Z-1461-2022Class II

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

Name: Z-1461-2022 etouchus, model no. ETM-G01. Noninvasive Blood glucose meter
Creator: Touch US Llc
Published: 2022-06-21
License: https://open.fda.gov/license/

Touch US LLC / initiated 2022-06-21 / Open, Classified

FDA source

Touch US Llc began a recall of etouchus, model no. ETM-G01. Noninvasive Blood glucose meter on 2022-06-21. FDA classified it as Class II and gives the reason as "Device was marketed without FDA 510(k) clearance or a PMA". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1461-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-06-21
Posted: 2022-07-26
Recalling firm: Touch US LLC
Product: etouchus, model no. ETM-G01. Noninvasive Blood glucose meter.
Product code: NBW System, Test, Blood Glucose, Over The Counter
Reason for recall: Device was marketed without FDA 510(k) clearance or a PMA.
FDA root cause: No Marketing Application
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]
Quantity in commerce: 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
Product codes and lots: UDI-DI (GTIN): 00195893740581

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1461-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1461-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-08-03	2022-07-26

Product code NBW

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)