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DAYE (ANNE'S DAY LTD) recalls Initiation 3 Month Heavy Flow Bundle; Model Number: FG-BNDL-PC-MM-IBHF;
Recalled November 5, 2025 · FDA recall Z-0407-2026 · DAYE (ANNE'S DAY LTD)
Hazard
Product lacks 510(k) clearance. · FDA Class II
Units
3074 packs
Sold at
US Nationwide distribution.
Description
Product lacks 510(k) clearance.
Product
Initiation 3 Month Heavy Flow Bundle; Model Number: FG-BNDL-PC-MM-IBHF;
Manufacturer(s)
DAYE (ANNE'S DAY LTD)
Made in
United Kingdom
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →