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 |
|---|---|---|---|---|
| Aug 16, 2023 | Medfusion Syringe Pump, Model 4000-XXXX-XX: a) 0100-50, b) 0100-249, c) ... | A force sensor in the occlusion detector may drift out of calibration leading to increased occlus... | Class II | Smiths Medical ASD Inc. |
| Aug 16, 2023 | Medfusion Syringe Pump, Model 3500-0600-XX: a) 0600-00; b) 0600-01; c) 0... | A force sensor in the occlusion detector may drift out of calibration leading to increased occlus... | Class II | Smiths Medical ASD Inc. |
| Aug 16, 2023 | Medfusion Syringe Pump, Model 3500-500, v3, v4, v5, and v6 | A force sensor in the occlusion detector may drift out of calibration leading to increased occlus... | Class II | Smiths Medical ASD Inc. |
| Aug 14, 2023 | KWIK-STIK, ANA (3 Strains) QC Set, REF 5065P; Microbiological testing | One lot of KWIK STIK ANA (3 strains) QC Set is missing one of the strains, 6018P Parabacteroides ... | Class III | Microbiologics Inc |
| Jul 27, 2023 | Guider Softip Guide Catheter 7F PRE-SHAPED 40 90CM, Catalog number H965100430... | Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear t... | Class II | Boston Scientific Corporation |
| Jul 27, 2023 | Guider Softip Guide Catheter 6F PRE-SHAPED 40 100CM, Catalog number M00310142... | Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear t... | Class II | Boston Scientific Corporation |
| Jul 27, 2023 | Guider Softip Guide Catheter 7F PRE-SHAPED 40 100CM, Catalog number M00310143... | Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear t... | Class II | Boston Scientific Corporation |
| Jul 27, 2023 | Guider Softip Guide Catheter 6F 100CM MULTI PURPOSE, Catalog number M00310146... | Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear t... | Class II | Boston Scientific Corporation |
| Jul 27, 2023 | Guider Softip Guide Catheter 7F 90CM MULTI PURPOSE, Catalog number H965100470... | Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear t... | Class II | Boston Scientific Corporation |
| Jul 27, 2023 | Guider Softip Guide Catheter 5F PRE-SHAPED 40 100CM, Catalog number M00310162... | Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear t... | Class II | Boston Scientific Corporation |
| Jul 27, 2023 | Guider Softip Guide Catheter 8F PRE-SHAPED 40 100CM, Catalog number M00310144... | Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear t... | Class II | Boston Scientific Corporation |
| Jul 27, 2023 | Guider Softip Guide Catheter 8F 100CM MULTI PURPOSE, Catalog number M00310148... | Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear t... | Class II | Boston Scientific Corporation |
| Jul 27, 2023 | Guider Softip Guide Catheter 8F PRE-SHAPED 40 90CM, Catalog number H965100440... | Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear t... | Class II | Boston Scientific Corporation |
| Jul 27, 2023 | Guider Softip Guide Catheter 7F 100CM MULTI PURPOSE, Catalog number M00310147... | Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear t... | Class II | Boston Scientific Corporation |
| Jul 27, 2023 | Guider Softip Guide Catheter 5F 90CM MULTI PURPOSE, Catalog number M003100630... | Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear t... | Class II | Boston Scientific Corporation |
| Jul 27, 2023 | Guider Softip Guide Catheter 6F PRE-SHAPED 40 90CM, Catalog number H965100420... | Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear t... | Class II | Boston Scientific Corporation |
| Jul 27, 2023 | Guider Softip Guide Catheter 6F 90CM MULTI PURPOSE, Catalog number H965100460... | Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear t... | Class II | Boston Scientific Corporation |
| Jul 27, 2023 | Guider Softip Guide Catheter 5F PRE-SHAPED 40 90CM, Catalog number M003100620... | Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear t... | Class II | Boston Scientific Corporation |
| Jul 27, 2023 | Guider Softip Guide Catheter 8F 90CM MULTI PURPOSE, Catalog number H965100480... | Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear t... | Class II | Boston Scientific Corporation |
| Jul 27, 2023 | Guider Softip Guide Catheter 5F 100CM MULTI PURPOSE, Catalog number M00310163... | Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear t... | Class II | Boston Scientific Corporation |
| Jul 18, 2023 | PORTEX 0.5u HYDROPHOBIC DISC FILTER, REF 002291 - Bacterial/Viral filter | Smiths Medical identified a labeling error in which the barcode (UDI) was not correctly reflectin... | Class II | Smiths Medical ASD Inc. |
| Jul 11, 2023 | EMBLEM MRI S-ICD Pulse Generator Model A219; Subcutaneous Implantable Cardiov... | There is a potential for a rare interaction between the EMBLEM S-ICD and LATITUDE communicator, w... | Class II | Boston Scientific Corporation |
| Jul 11, 2023 | EMBLEM S-ICD Pulse Generator Model A209; Subcutaneous Implantable Cardioverte... | There is a potential for a rare interaction between the EMBLEM S-ICD and LATITUDE communicator, w... | Class II | Boston Scientific Corporation |
| Jul 6, 2023 | Access Thyroglobulin Calibrators | It has been determined through an internal investigation that the alternate Access Thyroglobulin ... | Class II | Beckman Coulter, Inc. |
| Jul 6, 2023 | Medtronic InterStim Ground Pad REF 041826 | Lot of InterStim Self-Adhesive Ground Pad is being recalled due to the product being labeled with... | Class II | Medtronic Neuromodulation |
| Jun 23, 2023 | Equipment and table drapes and Surgical Room Turnover (SRT) Kits: (1) Ecol... | Certain lots of the products have a Naphthalene odor. | Class II | Microtek Medical Inc. |
