etouchus recall
etouchus, model no. ETM-G01. Noninvasive Blood glucose meter.
Why was etouchus recalled?
Device was marketed without FDA 510(k) clearance or a PMA.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI-DI (GTIN): 00195893740581
- Product
- etouchus, model no. ETM-G01. Noninvasive Blood glucose meter.
- Recalling firm
- Touch US Llc
- Quantity
- 149
- Distribution
- US Nationwide Distribution to: CA, FL IL KY LA MA MD MI NC NH NJ NY OH OK OR PA TN TX VA
- Recall date
- August 3, 2022
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)