iotaSOFT Plus Drive Unit Recalled Due to Incorrect GTIN Number
Iotamotion Inc. is recalling the iotaSOFT Plus Drive Unit (Lot #D500330) due to an incorrect GTIN number on the product label. Five devices were distributed in Iowa.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: FDA Class III device with a labeling error (incorrect GTIN number). No patient safety hazard or reported illnesses. Classified as a documentation issue per rubric guidelines for low-severity recalls.
Plain-English summary
Iotamotion Inc. is recalling the iotaSOFT Plus Drive Unit, Lot #D500330, a surgical instrument intended to aid surgeons in placing cochlear implant electrode arrays. The product is designed to control the speed of implant insertion, with an expiration date of January 12, 2025.
The product label contains an incorrect GTIN (Global Trade Item Number). This labeling error may affect product identification and inventory tracking.
Five devices were distributed to Iowa. Contact Iotamotion Inc. for instructions on addressing this recall.
The recalled product
- 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.
- Manufacturer
- Iotamotion Inc
- Hazard
- Affected units
- 5
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot #D500330
- EXP. 2025-01-12
- UDI-DI 00850002960006 (the incorrect GTIN number listed on the label).
Distribution
Distributed in 1 state:
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