PlainRecalls
FDA Devices Moderate Class II Ongoing

18 Coated Regular Tampons; Model Number: FG-TMP-REF18000000;

Reported: November 5, 2025 Initiated: February 17, 2025 #Z-0381-2026

Product Description

18 Coated Regular Tampons; Model Number: FG-TMP-REF18000000;

Reason for Recall

Product lacks 510(k) clearance.

Details

Recalling Firm
DAYE (ANNE'S DAY LTD)
Units Affected
3074 packs
Distribution
US Nationwide distribution.
Location
London, N/A

Frequently Asked Questions

What product was recalled?
18 Coated Regular Tampons; Model Number: FG-TMP-REF18000000;. Recalled by DAYE (ANNE'S DAY LTD). Units affected: 3074 packs.
Why was this product recalled?
Product lacks 510(k) clearance.
Which agency issued this recall?
This recall was issued by the FDA Devices on November 5, 2025. Severity: Moderate. Recall number: Z-0381-2026.