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 |
|---|---|---|---|---|
| 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. |
| Feb 13, 2025 | smiths medical ProPort Low Profile Plastic Venous Access System, Silicone Cat... | 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, Silicone Catheter, 2.87,... | 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, Silicone Catheter, 2.8mm... | The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate... | Class I | Smiths Medical ASD, Inc. |
| Feb 13, 2025 | Portex Endotracheal Tube, Item Codes 100/105/025 100/105/030 100/105/035 100/... | Affected devices have a smaller diameter than expected and may potentially result in inadequate v... | Class I | Smiths Medical ASD, Inc. |
| Feb 13, 2025 | smiths medical ProPort Plastic Venous Access System, Pre-assembled with PolyF... | 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, Pre-assembled with PolyF... | 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, Pre-assembled with PolyF... | 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 Low Profile Plastic Venous Access System, PolyFlow Pol... | 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, Implantable Venous Acces... | The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate... | Class I | Smiths Medical ASD, Inc. |
| Feb 6, 2025 | DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, with Component P... | Beckman Coulter identified that an issue for DxI 9000 tip stocker interface (TSI) and reagent sto... | Class II | Beckman Coulter, Inc. |
| Feb 5, 2025 | DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137. | the DxI 9000 encoder wheel was misaligned on the motor shaft, leading to increased slippage error... | Class II | Beckman Coulter, Inc. |
| Feb 5, 2025 | Access 2 Immunoassay Analyzer, Catalog Number 81600N | Beckman Coulter identified that an issue for Access 2 Sample Motors (B48016) due to improper alig... | Class II | Beckman Coulter, Inc. |
| Feb 5, 2025 | Aortic Root Cannula: 1. DLP Aortic Root Cannula A. CANNULA 11012 AR FLOWGUA... | Unexpected loose material in the male luer used in the aortic root cannula has been identified. P... | Class I | Medtronic Perfusion Systems |
| Feb 3, 2025 | Access Erythropoietin (EPO), Catalog Number - A16364 a glycoprotein (~30,400... | Affected lot (439363) exhibited a negative dose drop of -22% with native patient samples compared... | Class II | Beckman Coulter, Inc. |
| Jan 20, 2025 | Microbiologics Multi-Strain Human Papillomavirus (HPV) Verification Panel (In... | Internal quality control procedures were not followed correctly for the testing/release of three ... | Class II | Microbiologics Inc |
| Jan 20, 2025 | Microbiologics Multi-Strain Human Papillomavirus (HPV) Control Panel (Inactiv... | Internal quality control procedures were not followed correctly for the testing/release of three ... | Class II | Microbiologics Inc |
| Jan 9, 2025 | A820 myPTM Software Application associated with Medtronic SynchroMed Pump and... | Product complaints were received describing the A820 myPTM app taking longer than expected for pa... | Class II | Medtronic Neuromodulation |
| Dec 16, 2024 | Hot Dog PATIENT WARMING, Underbody Warming Mattress + Return Electrode, 89 cm... | There is over-molding that stabilizes the connection between the cable and cable-entry on the mat... | Class II | Augustine Temperature Management, LLC |
| Dec 16, 2024 | Hot Dog PATIENT WARMING, Underbody Warming Mattress + Return Electrode, 82 cm... | There is over-molding that stabilizes the connection between the cable and cable-entry on the mat... | Class II | Augustine Temperature Management, LLC |
| Dec 16, 2024 | Hot Dog PATIENT WARMING, Underbody Warming Mattress + Return Electrode, 127 c... | There is over-molding that stabilizes the connection between the cable and cable-entry on the mat... | Class II | Augustine Temperature Management, LLC |
| Dec 12, 2024 | Select Series Angled Tip Arterial Cannula, Model Number 72422 (22 Fr) | Incorrect labeling for seven manufactured lots of certain models of Arterial Cannulae. | Class II | Medtronic Perfusion Systems |
| Dec 12, 2024 | ALTRUA 2 DR Pacemaker, SL (Model Number S702) and EL (Model Number S722) | A subset of devices from the ACCOLADE Family of Pacemakers and CRT-Ps, built before September 201... | Class I | Boston Scientific Corporation |
| Dec 12, 2024 | VISIONIST CRT-P, EL (Model Number U225 and U226) and EL MRI (Model Number U228) | A subset of devices from the ACCOLADE Family of Pacemakers and CRT-Ps, built before September 201... | Class I | Boston Scientific Corporation |
| Dec 12, 2024 | EOPA Arterial Cannula, Model Numbers 77422 (22 Fr) and 77418 (18 Fr) | Incorrect labeling for seven manufactured lots of certain models of Arterial Cannulae. | Class II | Medtronic Perfusion Systems |
| Dec 12, 2024 | ESSENTIO DR Pacemaker, SL (Model Number L101, SL MRI (Model Number L111), EL ... | A subset of devices from the ACCOLADE Family of Pacemakers and CRT-Ps, built before September 201... | Class I | Boston Scientific Corporation |
| Dec 12, 2024 | ACCOLADE DR Pacemaker, SL (Model Number L301), SL MRI (Model Number L311), EL... | A subset of devices from the ACCOLADE Family of Pacemakers and CRT-Ps, built before September 201... | Class I | Boston Scientific Corporation |
| Dec 12, 2024 | PROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209),... | A subset of devices from the ACCOLADE Family of Pacemakers and CRT-Ps, built before September 201... | Class I | Boston Scientific Corporation |
| Dec 12, 2024 | VALITUDE CRT-P, EL (Model Number U125) and EL MRI (Model Number U128) | A subset of devices from the ACCOLADE Family of Pacemakers and CRT-Ps, built before September 201... | 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.