Medtronic Xomed recalls
10 official recalls and safety alerts involving Medtronic Xomed since 2021-10, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.
This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Medtronic Xomed or the relevant agency.
- 2025-09-03
USMedtronic Xomed, Inc. recalls IPC Powerease System REF 2300000 UDI-DI: 00613994448705 00643169406834. The IPC POWEREASE System is indicated for drilling, tapping, and…
Due to out of the box wobble of the driver.
FDA · DeviceMedtronic Xomed, Inc.U.S.: AZ, CA, CO, CT, FL, GA, IA, IL, IN, LA, MI, MN, MO, MS, NC, ND, NE, NJ,…Official notice →- 2025-04-30
- US
Medtronic Xomed, Inc. recalls NIM Vital Nerve Monitoring System: CONSOLE NIM4CM01 NIM 4.0, REF: NIM4CM01; CONSOLE NIM4CM01RF NIM 4.0 REFURBISHED, REF: NIM4CM01RF;…
Nerve Monitoring System with certain software versions has potential for increased stimulus artifact, which may require troubleshooting, and may lead to procedure delay, extubation, and medical intervention.
FDA · DeviceMedtronic Xomed, Inc.Worldwide - US Nationwide distribution including in the states of MD, MN, PA,…Official notice → - 2024-09-18
- US
Medtronic Xomed, Inc. recalls Medtronic ENT Ultra Round Steel Cutting Bur, Model Number REF 31313069
Product was distributed past expiration date.
FDA · DeviceMedtronic Xomed, Inc.International distribution to the country of Canada.Official notice → - 2024-07-31
- US
Medtronic Xomed, Inc. recalls NIM Vital Nerve Monitoring systems (all serial numbers manufactured) with NIM Vital System versions: v1.0.0, v1.1.1, v1.3.2, v1.4.3. NIM…
Potential for false negative response on the NIM Vital Nerve Monitoring System
FDA · DeviceMedtronic Xomed, Inc.Worldwide distribution - US Nationwide and the countries of Algeria,…Official notice → - 2024-01-17
- US
Medtronic Xomed, Inc. recalls NIM TriVantage EMG Endotracheal Tubes, Model (REF) Numbers and sizes: a) 8229706, 6.0MM ID; b) 8229707, 7.0MM ID; c) 8229708, 8.0MM ID; d)…
Firm received reports of customers experiencing noise from the NIM System, lead-off or high impedance issues, or loss of/intermittent nerve monitoring,
- 2022-09-07
- US
Medtronic Xomed, Inc. recalls NIM EMG Endotracheal Tube, Part Numbers: a) REF 8229308 b) REF 8229307 c) REF 8229306
The firm received reports of events related to airway obstruction while using NIM Standard Reinforced EMG Endotracheal Tubes & NIM CONTACT Reinforced EMG Endotracheal Tubes.
FDA · DeviceMedtronic Xomed, Inc.Worldwide distribution: US (nationwide) and OUS (foreign) countries of:…Official notice → - 2022-06-08
- US
Medtronic Xomed, Inc. recalls NIM Vital Patient Interface 4.0 (P/N: NIM4CPB1) NIM with Software version 1.3.2
Software anomaly was identified.
FDA · DeviceMedtronic Xomed, Inc.Worldwide distribution - US Nationwide distribution in the states of TX, CO,…Official notice → - 2022-04-27
- US
Medtronic Xomed, Inc. recalls Software 1898072 IPC upgrade v 2.7.3.0, IPC System: a) CONSOLE 1898001 IPC, Product Number 1898001; b) CONSOLE IPC REFURB, Product Number…
As a result of Medtronic's integrated power console (authentication number: 222ACBZX00018000) being used with software version: v2.7.3.0, it was discovered that there was a defect that resulted in a difference between…
- 2022-03-16
- US
Medtronic Xomed, Inc. recalls NIM TRIVANTAGE EMG Endotracheal Tube
There is potential for multiple issues due to a manufacturing nonconformity.
FDA · DeviceMedtronic Xomed, Inc.Worldwide distribution - US Nationwide and the countries of Algeria,…Official notice → - 2021-10-27
- US
Medtronic Xomed, Inc. recalls Medtronic Sterile single-use blades that are components of the StraightShot M Series Handpiece and Fusion ENT Navigation Software, and the…
There was an increase in complaints related to tip breaks and wobble/vibration.
FDA · DeviceMedtronic Xomed, Inc.Worldwide distribution - US Nationwide, including PR. There was also…Official notice →