Beckman Coulter, Inc.
Mar 16, 2026 Flamingo Funnel Small, Model Number SQ20012-01 Certain lots of product were associated with a manufacturing nonconformance involving use of a no... Class II SurgiSmoke Solutions
Mar 11, 2026 Medtronic Sphere-9 Catheter, Model Number AFR-00001; catheter, percutaneous, ... ventricular fibrillation (VF) during radiofrequency (RF) therapy with the Medtronic Sphere-9 cath... Class II Medtronic, Inc.
Mar 5, 2026 Tornier HRS Max parts: 1. TORNIER HRS Max Tuberosity Body Lat Coat, Small,... Affected products were incorrectly labeled as Tornier HRS Max products. These parts are compatibl... Class II Tornier, Inc
Jan 13, 2026 Octopus Nuvo Tissue Stabilizer, disposable tissue stabilization system, Produ... During the manufacturing, Medtronic personnel identified an assembly issue where the tubing was i... Class II Medtronic Perfusion Systems
Dec 26, 2025 Bandages and first aid kits: FIRST AID KIT 24/42PC, LUCKY FIRST AID BANDAGES... Potential exposure of rodents and rodent activity in the distribution center. Class II GOLD STAR DISTRIBUTION INC
Dec 26, 2025 PREGNANCY TEST 24CT Potential exposure of rodents and rodent activity in the distribution center. Class II GOLD STAR DISTRIBUTION INC
Dec 26, 2025 Condoms, labeled as: TROJAN MAGNUM CONDOMS 6/DSP BLACK, TROJAN LUBRICATED CO... Potential exposure of rodents and rodent activity in the distribution center. Class II GOLD STAR DISTRIBUTION INC
Dec 26, 2025 Toothbrushes, labeled as: ORAL B TOOTH BRUSH SHINY CLEAN SOFT 12CT; COLGATE ... Potential exposure of rodents and rodent activity in the distribution center. Class II GOLD STAR DISTRIBUTION INC
Dec 26, 2025 Feminine hygiene products, labeled as: KOTEX FREEDOM MAXI NO WINGS 48CT, A... Potential exposure of rodents and rodent activity in the distribution center. Class II GOLD STAR DISTRIBUTION INC
Dec 19, 2025 Portex Spinal Tray, Item No. A3729-24 A3595 Affected lots of syringes may have a crack on the syringe collar, which may lead to delayed or re... Class II ICU Medical Inc.
Dec 19, 2025 TORNIER PERFORM REVERSED PERIP SCREW 5.0MMX18MM NON STERILE, catalog number D... A specific lot of screws is incorrectly labeled. Screws are labeled as 5.0mmx18mm but actual scre... Class II Tornier, Inc
Dec 19, 2025 Pulsator Arterial Blood Sampling Kit, Item Numbers 4044EG-1 4080P-2 4084P... Affected lots of syringes may have a crack on the syringe collar, which may lead to delayed or re... Class II ICU Medical Inc.
Dec 8, 2025 Brand Name: HFD100 Product Name: Head Fixation Device HFD100 Model/Catalog ... Torque screw may crack or separate. If used, an affected screw could lead to inadequate head stab... Class II IMRIS Imaging Inc
Dec 4, 2025 Abre Venous Self-Expanding Stent System, Model numbers AB9G14120090 AB9G1210... Stents may be impacted by a Nitinol anomaly which causes a reduced stent diameter when deployed a... Class II Medtronic Inc
Dec 3, 2025 Boston Scientific Coyote OVER-THE-WIRE PTA Balloon Dilation Catheter, 4F, 1... Boston Scientific is initiating the removal of certain batches of Coyote" Over-the-Wire (OTW) Per... Class II Boston Scientific Corporation
Dec 3, 2025 A71200 Vanta" Clinician Programmer Application (CP App) version 2.0.2465 and... Complaints received that Vanta A71200 CP App does not function as intended during use. There is a... Class II Medtronic Neuromodulation
Dec 2, 2025 LYFO DISK, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalo... Affected units may fail to recover the target microorganism Campylobacter jejuni subsp. jejuni de... Class II Microbiologics Inc
Dec 2, 2025 KWIK-STIK 6-Pack, Campylobacter jejuni subsp. jejuni derived from ATCC 29428,... Affected units may fail to recover the target microorganism Campylobacter jejuni subsp. jejuni de... Class II Microbiologics Inc
Dec 2, 2025 KWIK-STIK 2-Pack, Campylobacter jejuni subsp. jejuni derived from ATCC 29428,... Affected units may fail to recover the target microorganism Campylobacter jejuni subsp. jejuni de... Class II Microbiologics Inc
Nov 26, 2025 Beckman Coulter UniCel Dxl 800, Part numbers: 973100, A71456, A71457, A25288... Beckman Coulter has determined that, due to a potential communication issue, the analyzers listed... Class II Beckman Coulter, Inc.
Nov 26, 2025 Beckman Coulter UniCel Dxl 600, Part numbers: A71460, A71461, A30260; Immun... Beckman Coulter has determined that, due to a potential communication issue, the analyzers listed... Class II Beckman Coulter, Inc.
Nov 20, 2025 Restore Clinician Programmer Application (CP App), Model A71100 used with the... Software issue where a Device Reset message displayed on the app was unable to be cleared. In rar... Class II Medtronic Neuromodulation
Nov 13, 2025 KWIK-STIK, Quality control kit for culture media, Vibrio parahaemolyticus der... Some products packaged for lot 818-111-7 may have been packaged in pouches labeled as lot 857-53-10. Class II Microbiologics Inc
Nov 7, 2025 Access 2 Reaction Vessels, individual, disposable, plastic tubes used to proc... It has been determined that certain lots of Access 2 Reaction Vessels may contain manufacturing d... Class II Beckman Coulter, Inc.
Oct 29, 2025 Aurora EV-ICD and Clinical EV-ICD, single chamber, extravascular implantable ... There is a potential for delayed time to high-voltage (HV) therapy should a rare sequence of even... Class II Medtronic, Inc.
Oct 20, 2025 Medtronic HR-ACT (High Range Activated Clotting Time Cartridges), REF 402-03 Medtronic personnel observed trace amounts of dry blood on the external carton label and Instruct... Class II Medtronic Perfusion Systems
Oct 8, 2025 Brand Name: Sterilmed Reprocessed Imaging Catheter Product Name: ACUSON, CAT... Affected catheters were reprocessed beyond validated cycles. This may compromise device sterility... Class II Sterilmed, Inc.
Oct 8, 2025 Brand Name: ACUSON, CATHETER ACUNAV DIAGNOSTIC ULTRASOUND 8FR NOT FOR USE WIT... Affected catheters were reprocessed beyond validated cycles. This may compromise device sterility... Class II Sterilmed, Inc.
Oct 3, 2025 MC3 VitalFlow Console, REF 58100; Blood pump of ecmo As of August 6, 2025, Medtronic has received eleven reports of VitalFlow Consoles displaying an E... Class II Medtronic Perfusion Systems
Oct 1, 2025 Beckman Coulter UniCel DxI 800, Part Numbers: 973100, A71456; Photometric Ch... An internal investigation has determined that due to defective sub-components within the gantry a... Class II Beckman Coulter, Inc.
Oct 1, 2025 Beckman Coulter UniCel DxI 600, Part Numbers: A71460, A30260; Photometric Ch... An internal investigation has determined that due to defective sub-components within the gantry a... Class II Beckman Coulter, 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.