Touch US recalls noninvasive blood glucose meter model ETM-G01 due to lack of FDA clearance. Affected units sold without proper regulatory approval.
Device was marketed without FDA 510(k) clearance or a PMA.
Touch US is recalling its noninvasive blood glucose meter (model ETM-G01) because it was sold without FDA clearance. This means the device may not be safe for medical use.
The device was marketed without FDA clearance, meaning it hasn't been proven safe or effective for medical use. Without proper regulatory approval, there's a risk of inaccurate readings or health complications.
People who own or use the Touch US ETM-G01 blood glucose meter are affected. Those with diabetes who rely on this device for monitoring are at higher risk.
Check for the model number ETM-G01 on the device. The device has a unique identifier (GTIN): 00195893740581.
Look for the model number ETM-G01 on the device or its packaging.
The recall record states the device was marketed without FDA clearance, so it may not be safe for medical use.
Check for the model number ETM-G01 and the unique identifier (GTIN): 00195893740581.
The recall record does not specify a remedy, so contact Touch US directly for guidance.
We’ve drafted a message you can send Touch US to request your refund or repair — edit it as you like.
Subject: Recall Z-1461-2022 — Touch US Touch US Hello, I own a Touch US that is covered by recall Z-1461-2022 from Touch US. 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.
