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 |
|---|---|---|---|---|
| Jun 25, 2025 | UniCel DxI 800 Access Immunoassay Analyzer, Part Number 973100 | Beckman Coulter has identified that the UniCel DxI 600/800 systems with linear slide PnP gantries... | Class II | Beckman Coulter, Inc. |
| Jun 25, 2025 | UniCel DxI 600 Access Immunoassay Analyzer, Part Number A30260 | Beckman Coulter has identified that the UniCel DxI 600/800 systems with linear slide PnP gantries... | Class II | Beckman Coulter, Inc. |
| Jun 25, 2025 | DxI 600 Access Immunoassay Analyzer W/Dual Gantry, Part Number A71461 | Beckman Coulter has identified that the UniCel DxI 600/800 systems with linear slide PnP gantries... | Class II | Beckman Coulter, Inc. |
| Jun 25, 2025 | FARAWAVE 1.0 Pulsed Field Ablation Catheter, Product ID M004PF41M401 | The potentially impacted units were manufactured using specific equipment that may have caused cr... | Class II | Boston Scientific Corporation |
| Jun 25, 2025 | DxI 800 Access Immunoassay Analyzer W/Spot B, Part Number A71456 | Beckman Coulter has identified that the UniCel DxI 600/800 systems with linear slide PnP gantries... | Class II | Beckman Coulter, Inc. |
| Jun 25, 2025 | DxI 600 Access Immunoassay Analyzer W/Spot B, Part Number A71460 | Beckman Coulter has identified that the UniCel DxI 600/800 systems with linear slide PnP gantries... | Class II | Beckman Coulter, Inc. |
| Jun 25, 2025 | DxI 800 Access Immunoassay Analyzer W/Dual Gantry, Part Number A71457 | Beckman Coulter has identified that the UniCel DxI 600/800 systems with linear slide PnP gantries... | Class II | Beckman Coulter, Inc. |
| Jun 18, 2025 | Medtronic CareLink SmartSync Device Manager, Model Number 24967A with the fol... | In prior SmartSync application versions, the Abort button stopped the test that was selected. Dur... | Class II | Medtronic, Inc. |
| Jun 18, 2025 | Medtronic CareLink SmartSync Patient Connector, Model Number 24967 with the f... | In prior SmartSync application versions, the Abort button stopped the test that was selected. Dur... | Class II | Medtronic, Inc. |
| Jun 17, 2025 | KWIK-STIK and LYFO DISK, quality control kit for culture media Catalog # 080... | Affected products contain Staphylococcus epidermidis instead of the expected Brevundimonas diminu... | Class II | Microbiologics Inc |
| Jun 17, 2025 | Medtronic SmartLink software loaded on CareLink SmartSync Device Manager, Mod... | A software update for Medtronic CareLink SmartSync Device Manager (SmartSync) is now available. ... | Class II | Medtronic, Inc. |
| Jun 17, 2025 | Medtronic SmartLink Software loaded on SmartSync Patient Connector, Model Num... | A software update for Medtronic CareLink SmartSync Device Manager (SmartSync) is now available. ... | Class II | Medtronic, Inc. |
| Jun 10, 2025 | VersaCross Transseptal Sheath Kit (VXS) Product Description/IDs VXS0201 VX... | Potential for hole in the Tyvek layer of the sterile barrier pouch, which may compromise device s... | Class II | Boston Scientific Corporation |
| Jun 10, 2025 | VersaCross RF Wire (VXW). Indicated for creation of an atrial septal defect i... | Potential for hole in the Tyvek layer of the sterile barrier pouch, which may compromise device s... | Class II | Boston Scientific Corporation |
| Jun 10, 2025 | VersaCross Access Solution (VXSK), Product Description and ID: VXSK (180J... | Potential for hole in the Tyvek layer of the sterile barrier pouch, which may compromise device s... | Class II | Boston Scientific Corporation |
| Jun 10, 2025 | Torflex Transseptal Guiding Sheath Kit (TFK-M) TF85-32-63-45 TORFLEX 8.5F... | Potential for hole in the Tyvek layer of the sterile barrier pouch, which may compromise device s... | Class II | Boston Scientific Corporation |
