Continuous Glucose Monitor recall
Continuous Glucose Monitor (CGM)
Why was Continuous Glucose Monitor recalled?
Distribution without premarket approval/clearance.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
EAN: 7340221708952; SKU: CGM-15D; UDI-DI: None; Lot/Serial Number: All Lots;
- Product
- Continuous Glucose Monitor (CGM)
- Recalling firm
- GET TESTED INTERNATIONAL AB
- Quantity
- 4 units
- Distribution
- US Nationwide distribution.
- Recall date
- December 10, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)