# FDA recall Z-0288-2025

> **Iotamotion Inc** · Class III · device recall initiated 2024-09-12.

## 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 for recall

Incorrect GTIN number.

## Distribution

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

## Key facts

- **Recall number:** Z-0288-2025
- **Recalling firm:** Iotamotion Inc
- **Classification:** Class III
- **Product type:** device
- **Status:** Completed
- **Initiation date:** 2024-09-12
- **Report date:** 2024-11-13

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Vadnais Heights, MN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0288-2025

## Citation

> AI Analytics. FDA recall Z-0288-2025. Retrieved 2026-07-16 from https://api.ai-analytics.org/recall/Z-0288-2025. Source: US FDA. Licensed CC0.

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