Iotamotion Inc: Medical Device Recall in 2024 - (Recall #: Z-0288-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

iotaSOFT Plus Drive Unit, REF IM-05. The iotaSOFT Insertion System is intended to aid the surgeon in placement of cochlear implant electrode arrays into a radiographically normal cochlea by controlling the speed of implant insertion.

Product Classification:

Class III

Date Initiated: September 12, 2024

Date Posted: November 13, 2024

Recall Number: Z-0288-2025

Event ID: 95462

Reason for Recall:

Incorrect GTIN number.

Status: Completed

Product Quantity: 5 devices

Code Information:

Lot #D500330, EXP. 2025-01-12, UDI-DI 00850002960006 (the incorrect GTIN number listed on the label).

Distribution Pattern:

Distribution was made to Iowa. There was no government/military/foreign distribution.

Voluntary or Mandated:

Voluntary: Firm initiated