| May 27, 2025 | KWIK-STICK, Quality control kit for culture media, Catalog Numbers 01065K... | Affected products were packaged with the incorrect KWIK STIK assembly resulting in the product co... | Class II | Microbiologics Inc |
| May 22, 2025 | IontoPatch STAT, On-the-Go Patch Therapy, Model/Catalog Number D-0062-080; Io... | The nonwoven pads in the device do not absorb the saline solution or any other liquid intended to... | Class II | LTS Therapy Systems, LLC |
| May 22, 2025 | IontoPatch 80, On-the-Go Patch Therapy, Model/Catalog Number: D-0077-080; T... | The nonwoven pads in the device do not absorb the saline solution or any other liquid intended to... | Class II | LTS Therapy Systems, LLC |
| May 7, 2025 | DxI 9000 Access Immunoassay Analyzer C11137 | Analyzer has calibration issues where curves switched from passed to failed due to system errors ... | Class II | Beckman Coulter, Inc. |
| May 5, 2025 | Access Testosterone assay, Catalog Number 33560 | Inadequate preventative maintenance (PM) performed on the scales of the RPL5 fill line, led to s... | Class II | Beckman Coulter, Inc. |
| Apr 29, 2025 | Azure S DR MRI SureScan, Product number W3DR01 | Identified devices may experience sudden battery power failure without alarm, power supply power-... | Class II | Medtronic, Inc. |
| Apr 23, 2025 | DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, running software... | A new motor/encoder and cable was introduced into instruments manufactured starting with serial n... | Class II | Beckman Coulter, Inc. |
| Apr 23, 2025 | DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, running software... | A new software update (v1.20) is introducing error codes for the Dxl 9000 which prevents the assa... | Class II | Beckman Coulter, Inc. |
| Apr 22, 2025 | 3M Ranger Irrigation Fluid Warming Set, REF 24750 | Notice was issued to clarify flow rates related to the inlet fluid temperature. | Class II | 3M Company |
| Apr 10, 2025 | CADD Solis HSPCA Pump | Pumps may experience Wireless Connection Modules intermittent connection alarms, which will inter... | Class I | Smiths Medical ASD, Inc. |
| Apr 10, 2025 | CADD-Solis Infusion Pump Models: 1) PUMP KIT, CADD-SOLIS, MDL 2110, V4.2, ... | There is a potential for thermal damage in CADD-Solis and CADD- Solis VIP infusion pumps. | Class I | Smiths Medical ASD, Inc. |
| Apr 10, 2025 | CADD Solis VIP Ambulatory Infusion Pump Models: 1) PUMP KIT, CADD-SOLIS VI... | There is a potential for thermal damage in CADD-Solis and CADD- Solis VIP infusion pumps. | Class I | Smiths Medical ASD, Inc. |
| Apr 10, 2025 | CADD-Solis VIP Ambulatory Infusion Pump; Model/Number: 21-2120-0100-02 ... | Affected pumps may trigger an erroneous (false) Upstream Occlusion Alarm under certain conditions... | Class I | Smiths Medical ASD, Inc. |
| Apr 10, 2025 | 3M Ranger Blood/Fluid Warming High Flow Set Catalog Numbers 24355, 24370 | Field action to clarify the flow rates and inlet fluid temperatures, along with location of the o... | Class I | 3M Company |
| Apr 10, 2025 | CADD-Solis HPCA Ambulatory Infusion Pump; Model/Number: 21-2111-0402-09-KYO... | Affected pumps may trigger an erroneous (false) Upstream Occlusion Alarm under certain conditions... | Class I | Smiths Medical ASD, Inc. |
| Apr 3, 2025 | Enhanced Verify Evaluation Handset (CFN HH90130FA) | Evaluation handsets may not be able to communicate with the neurostimulator due to handsets havin... | Class II | Medtronic Neuromodulation |
| Mar 27, 2025 | Beckman Coulter DxI 9000 Access Immunoassay Analyzer | When DxI 9000 Access Immunoassay Analyzer is connected to a host system (laboratory information s... | Class II | Beckman Coulter, Inc. |
