FDA recall record · openFDA

Medtronic Xomed, Inc.

5 FDA recalls on record (2023–2025) — 5 device. 5 still ongoing.

Class I (most serious)

Class II

Class III

ongoing

How to read this. A recall count is not a quality verdict — large manufacturers recall more simply by volume, and a voluntary recall is the safety system working as intended. The signal to weight is the Class I count (the FDA's most-serious tier — reasonable probability of serious harm or death) and whether recalls are still ongoing. Most recalls are Class II/III. "Ongoing" reflects openFDA's last-published status — device recalls often stay marked ongoing long after they're resolved in practice; confirm current status at the FDA.

Most common reasons

Due to out of the box wobble of the driver. 1

Firm received reports of customers experiencing noise from the NIM System, lead-off or high impedance issues, or loss of 1

Product was distributed past expiration date. 1

Potential for false negative response on the NIM Vital Nerve Monitoring System 1

Nerve Monitoring System with certain software versions has potential for increased stimulus artifact, which may require 1

Recalls

NIM Vital Nerve Monitoring systems (all serial numbers manufactured) with NIM Vital System versions: v1.0.0, v1.1.1, v1. Class I 2024-06-24 IPC Powerease System REF 2300000 UDI-DI: 00613994448705 00643169406834. The IPC POWEREASE System is indicated for Class II 2025-07-17 NIM Vital Nerve Monitoring System: CONSOLE NIM4CM01 NIM 4.0, REF: NIM4CM01; CONSOLE NIM4CM01RF NIM 4.0 REFURBISHED, Class II 2025-03-10 Medtronic ENT Ultra Round Steel Cutting Bur, Model Number REF 31313069 Class II 2024-07-05 NIM TriVantage EMG Endotracheal Tubes, Model (REF) Numbers and sizes: a) 8229706, 6.0MM ID; b) 8229707, 7.0MM ID; c Class II 2023-11-07

RECORDED — these are the FDA's published recall enforcement records (openFDA). Recalls are listed under the exact firm name as filed; a large manufacturer may also file under name variants, so this may not be the company's complete cross-variant record — confirm at the FDA recall database. This page informs and routes; it is not medical advice or a verdict on the company.

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