Medtronic Xomed, Inc. Recalls

All product recalls associated with Medtronic Xomed, Inc..

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Recall Summary

Total Recalls

25

Past Year

2

Class I (Serious)

0

Most Recent

Jul 2025

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 1–20 of 25 recalls

IPC Powerease System (Medtronic) – Driver Wobble Issue (2025)

Due to out of the box wobble of the driver.

FDAJul 17, 2025AZ, CA, CO +22 more• Medtronic Xomed, Inc.

NIM Vital Nerve Monitor (Medtronic) – stimulus artifact (2025)

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.

FDAMar 10, 2025Nationwide• Medtronic Xomed, Inc.

ENT Cutting Bur (Medtronic Xomed) – Expired Distribution (2024)

Product was distributed past expiration date.

FDAJul 5, 2024Nationwide• Medtronic Xomed, Inc.

NIM Vital Nerve Monitoring System (Medtronic) – False Negative Risk (2024)

Potential for false negative response on the NIM Vital Nerve Monitoring System

FDAJun 24, 2024Nationwide• Medtronic Xomed, Inc.

Medtronic Xomed, Inc.: NIM TriVantage EMG Endotracheal Tubes, Model (REF) Number...

Firm received reports of customers experiencing noise from the NIM System, lead-off or high impedance issues, or loss of/intermittent nerve monitoring,

FDANov 7, 2023Nationwide• Medtronic Xomed, Inc.

Medtronic Xomed, Inc.: NIM Vital Console 4.0 (P/N: NIM4CM01) NIM with Software ...

Software anomaly was identified.

FDAMay 3, 2022Nationwide• Medtronic Xomed, Inc.

Medtronic Xomed, Inc.: NIM Vital Patient Interface 4.0 (P/N: NIM4CPB1) NIM with ...

Software anomaly was identified.

FDAMay 3, 2022Nationwide• Medtronic Xomed, Inc.

Medtronic Xomed, Inc.: NIM EMG Endotracheal Tube, Part Numbers: a) REF 8229308 b...

The firm received reports of events related to airway obstruction while using NIM Standard Reinforced EMG Endotracheal Tubes & NIM CONTACT Reinforced EMG Endotracheal Tubes.

FDAApr 29, 2022Nationwide• Medtronic Xomed, Inc.

Medtronic Xomed, Inc.: NIM CONTACT EMG Endotracheal Tube, Part Numbers: a) REF 8...

The firm received reports of events related to airway obstruction while using NIM Standard Reinforced EMG Endotracheal Tubes & NIM CONTACT Reinforced EMG Endotracheal Tubes.

FDAApr 29, 2022Nationwide• Medtronic Xomed, Inc.

Medtronic Xomed, Inc.: NIM TRIVANTAGE EMG Endotracheal Tube

There is potential for multiple issues due to a manufacturing nonconformity.

FDADec 22, 2021Nationwide• Medtronic Xomed, Inc.

Medtronic Xomed, Inc.: Software 1898072 IPC upgrade v 2.7.3.0, IPC System: a) CO...

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 the set number of rotations and the actual number of rotations in a specific mode when the product was used with our company's M5 handpiece.

FDADec 15, 2021Nationwide• Medtronic Xomed, Inc.

Medtronic Xomed, Inc.: Medtronic sterile single-use blades that are components o...

There was an increase in complaints related to tip breaks and wobble/vibration.

FDAAug 31, 2021Nationwide• Medtronic Xomed, Inc.

Medtronic Xomed, Inc.: Software 1898072 IPC upgrade v 2.7.3.0 - Product Usage: T...

Laceration Risk

During internal testing execution of the next generation of Integrated Power Console (IPC) prototype it was noted that the M5 Microdebrider was rotating at a higher speed than the set value in the cosole.

FDAJun 12, 2020Nationwide• Medtronic Xomed, Inc.

Medtronic Xomed, Inc.: Lamicel 20PK 5MM INTL

Routine sterilization dose does not meet the required Sterility Assurance Level.

FDANov 13, 2019IN• Medtronic Xomed, Inc.

