The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1461-2022·Announced 2022-08-03

Blood Glucose Meter Recalled for Marketing Without FDA Clearance

Touch US Llc recalled 149 etouchus blood glucose meters (model ETM-G01) because they were marketed without FDA 510(k) clearance or approval. The device was distributed nationwide.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a FDA Class II device marketed without required 510(k) clearance, which represents a regulatory violation and risk-of-harm product. No illnesses or injuries have been reported, placing it at the maximum score for unverified medical devices.

Plain-English summary

Touch US Llc is recalling the etouchus blood glucose meter (model ETM-G01) that were sold to consumers across the United States. The recall involves 149 units that were distributed nationwide to customers in California, Florida, Illinois, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, North Carolina, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, and Virginia.

The device is being recalled because it was marketed in the United States without FDA 510(k) clearance or approval. Medical devices of this type require premarket FDA approval to ensure safety and effectiveness before being made available to consumers.

This is a medical device intended for blood glucose monitoring, which is used to make health decisions by patients with diabetes. Because the device was not reviewed and cleared by the FDA, there is potential risk that it may not perform as intended or may not meet safety standards.

Consumers who own this device should contact Touch US Llc for instructions on return or disposal. Patients should consult with their healthcare provider about alternative approved devices for blood glucose monitoring.

The recalled product

Product
etouchus, model no. ETM-G01. Noninvasive Blood glucose meter.
Manufacturer
Touch US Llc
Category
Medical Device — Blood Glucose Meter
Hazard
Affected units
149

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • UDI-DI (GTIN): 00195893740581

Distribution

Distributed nationwide across the United States.

The notice also names 19 states specifically:

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