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.

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DateProductReasonClassFirm
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.
Dec 9, 2022 CADD Administration Set, List Numbers: a) REF 21-7346-24; b) REF 21-7363-24 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.
Dec 3, 2022 Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems ... Software anomalies, CP App messages: "Too Many Device Found", "Unexpected Device Error Code 1502... Class II Medtronic Neuromodulation
Dec 3, 2022 Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems ... Software anomalies, CP App messages: "Too Many Device Found", "Unexpected Device Error Code 1502... Class II Medtronic Neuromodulation
Dec 3, 2022 Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems ... Software anomalies, CP App messages: "Too Many Device Found", "Unexpected Device Error Code 1502... Class II Medtronic Neuromodulation
Dec 3, 2022 Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems ... Software anomalies, CP App messages: "Too Many Device Found", "Unexpected Device Error Code 1502... Class II Medtronic Neuromodulation
Dec 3, 2022 Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems ... Software anomalies, CP App messages: "Too Many Device Found", "Unexpected Device Error Code 1502... Class II Medtronic Neuromodulation
Nov 30, 2022 ActiveAid 922, Shower/Commode Chair Device manufactured with a component with affects the foldability of the frame, not allowing it t... Class II Altimate Medical, Inc.
Nov 23, 2022 COVIDIEN Emprint Ablation Catheter with Thermosphere Technology, Bronchoscopi... The product is labeled with the incorrect expiration date. Class II Covidien, LLC
Nov 7, 2022 R&D CBC-3D Hematology Control: (1) CBC-3D Normal Pack Hematology Control, ... For one lot of CBC-3D Hematology Control, the Normal Level may exhibit hemolysis or deterioration... Class III R & D Systems, Inc.
Oct 13, 2022 EKOS Control Unit 4.0 console, a component of the EKOS Control System 4.0, wh... Consoles were shipped without an instruction for use (IFU) or with the incorrect IFU. Class II Boston Scientific Corporation
Oct 10, 2022 Medfusion Model 4000 Syringe Infusion Pump, with software versions V1.6.0 or ... Potential for delay in sending Infusion Start Messages to third-party Electronic Health Record sy... Class II Smiths Medical ASD Inc.
Oct 6, 2022 3M Steri-Drape, Small Towel Drape, REF 1000, general surgery drape During a recent investigation, 3M confirmed the liner on the adhesive component of the affected d... Class II 3M Healthcare Business
Oct 6, 2022 3M Steri-Drape, Small Drape with Adhesive Aperture, REF 1020NS, general surge... During a recent investigation, 3M confirmed the liner on the adhesive component of the affected d... Class II 3M Healthcare Business
Oct 6, 2022 3M Steri-Drape, Medium Drape with Incise Film and Pouch, REF 1061, general su... During a recent investigation, 3M confirmed the liner on the adhesive component of the affected d... Class II 3M Healthcare Business
Oct 6, 2022 3M Steri-Drape, Medium Drape with Incise Film and Pouch, REF 1061NS, general ... During a recent investigation, 3M confirmed the liner on the adhesive component of the affected d... Class II 3M Healthcare Business
Oct 6, 2022 3M Steri-Drape, Medium Drape with Adhesive Aperture, REF 1030, general surger... During a recent investigation, 3M confirmed the liner on the adhesive component of the affected d... Class II 3M Healthcare Business
Oct 6, 2022 3M Steri-Drape, Small Drape with Incise Film, REF 1021, general surgery drape During a recent investigation, 3M confirmed the liner on the adhesive component of the affected d... Class II 3M Healthcare Business
Oct 6, 2022 3M Steri-Drape, Small Towel Drape, REF 1000NS, general surgery drape During a recent investigation, 3M confirmed the liner on the adhesive component of the affected d... Class II 3M Healthcare Business
Oct 6, 2022 3M Steri-Drape, Small Drape with Incise Film, REF 1021NS, general surgery drape During a recent investigation, 3M confirmed the liner on the adhesive component of the affected d... Class II 3M Healthcare Business
Oct 6, 2022 3M Steri-Drape, Medium Drape with Incise Film, REF 1060NS, general surgery d... During a recent investigation, 3M confirmed the liner on the adhesive component of the affected d... Class II 3M Healthcare Business
Oct 6, 2022 3M Steri-Drape, Large Towel Drape, REF 1010NS, general surgery drape During a recent investigation, 3M confirmed the liner on the adhesive component of the affected d... Class II 3M Healthcare Business
Oct 6, 2022 3M Steri-Drape, Medium Drape with Adhesive Aperture, REF 1030NS, general surg... During a recent investigation, 3M confirmed the liner on the adhesive component of the affected d... Class II 3M Healthcare Business
Oct 6, 2022 3M Steri-Drape, Medium Drape with Wide Adhesive Aperture, REF 1033, general s... During a recent investigation, 3M confirmed the liner on the adhesive component of the affected d... Class II 3M Healthcare Business
Oct 6, 2022 3M Steri-Drape, Large Towel Drape, REF 1010NSD, general surgery drape During a recent investigation, 3M confirmed the liner on the adhesive component of the affected d... Class II 3M Healthcare Business
Oct 6, 2022 3M Steri-Drape, Urological Drape, REF 1071, general surgery (urology) drape During a recent investigation, 3M confirmed the liner on the adhesive component of the affected d... Class II 3M Healthcare Business
Oct 6, 2022 3M Steri-Drape, Small Towel Drape, REF 1000NSD, general surgery drape During a recent investigation, 3M confirmed the liner on the adhesive component of the affected d... Class II 3M Healthcare Business
Oct 6, 2022 3M Steri-Drape, Medium Drape with Incise Film, REF 1060, general surgery drape During a recent investigation, 3M confirmed the liner on the adhesive component of the affected d... Class II 3M Healthcare Business

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.