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 |
|---|---|---|---|---|
| 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. |
| Sep 30, 2025 | IMRIS Operating Suite, iMRI 3T S, containing Siemens 3 Tesla MRI Magnet, Skyra | There is a potential safety issue associated with the magnet venting paths of the Siemens 3 Tesla... | Class I | IMPRIS Imaging Inc |
| Sep 30, 2025 | IMRIS Operating Suite, IMRIS iMRI 3T V, containing Siemens 3 Tesla MRI Magnet... | There is a potential safety issue associated with the magnet venting paths of the Siemens 3 Tesla... | Class I | IMPRIS Imaging Inc |
| Sep 30, 2025 | IMRIS Operating Suite, InVision 3T Operating Suite, containing Siemens 3 Tesl... | There is a potential safety issue associated with the magnet venting paths of the Siemens 3 Tesla... | Class I | IMPRIS Imaging Inc |
| Sep 30, 2025 | IMRIS Operating Suite, Neuro III-SV iMRI System, iMRX System, containing Siem... | There is a potential safety issue associated with the magnet venting paths of the Siemens 3 Tesla... | Class I | IMPRIS Imaging Inc |
| Sep 19, 2025 | DxC 500i Clinical Analyzer Modules, DxC 500 AU Module w/ISE, DxC 500i (Part N... | Beckman Coulter has confirmed a software anomaly on DxI 9000 Access Immunoassay Analyzer and the ... | Class II | Beckman Coulter, Inc. |
| Sep 19, 2025 | DxI 9000 Access Immunoassay Analyzer, Part Number C11137 | Beckman Coulter has confirmed a software anomaly on DxI 9000 Access Immunoassay Analyzer and the ... | Class II | Beckman Coulter, Inc. |
| Sep 12, 2025 | Affinity NT Oxygenator, Oxygenator with Balance Biosurface and Uncoated Cardi... | Medtronic identified an Affinity NT Oxygenator unit with decreased CO2 gas transfer rates that di... | Class II | Medtronic Perfusion Systems |
| Sep 10, 2025 | TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, DF, (BiD Curve D-F), ... | Abbott has become aware of a limited number of tip detachment events during catheter removal from... | Class I | Abbott |
| Sep 10, 2025 | TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, F, (UniD Curve F), RE... | Abbott has become aware of a limited number of tip detachment events during catheter removal from... | Class I | Abbott |
| Sep 10, 2025 | TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, D, (UniD Curve D), RE... | Abbott has become aware of a limited number of tip detachment events during catheter removal from... | Class I | Abbott |
| Sep 10, 2025 | TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, DD, (BiD Curve D-D), ... | Abbott has become aware of a limited number of tip detachment events during catheter removal from... | Class I | Abbott |
| Sep 10, 2025 | TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, FJ, (BiD Curve F-J), ... | Abbott has become aware of a limited number of tip detachment events during catheter removal from... | Class I | Abbott |
| Aug 20, 2025 | ACCOLADE DR SL MRI (Model L311) | Software to enhance Safety Architecture is available and designed to prevent initiation of Safety... | Class I | Boston Scientific Corporation |
| Aug 20, 2025 | Model Number S722, ALTRUA 2 DR EL Pacemaker | Software to enhance Safety Architecture is available and designed to prevent initiation of Safety... | Class I | Boston Scientific Corporation |
| Aug 20, 2025 | PROPONENT DR SL (Model L201) | Software to enhance Safety Architecture is available and designed to prevent initiation of Safety... | Class I | Boston Scientific Corporation |
| Aug 20, 2025 | ACCOLADE SR SL MRI (Model L310) | Software to enhance Safety Architecture is available and designed to prevent initiation of Safety... | Class I | Boston Scientific Corporation |
| Aug 20, 2025 | Model Number L100, ESSENTIO SR SL Pacemaker | Software to enhance Safety Architecture is available and designed to prevent initiation of Safety... | Class I | Boston Scientific Corporation |
| Aug 20, 2025 | Model Number U125, VALITUDE CRT-P EL | Software to enhance Safety Architecture is available and designed to prevent initiation of Safety... | Class I | Boston Scientific Corporation |
| Aug 20, 2025 | ACCOLADE SR SL (Model L300) | Software to enhance Safety Architecture is available and designed to prevent initiation of Safety... | Class I | Boston Scientific Corporation |
| Aug 20, 2025 | Model Number L111, ESSENTIO DR SL MRI Pacemaker | Software to enhance Safety Architecture is available and designed to prevent initiation of Safety... | Class I | Boston Scientific Corporation |
| Aug 20, 2025 | Model Number S701 ALTRUA 2 SR SL Pacemaker | Software to enhance Safety Architecture is available and designed to prevent initiation of Safety... | Class I | Boston Scientific Corporation |
| Aug 20, 2025 | ACCOLADE DR EL (Model L321) | Software to enhance Safety Architecture is available and designed to prevent initiation of Safety... | Class I | Boston Scientific Corporation |
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.