Recall database

Stimulator, Electrical, Evoked Response recalls

Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.

Showing 1–2 of 2 recalls

Class IIOngoingZ-2793-2026

Alphatec Spine, Inc. recalls SafeOp Patient Interface

Intraoperative neuromonitoring device, due to a software issue, may experience loss or interruption of triggered electromyography (tEMG) functionality during use, displaying as system faults, loss of communication betwee…

Evoked Response Electrical Stimulator
Software Design Change

Alphatec Spine, Inc.CAJul 29, 2026

Class IIOngoingZ-1623-2025

Medtronic Xomed, Inc. recalls NIM Vital Nerve Monitoring System: CONSOLE NIM4CM01 NIM 4.0

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.

Evoked Response Electrical Stimulator
Software change control

Medtronic Xomed, Inc.FLApr 30, 2025