Medical device recalls Moderate risk

DAYE (ANNE'S DAY LTD) recalls Refill 18 Coated Regular and 18 Nude Regular Tampons; Model Number: FG-TMP-MM-REF18001800;

Recall date
February 17, 2025
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0393-2026
FDA classification
Class II
Brand / firm
DAYE (ANNE'S DAY LTD)
Sold / distributed
US Nationwide distribution.

Why it was recalled

Product lacks 510(k) clearance.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Refill 18 Coated Regular and 18 Nude Regular Tampons; Model Number: FG-TMP-MM-REF18001800;

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