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 |
|---|---|---|---|---|
| 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.