Iotamotion recalls iotaSOFT Plus Drive Unit (REF IM-05) due to incorrect GTIN number on label. This may cause misidentification of the product.
Incorrect GTIN number.
Iotamotion is recalling its iotaSOFT Plus Drive Unit (REF IM- 05) because it has an incorrect GTIN number on the label. This could lead to misidentification of the product, though the recall does not indicate a safety risk.
The product has an incorrect GTIN number on its label. This could lead to misidentification of the product, potentially causing confusion during medical procedures. However, the recall does not indicate a risk of injury or malfunction.
Surgeons who use the iotaSOFT Plus Drive Unit for cochlear implant procedures may be affected. The risk is low as the hazard involves labeling, not physical safety.
Check for the product name 'iotaSOFT Plus Drive Unit' with reference number IM-05. The label shows an incorrect GTIN number (UDI-DI 00850002960006).
Look for the incorrect GTIN number listed on the label (UDI-DI 00850002960006).
No, the recall is due to an incorrect GTIN number on the label, which may cause misidentification but does not pose a safety risk.
Check for the product name 'iotaSOFT Plus Drive Unit' with reference number IM-05 and the incorrect GTIN number (UDI-DI 00850002960006) on the label.
Check the label for the incorrect GTIN number. If you find it, contact Iotamotion for guidance.
We’ve drafted a message you can send Iotamotion to request your refund or repair — edit it as you like.
Subject: Recall Z-0288-2025 — Iotamotion Iotamotion Hello, I own a Iotamotion that is covered by recall Z-0288-2025 from Iotamotion. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
