Class II
Medical Device Recall: Refill 3 Month Regular Flow Bundle; Model Number: FG-BNDL-PC-MM-REFRF;
DAYE (ANNE'S DAY LTD) · February 17, 2025
Reason for Recall
Product lacks 510(k) clearance.
Distribution
US Nationwide distribution.
States Affected
NATIONWIDE
Quantity Affected
3074 packs
Source: FDA (openFDA Device Enforcement)
Recall number: Z-0397-2026
Status: ongoing
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.