Low risk — use of or exposure to this product is not likely to cause adverse health consequences.
iotaSOFT Plus Drive Unit Recalled by Iotamotion Inc Due to Incorrect GTIN number.
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Iotamotion Inc directly.
Affected Products
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.
Quantity: 5 devices
Why Was This Recalled?
Incorrect GTIN number.
Where Was This Sold?
Distribution was made to Iowa. There was no government/military/foreign distribution.
About Iotamotion Inc
Iotamotion Inc has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report