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Browse Device Recalls

26 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 26 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 26 FDA device recalls.

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DateProductReasonClassFirm
Jul 17, 2025 IPC Powerease System REF 2300000 UDI-DI: 00613994448705 00643169406834. ... Due to out of the box wobble of the driver. Class II Medtronic Xomed, Inc.
Mar 10, 2025 NIM Vital Nerve Monitoring System: CONSOLE NIM4CM01 NIM 4.0, REF: NIM4CM01; ... Nerve Monitoring System with certain software versions has potential for increased stimulus artif... Class II Medtronic Xomed, Inc.
Jul 5, 2024 Medtronic ENT Ultra Round Steel Cutting Bur, Model Number REF 31313069 Product was distributed past expiration date. Class II Medtronic Xomed, Inc.
Jun 24, 2024 NIM Vital Nerve Monitoring systems (all serial numbers manufactured) with NIM... Potential for false negative response on the NIM Vital Nerve Monitoring System Class I Medtronic Xomed, Inc.
Nov 7, 2023 NIM TriVantage EMG Endotracheal Tubes, Model (REF) Numbers and sizes: a) 822... Firm received reports of customers experiencing noise from the NIM System, lead-off or high imped... Class II Medtronic Xomed, Inc.
May 3, 2022 NIM Vital Console 4.0 (P/N: NIM4CM01) NIM with Software version 1.3.2 Software anomaly was identified. Class II Medtronic Xomed, Inc.
May 3, 2022 NIM Vital Patient Interface 4.0 (P/N: NIM4CPB1) NIM with Software version 1.3.2 Software anomaly was identified. Class II Medtronic Xomed, Inc.
Apr 29, 2022 NIM EMG Endotracheal Tube, Part Numbers: a) REF 8229307J b) REF 8229308J ... The firm received reports of events related to airway obstruction while using NIM Standard Reinfo... Class I Medtronic Xomed, Inc.
Apr 29, 2022 NIM CONTACT EMG Endotracheal Tube, Part Numbers: a) REF 8229508 b) REF 8229... The firm received reports of events related to airway obstruction while using NIM Standard Reinfo... Class I Medtronic Xomed, Inc.
Apr 29, 2022 NIM EMG Endotracheal Tube, Part Numbers: a) REF 8229308 b) REF 8229307 c)... The firm received reports of events related to airway obstruction while using NIM Standard Reinfo... Class I Medtronic Xomed, Inc.
Dec 22, 2021 NIM TRIVANTAGE EMG Endotracheal Tube There is potential for multiple issues due to a manufacturing nonconformity. Class II Medtronic Xomed, Inc.
Dec 15, 2021 Software 1898072 IPC upgrade v 2.7.3.0, IPC System: a) CONSOLE 1898001 IPC, ... As a result of Medtronic's integrated power console (authentication number: 222ACBZX00018000) bei... Class II Medtronic Xomed, Inc.
Aug 31, 2021 Medtronic sterile single-use blades that are components of the StraightShot M... There was an increase in complaints related to tip breaks and wobble/vibration. Class II Medtronic Xomed, Inc.
Aug 31, 2021 Medtronic sterile single-use blades that are components of the StraightShot M... There was an increase in complaints related to tip breaks and wobble/vibration. Class II Medtronic Xomed, Inc.
Aug 31, 2021 Medtronic Sterile single-use blades that are components of the StraightShot M... There was an increase in complaints related to tip breaks and wobble/vibration. Class II Medtronic Xomed, Inc.
Jun 12, 2020 Software 1898072 IPC upgrade v 2.7.3.0 - Product Usage: The IPC system is ind... During internal testing execution of the next generation of Integrated Power Console (IPC) protot... Class II Medtronic Xomed, Inc.
Nov 13, 2019 Lamicel 20PK 3MM INTL Cervical dilator Routine sterilization dose does not meet the required Sterility Assurance Level. Class II Medtronic Xomed, Inc.
Nov 13, 2019 Lamicel 20PK 5MM INTL Routine sterilization dose does not meet the required Sterility Assurance Level. Class II Medtronic Xomed, Inc.
Nov 13, 2019 Lamicel 10PK 10MM INTL Routine sterilization dose does not meet the required Sterility Assurance Level. Class II Medtronic Xomed, Inc.
Jun 28, 2016 NIM EMG Endotracheal Tube, 6.0 mm I.D. x 8.8 mm O.D. (27 FR), Reinforced, St... Wire in tubing can become exposed, posing potential harm to the intubated patient. Class II Medtronic Xomed, Inc.
Aug 23, 2013 Universal Titanium Prosthesis, Round Head, with Flex H/A titanium shoe. The e... One lot of the product was assembled using the Cam Head version of the same prosthesis instead of... Class II Medtronic Xomed, Inc.
Jul 9, 2013 Tray Surgical, ENT (various instrument trays) Used for stot age and transp... The firm will recall and replace the identified instrument trays in the field, with trays that ha... Class II Medtronic Xomed, Inc.
Mar 4, 2013 REF 8229705 x1 NIM TriVantage EMG Endotracheal Tube 5.0 mm I.D. x 6.5 mm O.D.... In March 2013, Medtronic issued a recall of the NIM TriVantage EMG Endotracheal Tube due to cuff ... Class I Medtronic Xomed, Inc.
Sep 27, 2010 Interfaces subject to recall: Medtronic NIM (Nerve Integrity Monitor) 3.0 ... In January 2010, Medtronic issued a recall of Medtronic NIM 3.0 Patient Interfaces after Medtroni... Class II Medtronic Xomed, Inc.
Sep 27, 2010 Interfaces subject to recall: Medtronic NIM (Nerve Integrity Monitor) 3.0 ... In January 2010, Medtronic issued a recall of Medtronic NIM 3.0 Patient Interfaces after Medtroni... Class II Medtronic Xomed, Inc.
Sep 27, 2010 Interfaces subject to recall: Medtronic NIM (Nerve Integrity Monitor) 3.0 ... In January 2010, Medtronic issued a recall of Medtronic NIM 3.0 Patient Interfaces after Medtroni... Class II Medtronic Xomed, 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.