CGM Recall: GET TESTED CGM-15D
Announced 2025-12-10 · FDA
FDA recall involves four Continuous Glucose Monitor units distributed nationwide in the United States by GET TESTED INTERNATIONAL AB. The recall is due to distribution without premarket approval or clearance. All lots are affected (SKU CGM-15D; EAN 7340221708952) and no corrective action is listed.
| Brand | GET TESTED INTERNATIONAL AB |
|---|---|
| Product | Continuous Glucose Monitor (CGM) |
| Reason | Distribution without premarket approval/clearance. |
| Severity | moderate |
| Units affected | 5 |
| Distribution | US Nationwide distribution. |
| Agency | FDA |
WHAT YOU SHOULD DO
- Do not use any recalled CGM units and remove them from service.
- Contact GET TESTED INTERNATIONAL AB for instructions on return, disposal, or replacement.
- Monitor FDA updates for recall status and follow any additional guidance.
How to identify the recalled item
| Lot / date codes | EAN: 7340221708952; SKU: CGM-15D; UDI-DI: None; Lot/Serial Number: All Lots; |
|---|---|
| Lot / date codes | EAN: 616612785626; SKU: 1G1; UDI-DI: None; Lot/Serial Number: All Lots; |
These are the identifiers FDA published for this recall. Most recall notices list no UPC or model number at all — if the code on your item is not shown here, that does not mean the item is excluded. Check the official notice, or contact the company.
This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.