Medtronic Xomed, Inc.: Lamicel 20PK 3MM INTL Cervical dilator

Routine sterilization dose does not meet the required Sterility Assurance Level.

FDANov 13, 2019IN• Medtronic Xomed, Inc.

Medtronic Xomed, Inc.: Lamicel 10PK 10MM INTL

Routine sterilization dose does not meet the required Sterility Assurance Level.

FDANov 13, 2019IN• Medtronic Xomed, Inc.

Medtronic Xomed, Inc.: Repose G2 Bone Screw System, Sterile, REF 76353200; Lot #...

Medtronic Xomed, Inc. is recalling the Repose Bone Screw System product and Bone Screw product due to improper labeling. The labeling for the Repose System was inadvertently placed on the Repose Screw and vice versa.

FDAJul 27, 2009Nationwide• Medtronic Xomed, Inc.

Medtronic Xomed, Inc.: Repose G2 Bone Screw, Sterile, REF 76310200, Lot # 62450...

Medtronic Xomed, Inc. is recalling the Repose Bone Screw System product and Bone Screw product due to improper labeling. The labeling for the Repose System was inadvertently placed on the Repose Screw and vice versa.

FDAJul 27, 2009Nationwide• Medtronic Xomed, Inc.

Medtronic Xomed, Inc.: Medtronic Integrated Power Console System, IP X1 REF 189...

An error code (Code 13) is displayed on some of the consoles when a Medtronic Stylus or EHS handpiece is connected to the IPC indicating that the handpiece has not been recognized by the console.

FDAJul 17, 2009Nationwide• Medtronic Xomed, Inc.

Medtronic Xomed, Inc.: VARI-STIM III Nerve Locator/Stimulator, Sterile, Medtroni...

Device may fail to operate or operate intermittently during use and such operation could result in a lack of nerve stimulation when nerve tissue is actually contacted by the stimulator.

FDANov 21, 2008Nationwide• Medtronic Xomed, Inc.

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Medtronic Xomed, Inc. Recalls

Recall Summary

IPC Powerease System (Medtronic) – Driver Wobble Issue (2025)

NIM Vital Nerve Monitor (Medtronic) – stimulus artifact (2025)

ENT Cutting Bur (Medtronic Xomed) – Expired Distribution (2024)

NIM Vital Nerve Monitoring System (Medtronic) – False Negative Risk (2024)

Medtronic Xomed, Inc.: NIM TriVantage EMG Endotracheal Tubes, Model (REF) Number...

Medtronic Xomed, Inc.: NIM Vital Console 4.0 (P/N: NIM4CM01) NIM with Software ...

Medtronic Xomed, Inc.: NIM Vital Patient Interface 4.0 (P/N: NIM4CPB1) NIM with ...

Medtronic Xomed, Inc.: NIM EMG Endotracheal Tube, Part Numbers: a) REF 8229308 b...

Medtronic Xomed, Inc.: NIM CONTACT EMG Endotracheal Tube, Part Numbers: a) REF 8...

Medtronic Xomed, Inc.: NIM TRIVANTAGE EMG Endotracheal Tube

Medtronic Xomed, Inc.: Software 1898072 IPC upgrade v 2.7.3.0, IPC System: a) CO...

Medtronic Xomed, Inc.: Medtronic sterile single-use blades that are components o...

Medtronic Xomed, Inc.: Software 1898072 IPC upgrade v 2.7.3.0 - Product Usage: T...

Medtronic Xomed, Inc.: Lamicel 20PK 5MM INTL

Medtronic Xomed, Inc.: Lamicel 20PK 3MM INTL Cervical dilator

Medtronic Xomed, Inc.: Lamicel 10PK 10MM INTL

Medtronic Xomed, Inc.: Repose G2 Bone Screw System, Sterile, REF 76353200; Lot #...

Medtronic Xomed, Inc.: Repose G2 Bone Screw, Sterile, REF 76310200, Lot # 62450...

Medtronic Xomed, Inc.: Medtronic Integrated Power Console System, IP X1 REF 189...

Medtronic Xomed, Inc.: VARI-STIM III Nerve Locator/Stimulator, Sterile, Medtroni...