FDA Device recall Z-1461-2022
etouchus, model no
- FDA Device
- Class II
- ongoing
- Published 2022-08-03
On 2022-08-03 the FDA classified a Class II recall of etouchus, model no by Touch Us, citing device was marketed without FDA 510(k) clearance or a PMA.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1461-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-06-21 |
| Published | 2022-08-03 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Touch Us |
| Distribution | US |
Product
etouchus, model no. ETM-G01. Noninvasive Blood glucose meter.
Reason
Device was marketed without FDA 510(k) clearance or a PMA.
Identifiers
| code_info | UDI-DI (GTIN): 00195893740581 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1461-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.