FDA Device recall Z-0770-2026
Continuous Glucose Monitor (CGM)
- FDA Device
- Class II
- ongoing
- Published 2025-12-10
On 2025-12-10 the FDA classified a Class II recall of Continuous Glucose Monitor (CGM) by Get Tested International Ab, citing distribution without premarket approval/clearance.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0770-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-11-03 |
| Published | 2025-12-10 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Get Tested International Ab |
| Distribution | US |
Product
Continuous Glucose Monitor (CGM)
Reason
Distribution without premarket approval/clearance.
Identifiers
| code_info | EAN: 7340221708952; SKU: CGM-15D; UDI-DI: None; Lot/Serial Number: All Lots; |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0770-2026%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.