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Open, Classified

etouchus, model no. ETM-G01. Noninvasive Blood glucose meter.

FDA Recall Z-1461-2022 · Posted None

Recalling FirmTouch US Llc
Recall StatusOpen, Classified
Product CodeNBW
Date Initiated2022-06-21
Product Quantity149

Reason for Recall

Device was marketed without FDA 510(k) clearance or a PMA.

Firm Action

On June 21, 2022, the firm communicated the recall to customers who purchased the product through the company's website. The firm is also making an effort to recall the product that was sold through Amazon Marketplace. Customers should return any affected product to eTouch US LLC. The firm will provide a full refund of the original purchase cost to the customer when the recalled device is received from the customer. If you have any questions, please contact the firm Monday thru Friday, 9AM - 5PM Eastern Time: Support Team: 888-670-9070 Email: [email protected]

Root Cause

No Marketing Application

Distribution Pattern

US Nationwide Distribution to: CA, FL IL KY LA MA MD MI NC NH NJ NY OH OK OR PA TN TX VA

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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