FDA recall Z-0396-2026
DAYE (ANNE'S DAY LTD) · Class II · device
Product
Refill 3 Month All in One Bundle; Model Number: FG-BNDL-PC-MM-REFAIO;
Reason for recall
Product lacks 510(k) clearance.
Distribution
US Nationwide distribution.
Key facts
- Status
- Ongoing
- Initiation date
- 2025-02-17
- Report date
- 2025-11-05
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- London, N/A, United Kingdom
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0396-2026