Medtronic Xomed, Inc. recalls
Every recall we track for Medtronic Xomed, Inc. — 19 in all, from 2019–2025 — plus the complaints and injury reports the public filed about them.
Recalls per year, by danger level
19 recalls since 2017.
All FDA recall records for Medtronic Xomed, Inc. since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 0 | 0 | 3 | 0 | 3 |
| 2020 | 0 | 1 | 0 | 0 | 1 |
| 2021 | 0 | 3 | 1 | 1 | 5 |
| 2022 | 0 | 3 | 0 | 2 | 5 |
| 2023 | 0 | 0 | 1 | 0 | 1 |
| 2024 | 0 | 0 | 2 | 0 | 2 |
| 2025 | 0 | 0 | 2 | 0 | 2 |
| 2026 (to date) | 0 | 0 | 0 | 0 | 0 |
Most common reasons for Medtronic Xomed, Inc. recalls
What to do if you have a recalled Medtronic Xomed, Inc. product
- Match the model, catalog or lot number on your device to the recall.
- Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals.
- Report problems to FDA MedWatch.
All Medtronic Xomed, Inc. recalls
12 shown- Lower riskMedical device
Medtronic Xomed, Inc. recalls IPC Powerease System REF 2300000 UDI-DI: 00613994448705 00643169406834. The IPC POWEREASE System is indicated for
Recall of Medtronic Xomed IPC POWEREASE System with out-of-box wobble risk during spinal surgery. Affected units have specific serial numbers and UDI-DI codes.
Medtronic XomedJul 17, 2025 - Lower riskMedical device
Medtronic Xomed, Inc. recalls NIM Vital Nerve Monitoring System: CONSOLE NIM4CM01 NIM 4.0, REF: NIM4CM01; CONSOLE NIM4CM01RF NIM 4.0 REFURBISHED,
Medtronic Xomed recalls NIM Vital Nerve Monitoring Systems with software versions v1.6.4 or earlier due to potential increased nerve monitoring artifacts, which may cause procedure delays and medical interventions.
Medtronic XomedMar 10, 2025 - Lower riskMedical device
Medtronic Xomed, Inc. recalls Medtronic ENT Ultra Round Steel Cutting Bur, Model Number REF 31313069
Medtronic recalls Ultra Round Steel Cutting Bur (REF 31313069) due to distribution past expiration date. Consumers should check product details and contact Medtronic for guidance.
MedtronicJul 5, 2024 - Lower riskMedical device
Medtronic Xomed, Inc. recalls NIM Vital Nerve Monitoring systems (all serial numbers manufactured) with NIM Vital System versions: v1.0.0, v1.1.1,
Recalled NIM Vital Nerve Monitoring systems (all serial numbers manufactured) with specific software versions v1.0.0, v1.1.1, v1.3.2, v1.4.3 may show false negative responses. Consumers should check their product details.
Medtronic XomedJun 24, 2024 - Lower riskMedical device
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)
Medtronic Xomed recalls specific models of NIM TriVantage EMG Endotracheal Tubes (6.0MM ID, 7.0MM ID, 8.0MM ID) due to reported noise, lead-off or high impedance issues, and intermittent nerve monitoring problems.
Medtronic XomedNov 7, 2023 - UnratedMedical device
Medtronic Xomed, Inc. recalls NIM Vital Patient Interface 4.0 (P/N: NIM4CPB1) NIM with Software version 1.3.2
Medtronic Xomed recalls NIM Vital Patient Interface 4.0 with software version 1.3.2 due to a software anomaly. Affected units have specific model numbers and lot numbers listed in the recall notice.
Medtronic XomedMay 3, 2022 - Use cautionMedical device
Medtronic Xomed, Inc. recalls NIM EMG Endotracheal Tube, Part Numbers: a) REF 8229308 b) REF 8229307 c) REF 8229306
Medtronic Xomed recalls NIM EMG Endotracheal Tubes with specific part numbers due to reported airway obstruction risks during use. Affected units include models REF 8229306-8229308.
Medtronic XomedApr 29, 2022 - UnratedMedical device
Medtronic Xomed, Inc. recalls NIM TRIVANTAGE EMG Endotracheal Tube
Medtronic Xomed recalls specific NIM TRIVANTAGE EMG Endotracheal Tube models with certain product numbers and lots due to a manufacturing nonconformity that may cause multiple issues.
Medtronic XomedDec 22, 2021 - Lower riskMedical device
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
Medtronic Xomed recalls specific IPC console software versions that may cause incorrect rotation counts when used with M5 handpieces. Affected units include certain console models with product numbers 1898001, EC300RF, and EC300. No immediate action is required as the hazard is a minor software discrepancy.
Medtronic XomedDec 15, 2021 - Use cautionMedical device
Medtronic Xomed, Inc. recalls Medtronic Sterile single-use blades that are components of the StraightShot M Series Handpiece and Fusion ENT
Medtronic recalls sterile single-use blades for StraightShot M Series Handpiece and Fusion ENT systems due to increased tip breaks and wobble/vibration complaints. Affected product numbers and serials listed.
MedtronicAug 31, 2021 - Use cautionMedical device
Medtronic Xomed, Inc. recalls Software 1898072 IPC upgrade v 2.7.3.0 - Product Usage: The IPC system is indicated for the incision/cutting removal,
Medtronic Xomed recalls specific IPC software versions due to potential M5 Microdebrider rotating at higher speed than set during surgical procedures. Affected units include model 1898072 with listed lot numbers.
Medtronic XomedJun 12, 2020 - Lower riskMedical device
Medtronic Xomed, Inc. recalls Lamicel 10PK 10MM INTL
Medtronic Xomed recalls Lamicel 10PK 10MM INTL due to inadequate sterilization. Affected units have specific UDI and lot numbers. Consumers should contact for details.
Medtronic XomedNov 13, 2019
Medtronic Xomed, Inc. recall questions
How many recalls has Medtronic Xomed, Inc. had?
19 recalls from Medtronic Xomed, Inc. are on record with U.S. safety agencies, from 2019–2025.
What is the most recent Medtronic Xomed, Inc. recall?
Medtronic Xomed, Inc. recalls IPC Powerease System REF 2300000 UDI-DI: 00613994448705 00643169406834. The IPC POWEREASE System is indicated for, dated Jul 17, 2025. Every Medtronic Xomed, Inc. recall is listed on this page, newest first.
Why are Medtronic Xomed, Inc. products recalled?
The most common reasons on record: Routine sterilization dose does not meet the required Sterility Assurance Level. (3); There was an increase in complaints related to tip breaks and wobble/vibration. (3); Software anomaly was identified. (2).
What should I do if I have a recalled Medtronic Xomed, Inc. product?
Match the model, catalog or lot number on your device to the recall. Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals. Report problems to FDA MedWatch.
How do I get alerts for new Medtronic Xomed, Inc. recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.