CLASS II ONGOING Device recall · Reported 3 Aug 2022 · FDA Enforcement Report
etouchus, model no. Etm-G01. Noninvasive Blood glucose meter recalled
Touch US is recalling etouchus, model no. Etm-G01. Noninvasive Blood glucose meter, distributed nationwide in the US. The recall was initiated on 21 Jun 2022 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1461-2022
- FDA event ID
- 90523
- Recalling firm
- Touch US, Paramus, NJ
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 21 Jun 2022
- FDA classified
- 26 Jul 2022
- Reported
- 3 Aug 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Insulin Pumps & Glucose Monitors
Timeline
| 21 Jun 2022 | Recall initiated by company | |
| 26 Jul 2022 | Classified by FDA | +35 days |
| 3 Aug 2022 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Device was marketed without FDA 510(k) clearance or a PMA.
Product as listed by the FDA
etouchus, model no. ETM-G01. Noninvasive Blood glucose meter.
Where it was distributed
US Nationwide Distribution to: CA, FL IL KY LA MA MD MI NC NH NJ NY OH OK OR PA TN TX VA
Nationwide CaliforniaFloridaIllinoisKentuckyLouisianaMassachusettsMarylandMichiganNorth CarolinaNew HampshireNew JerseyNew YorkPennsylvaniaTennesseeTexasVirginia
Questions about this recall
Is etouchus, model no. Etm-G01. Noninvasive Blood glucose meter recalled?
Yes. Touch US recalled etouchus, model no. Etm-G01. Noninvasive Blood glucose meter on 21 Jun 2022. The recall is Class II and its status is Ongoing. Recall number Z-1461-2022.
Why was it recalled?
Device was marketed without FDA 510(k) clearance or a PMA.
Which lots are affected?
UDI-DI (GTIN): 00195893740581
Where was it sold?
US Nationwide Distribution to: CA, FL IL KY LA MA MD MI NC NH NJ NY OH OK OR PA TN TX VA
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other Insulin Pumps & Glucose Monitors recalls
All 459| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | MiniMed Insulin Pump recalled by Medtronic MiniMed | Medtronic MiniMed | Other | Nationwide |
| Device | CLASS II | MiniMed Insulin Pump recalled by Medtronic MiniMed | Medtronic MiniMed | Other | Nationwide |
| Device | CLASS II | MiniMed Insulin Pump recalled by Medtronic MiniMed | Medtronic MiniMed | Other | Nationwide |
| Device | CLASS II | MiniMed Insulin Pump recalled by Medtronic MiniMed | Medtronic MiniMed | Lead & Heavy Metals | Nationwide |
| Device | CLASS I | Omnipod (Eros) Pod recalled by Insulet | Insulet | Lead & Heavy Metals | Nationwide |