9 Coated Regular Tampons and 9 Nude Regular Tampons — Class II medical device recall Z-0380-2026
Ongoing recall by DAYE (ANNE'S DAY LTD), reported 2025-11-05, distributed nationwide. Product lacks 510(k) clearance.
| