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 |
|---|---|---|---|---|
| May 10, 2023 | CRTD CROME HF MRI IS1 DF4, Model Number DTPC2D4; 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 | CRT-D DTBA1Q1 VIVA QUAD XT IS4/DF1 US, Model Number DTBA1Q1; 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 | CRT-D DTBA2QQ VIVA QUAD XT IS4/DF4 INTL, Model Number DTBA2QQ; 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 | CRT-D DTBB2D4 VIVA S IS1/DF4 INTL, Model Number DTBB2D4; Implantable Cardiov... | 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 DDPA2D1G COBALT XT DR MRI DF1 GOLD, Model Number DDPA2D1G; 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-DR DDBB2D1 EVERA XT IS1/DF1 INTL, Model Number DDBB2D1; 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 9, 2023 | vRad PACS with Mammography | The error resulted in intermittent failure of current (primary) radiology study images not displa... | Class II | Virtual Radiologic Corp. |
| Apr 6, 2023 | 3M Attest Steam Chemical Integrators, REF 1243A | 3M Attest Steam Chemical Integrators with dates of manufacture between November 6, 2022 and Janua... | Class II | 3M Company - Health Care Business |
| Apr 6, 2023 | 3M Attest Steam Chemical Integrators, REF 1243B | 3M Attest Steam Chemical Integrators with dates of manufacture between November 6, 2022 and Janua... | Class II | 3M Company - Health Care Business |
| Apr 5, 2023 | DuraLife Autoclavable Silicone Extension Tube, REF 60-1502 (UltraSet Product ... | DuraLife devices instructions for cleaning and sterilization have been determined to be inadequat... | Class II | Smiths Medical ASD Inc. |
| Apr 5, 2023 | DuraLife Autoclavable Silicone Extension Tube, REF 60-1510 (UltraSet Product ... | DuraLife devices instructions for cleaning and sterilization have been determined to be inadequat... | Class II | Smiths Medical ASD Inc. |
| Apr 5, 2023 | DuraLife Autoclavable Double Swivel Elbow, REF 60-0010 (UltraSet Product Code... | DuraLife devices instructions for cleaning and sterilization have been determined to be inadequat... | Class II | Smiths Medical ASD Inc. |
| Apr 5, 2023 | WATCHDOG ACCESSORY KIT (20-PACK), UPN H74939343A021 (outer package), UPN H749... | The firm received complaints of the Insertion Tool component being occluded, resulting in the ina... | Class II | Boston Scientific Corporation |
| Apr 5, 2023 | WATCHDOG Hemostasis Valve Kit, UPN H74939343A022 (outer package), UPN H749393... | The firm received complaints of the Insertion Tool component being occluded, resulting in the ina... | Class II | Boston Scientific Corporation |
| Mar 30, 2023 | Medicine Dropper, Product Code K508 | Potential for glass dropper to have glass particulate on the outside surface of the dropper bulb. | Class II | Apothecary Products, LLC |
| Mar 30, 2023 | Eye and Ear Dropper, Product Code 67082 | Potential for glass dropper to have glass particulate on the outside surface of the dropper bulb. | Class II | Apothecary Products, LLC |
| Mar 17, 2023 | Medtronic SenSight Extension Tunneler Kit, REF B31030; The Extension Tunneler... | Medtronic has received reports of SenSight Extension Tunneler kits that contain dual carriers wit... | Class II | Medtronic Neuromodulation |
| Mar 15, 2023 | Beckman Coulter Access Free T3, Triiodothyronine, Free, Catalog #A13422, each... | The reagent lot produces elevated results (approximately >30%) in some (15-20%)patient samples th... | Class II | Beckman Coulter, Inc. |
| Mar 14, 2023 | ADVANCED RESEARCH MEDICAL Lumbar Interbody Fusion System (OLLIF), Flexible Cu... | Potential shearing of the disposable blade may occur and be contained within the of Flexible Cure... | Class II | Advanced Research Medical, LLC |
| Mar 1, 2023 | Titan NB Infra Zero Ang 16cm, Catalog Number EN88162400; inflatable penile Pr... | A decrease in wall thickness has the potential for a premature pump failure, compared to a pump w... | Class II | Coloplast Manufacturing US, LLC |
| Mar 1, 2023 | Titan Touch Pump, Catalog Numbers 5177502400; inflatable penile Prosthesis | A decrease in wall thickness has the potential for a premature pump failure, compared to a pump w... | Class II | Coloplast Manufacturing US, LLC |
| Mar 1, 2023 | Titan 0-Deg Scrotal 18 Cm, Catalog Number ES89182400; inflatable penile Prost... | A decrease in wall thickness has the potential for a premature pump failure, compared to a pump w... | Class II | Coloplast Manufacturing US, LLC |
| Mar 1, 2023 | Titan Touch NB Infr Zero 18cm, Catalog Number EN28182400; inflatable penile P... | A decrease in wall thickness has the potential for a premature pump failure, compared to a pump w... | Class II | Coloplast Manufacturing US, LLC |
| Mar 1, 2023 | Titan 0-Deg Scrotal 22 Cm, Catalog Number ES89222400; inflatable penile Prost... | A decrease in wall thickness has the potential for a premature pump failure, compared to a pump w... | Class II | Coloplast Manufacturing US, LLC |
| Mar 1, 2023 | Titan Touch Infr Zero Ang 22cm, Catalog Number ES28222400; inflatable penile ... | A decrease in wall thickness has the potential for a premature pump failure, compared to a pump w... | Class II | Coloplast Manufacturing US, LLC |
| Mar 1, 2023 | Titan 0-Deg Infrapubic 20 Cm, Catalog Number ES88202400; inflatable penile Pr... | A decrease in wall thickness has the potential for a premature pump failure, compared to a pump w... | Class II | Coloplast Manufacturing US, LLC |
| Mar 1, 2023 | Titan Touch NB Infr Zero 16cm, Catalog Number EN28162400; inflatable penile P... | A decrease in wall thickness has the potential for a premature pump failure, compared to a pump w... | Class II | Coloplast Manufacturing US, LLC |
| Mar 1, 2023 | Titan 0-Deg Scrotal 20 Cm, Catalog Number ES89202400; inflatable penile Prost... | XXX | Class II | Coloplast Manufacturing US, LLC |
| Mar 1, 2023 | Titan Touch NB Scrot Zero 16cm, Catalog Number EN29162400; inflatable penile ... | A decrease in wall thickness has the potential for a premature pump failure, compared to a pump w... | Class II | Coloplast Manufacturing US, LLC |
| Mar 1, 2023 | Titan Touch Infr Zero Ang 18cm, Catalog Number ES28182400; inflatable penile ... | A decrease in wall thickness has the potential for a premature pump failure, compared to a pump w... | Class II | Coloplast Manufacturing US, LLC |
| Mar 1, 2023 | Titan Touch Scro Zero Ang 16cm, Catalog Number ES29162400; inflatable penile ... | A decrease in wall thickness has the potential for a premature pump failure, compared to a pump w... | Class II | Coloplast Manufacturing US, LLC |
| Mar 1, 2023 | Titan Touch Scro Zero Ang 20cm, Catalog Number ES29202400; inflatable penile ... | A decrease in wall thickness has the potential for a premature pump failure, compared to a pump w... | Class II | Coloplast Manufacturing US, LLC |
| Mar 1, 2023 | Titan Touch Scro Zero Ang 22cm, Catalog Number ES29222400; inflatable penile ... | A decrease in wall thickness has the potential for a premature pump failure, compared to a pump w... | Class II | Coloplast Manufacturing US, LLC |
| Mar 1, 2023 | Titan Touch NB Scrot Zero 18cm, Catalog Number EN29182400; inflatable penile ... | A decrease in wall thickness has the potential for a premature pump failure, compared to a pump w... | Class II | Coloplast Manufacturing US, LLC |
