FDA Medical devices recall ·
iotaSOFT Plus Drive Unit recall
- Recall number
- Z-0288-2025
- Date
- (initiated September 12, 2024)
- Company / brand
- Iotamotion Inc
4205 White Bear Pkwy Ste 600, Vadnais Heights, MN, United States - Category
- Medical devices › Class III
- Classification
- Class III
- Status
- Completed
- Units affected
- 5 devices
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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.
Why was it recalled?
Incorrect GTIN number.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot #D500330, EXP. 2025-01-12, UDI-DI 00850002960006 (the incorrect GTIN number listed on the label).
Distribution
Distribution was made to Iowa. There was no government/military/foreign distribution.
States: Iowa
What does Class III mean?
Class III means use of or exposure to the product is not likely to cause adverse health consequences (for example, a labeling violation).
Source: FDA (medical devices), recall Z-0288-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.