| Jun 23, 2023 | Equipment and table drapes: (1) Ecolab Banded Bag with Rubberband and Tape... | Certain lots of the products have a Naphthalene odor. | Class II | Microtek Medical Inc. |
| Jun 21, 2023 | A901 Communication Manager Application, used in conjunction with the A710 Cli... | When an update to the A710 Clinician Programmer software application for the Intellis Neurostimul... | Class II | Medtronic Neuromodulation |
| Jun 20, 2023 | Ringed DxI Reaction Vessels (RVs) | Beckman Coulter, Inc. is recalling Ringed DxI Reaction Vessels (RVs) as part of Unicel DxI Immuno... | Class II | Beckman Coulter, Inc. |
| Jun 12, 2023 | Abbott Amplatzer Steerable Delivery Sheath (ASDS), REF ASDS-14F-075, is a per... | There is an overall reported incidence rate of 0.77% related to observed or potential air embolis... | Class I | Abbott |
| Jun 12, 2023 | AEQUALIS FLEX REVIVE Assembly Screw 0mm, Model Number ARS655101 | A comingle/swap resulted in the labeling and laser marking on the product to state it is a Aequal... | Class II | Tornier, Inc |
| Jun 12, 2023 | AEQUALIS FLEX REVIVE Assembly Screw 0mm Short, Model Number ARS655118 | A comingle/swap resulted in the labeling and laser marking on the product to state it is a Aequal... | Class II | Tornier, Inc |
| Jun 6, 2023 | Vios Monitoring System Bedside Monitor, Model BSM2050, Software Version Numbe... | A premature failure condition was identified with the L2050R pulse oximeter SpO2 sensor that conn... | Class II | Murata Vios, Inc. |
| Jun 6, 2023 | Vanta with AdaptiveStim Implantable Neurostimulator, Model 977006; spinal cho... | A cardioversion procedure may damage the electronics in the Vanta INS device, making the INS unre... | Class II | Medtronic Neuromodulation |
| May 22, 2023 | Medtronic ILLUMISITE Platform Console, Model Number ILS-1000-CS | Single ILLUMISITE Platform Console was converted from a 220-240VAC model to a 120VAC configuratio... | Class II | Covidien, LLC |
| May 17, 2023 | Access Hybritech p2PSA reagent, REF B03704 and REF A49752. | Reagent lot numbers include an insufficient concentration of blocking reagent. | Class II | Beckman Coulter, Inc. |
| May 10, 2023 | CRT-D DTBA2D4 VIVA XT IS1/DF4 INTL, Model Number DTBA2D4; Implantable Cardio... | There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typi... | Class I | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| May 10, 2023 | CRT-D DTBB2Q1 VIVA QUAD S IS4/DF1 INTL, Model Number DTBB2Q1; Implantable Ca... | There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typi... | Class I | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| May 10, 2023 | CRTD DTPA2D1G COBALT XT HF QUAD OUS, Model Number DTPA2D1G; Implantable Card... | There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typi... | Class I | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| May 10, 2023 | ICD COBALT VR MRI IS1 DF1, Model Number DVPB3D1; Implantable Cardioverter De... | There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typi... | Class I | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| May 10, 2023 | ICD-DR DDMB1D4 EVERA MRI XT IS-1/DF4 US, Model Number DDMB1D4; Implantable C... | There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typi... | Class I | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| May 10, 2023 | ICD-VR DVAB1D4 VISIA AF US DF4, Model Number DVAB1D4; Implantable Cardiovert... | There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typi... | Class I | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| May 10, 2023 | CRTD CROME HF QUAD MRI IS4 DF4, Model Number DTPC2QQ; Implantable Cardiovert... | There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typi... | Class I | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| May 10, 2023 | ICD-VR DVAB1D1 VISIA AF US IS1/DF1, Model Number DVAB1D1; Implantable Cardio... | There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typi... | Class I | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| May 10, 2023 | CRT-D DTBC2Q1 BRAVA QUAD IS4/DF1 INTL, Model Number DTBC2Q1; Implantable Car... | There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typi... | Class I | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| May 10, 2023 | ICD COBALT XT VR MRI DF4, Model Number DVPA2D4; Implantable Cardioverter Def... | There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typi... | Class I | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| May 10, 2023 | ICD CROME VR MRI DF4, Model Number DVPC3D4; Implantable Cardioverter Defibri... | There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typi... | Class I | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| May 10, 2023 | ICD EVERA XT DR GOLD CTD, Model Number DDBB1D4G; Implantable Cardioverter De... | There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typi... | Class I | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| May 10, 2023 | CRTD COBALT XT HF MRI IS1 DF1, Model Number DTPA2D1; Implantable Cardioverte... | There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typi... | Class I | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| May 10, 2023 | CRTD DTPA2D1PX COBALT XT HF QUAD OUS, Model Number DTPA2D1PX; Implantable Ca... | There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typi... | Class I | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
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.