---
title: "iotaSOFT Plus Drive Unit, REF IM-05. The iotaSOFT Insertion System is intende... — FDA record Z-0288-2025 | Is It on Recall"
description: "Incorrect GTIN number."
url: https://isitonrecall.com/recall/fda-device-z-0288-2025-iotasoft-plus-drive-unit-ref-im-05-the-iotasoft-insertion-system-is-intended-to-aid-the-surgeon-in-p/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement

# iotaSOFT Plus Drive Unit, REF IM-05. The iotaSOFT Insertion System is intended to aid the surgeon in placement of coc... — FDA record Z-0288-2025

Reported completed

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Sep 12, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **Product**: 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.
- **Reason**: Incorrect GTIN number.
- **Classification**: Class III
- **Recalling firm**: Iotamotion Inc
- **Quantity**: 5 devices
- **Agency-reported status**: Completed
- **Source record identifier**: Z-0288-2025

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0288-2025%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice.

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | Lot #D500330, EXP. 2025-01-12, UDI-DI 00850002960006 (the incorrect GTIN number listed on the label). |

Match all identifying details in the current notice. A brand name alone is not enough.

## Distribution

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

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

- [Iowa](https://isitonrecall.com/state/iowa/)

## Dates in the source

- **Report date**: Nov 13, 2024
- **Recall initiation date**: Sep 12, 2024
- **Center classification date**: Nov 1, 2024

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0288-2025%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [Iotamotion Inc records](https://isitonrecall.com/brand/iotamotion-inc/)