| Mar 1, 2023 | Titan NB Scrotal Zero Ang 18cm, Catalog Number EN88182400; inflatable penile ... | A decrease in wall thickness has the potential for a premature pump failure, compared to a pump w... | Class II | Coloplast Manufacturing US, LLC |
| Mar 1, 2023 | Titan Pump Assembly, Catalog Number 5177701400; inflatable penile Prosthesis | A decrease in wall thickness has the potential for a premature pump failure, compared to a pump w... | Class II | Coloplast Manufacturing US, LLC |
| Feb 2, 2023 | LATITUDE NXT Remote Patient Management System, LATITUDE NXT System Server Sof... | Under specific circumstances, the U.S. product registration system did not send up enablement req... | Class II | Boston Scientific Corporation |
| Jan 26, 2023 | Access Immunoassay Systems (1) Access 2 Immunoassay Analyzer (81600N); (2... | An increased incidence of damage to the nut band from a new vendor (Boamax) has led to an increas... | Class II | Beckman Coulter, Inc. |
| Jan 20, 2023 | SenSight Connector Plug, Model Number B31061. | Medtronic is requesting return of a small number of units of the SenSight Connector Plug, Model B... | Class II | Medtronic Neuromodulation |
| Jan 13, 2023 | Summit Medical Nasal Septal Button, Medium, 5cm, REF SP-78105, sterile. | Sterile product pouches were not sealed. | Class II | Summit Medical, LLC |
| Dec 16, 2022 | Mammotome MammoStar Biopsy Site Identified, REF STAR1401 | The label incorrectly identifies the product as STAR1401, a 1x3mm Barbell shaped marker pre-loade... | Class II | Carbon Medical Technologies, Inc. |
| Dec 12, 2022 | Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosur... | An upward trend of complaints in which the Temperature Monitoring Adapter (TMA), located on the A... | Class II | Medtronic Perfusion Systems |
| Dec 12, 2022 | Custom Pack Perfusion Tubing Packs containing Affinity Fusion Oxygenator with... | An upward trend of complaints in which the Temperature Monitoring Adapter (TMA), located on the A... | Class II | Medtronic Perfusion Systems |
| Dec 12, 2022 | Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosur... | An upward trend of complaints in which the Temperature Monitoring Adapter (TMA), located on the A... | Class II | Medtronic Perfusion Systems |
| Dec 12, 2022 | Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosur... | An upward trend of complaints in which the Temperature Monitoring Adapter (TMA), located on the A... | Class II | Medtronic Perfusion Systems |
| Dec 12, 2022 | Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosur... | An upward trend of complaints in which the Temperature Monitoring Adapter (TMA), located on the A... | Class II | Medtronic Perfusion Systems |
| Dec 12, 2022 | Custom Pack Perfusion Tubing Packs containing Affinity Fusion Oxygenator with... | An upward trend of complaints in which the Temperature Monitoring Adapter (TMA), located on the A... | Class II | Medtronic Perfusion Systems |
| Dec 9, 2022 | CADD Administration Set, List Numbers: a) REF 21-7308-24, b) REF 21-7309-24... | There are two potential issues with CADD Infusion System Infusion Sets: (1) Lack of Delivery or... | Class I | Smiths Medical ASD Inc. |
| Dec 9, 2022 | CADD Administration Set, List Numbers: a) REF 21-7600-24, b) REF 21-7609-24... | There are two potential issues with CADD Infusion System Infusion Sets: (1) Lack of Delivery or... | Class I | Smiths Medical ASD Inc. |
| Dec 9, 2022 | CADD Administration Set, List Numbers: 1) REF 21-7300-24, 2) REF 21-7301-24... | There are two potential issues with CADD Infusion System Infusion Sets: (1) Lack of Delivery or... | 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.