| Mar 24, 2025 | IceSeed 1.5 CX NEEDLE US, Cryoablation Needle, REF H7493967433170. The needl... | Boston Scientific has identified that IceSeedTM CX needles manufactured between April 2024 and Fe... | Class II | Boston Scientific Corporation |
| Mar 24, 2025 | IceSeed 1.5 CX S NEEDLE US, Cryoablation Needle, REF H7493967233100. The nee... | Boston Scientific has identified that IceSeedTM CX needles manufactured between April 2024 and Fe... | Class II | Boston Scientific Corporation |
| Mar 24, 2025 | IceSeed 1.5 CX NEEDLE OUS, Cryoablation Needle, REF H7493967534170. The need... | Boston Scientific has identified that IceSeedTM CX needles manufactured between April 2024 and Fe... | Class II | Boston Scientific Corporation |
| Mar 24, 2025 | IceSeed 1.5 CX S NEEDLE OUS, Cryoablation Needle, REF H7493967334100. The ne... | Boston Scientific has identified that IceSeedTM CX needles manufactured between April 2024 and Fe... | Class II | Boston Scientific Corporation |
| Mar 17, 2025 | Amplatzer TorqVue LP Catheter (TVLPC), Model no. 9-TVLPC4F90/080 | Device may have a small breach in the proximal end of the shaft under the strain relief of the de... | Class II | Abbott |
| Mar 17, 2025 | Amplatzer TorqVue LP Delivery System (TVLP), Model nos. 9-TVLP4F90/060 and 9-... | Device may have a small breach in the proximal end of the shaft under the strain relief of the de... | Class II | Abbott |
| Mar 4, 2025 | Stimulation RC Clinician Programmer Application, Model A71400, when used with... | There is a software issue that can permanently disable communication with an implantable neurosti... | Class II | Medtronic Neuromodulation |
| Mar 3, 2025 | stryker Latitude EV HUMERAL REVISION STEM TRIAL, L: 150mm, Size: LARGE, Side... | A specific lot of Latitude Humeral Trial Stems has the incorrect direct part marking. " Laser Ma... | Class II | Tornier, Inc |
| Feb 27, 2025 | Access Vitamin B12 Reagent, Catalog Number 33000, Lot Number 439850 | Beckman Coulter has received complaints of erroneous Vitamin B12 results when using Access Vitami... | Class II | Beckman Coulter, Inc. |
| Feb 20, 2025 | Helix Elite Inactivated Standard: Inactivated Influenza A/B and Respiratory S... | The RSV target may give a late Ct value and could potentially not pass QC. | Class II | Microbiologics Inc |
| Feb 20, 2025 | Helix Elite" Inactivated Standard: Inactivated SARS-CoV-2 Whole Virus (Pellet... | The A549 human cell target (human cells for sample adequacy control) may give a late Ct value. | Class II | Microbiologics Inc |
| Feb 14, 2025 | CAPNOCHECK BCI Airway Adapter; Model Number BSR; Product Code WW8214 | Airway adapter does not meet specification and may break off when attaching a valve or tube. Devi... | Class II | Smiths Medical ASD, Inc. |
| Feb 14, 2025 | CAPNOCHECK BCI Airway Adapter; Model Number BSR; Product Code WW1100 | Airway adapter does not meet specification and may break off when attaching a valve or tube. Devi... | Class II | Smiths Medical ASD, Inc. |
| Feb 13, 2025 | smiths medical ProPort Plastic Venous Access System, PolyFlow Polyurethane Ca... | The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate... | Class I | Smiths Medical ASD, Inc. |
| Feb 13, 2025 | smiths medical ProPort Plastic Venous Access System, PolyFlow Polyurethane Ca... | The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate... | Class I | Smiths Medical ASD, Inc. |
| Feb 13, 2025 | smiths medical ProPort Plastic Venous Access System, PolyFlow Catheter, 2.6 (... | The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate... | Class I | Smiths Medical ASD, Inc. |
| Feb 13, 2025 | smiths medical ProPort Plastic Venous Access System, PolyFlow Polyurethane Ca... | The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate... | Class I | 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.