Drug recall
etouchus, model no. ETM-G01. Noninvasive Blood glucose meter.
FDA recall event 90523 · Class II · Touch US Llc
Key facts
| Event ID | 90523 |
|---|---|
| Recall numbers | Z-1461-2022 |
| Recalling firm | Touch US Llc |
| Product type | Devices |
| Products | etouchus, model no. ETM-G01. Noninvasive Blood glucose meter. |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Device was marketed without FDA 510(k) clearance or a PMA. |
| Initiation date | Jun 21, 2022 |
| Report date | Aug 3, 2022 |
| City | Paramus |
| State | NJ |
| Country | United States |
| FEI number | 3023066634 |
At a glance
- 1–9 Products in this recall
- None FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: