CLASS III Device recall · Reported 13 Nov 2024 · FDA Enforcement Report
iotaSOFT Plus Drive Unit recalled by Iotamotion
Iotamotion is recalling iotaSOFT Plus Drive Unit, distributed in Iowa. The recall was initiated on 12 Sep 2024 and the FDA has classified it as Class III.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0288-2025
- FDA event ID
- 95462
- Recalling firm
- Iotamotion, Vadnais Heights, MN
- Classification
- Class III
- Status
- Completed
- Recall initiated
- 12 Sep 2024
- FDA classified
- 1 Nov 2024
- Reported
- 13 Nov 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Other
- Reason category
- Other Reasons
- Device type
- Imaging Equipment
Timeline
| 12 Sep 2024 | Recall initiated by company | |
| 1 Nov 2024 | Classified by FDA | +50 days |
| 13 Nov 2024 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Incorrect GTIN number.
Product as listed by the FDA
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.
Where it was distributed
Distribution was made to Iowa. There was no government/military/foreign distribution.
Questions about this recall
Is iotaSOFT Plus Drive Unit recalled?
Yes. Iotamotion recalled iotaSOFT Plus Drive Unit on 12 Sep 2024. The recall is Class III and its status is Completed. Recall number Z-0288-2025.
Why was it recalled?
Incorrect GTIN number.
Which lots are affected?
Lot #D500330, EXP. 2025-01-12, UDI-DI 00850002960006 (the incorrect GTIN number listed on the label).
Where was it sold?
Distribution was made to Iowa. There was no government/military/foreign distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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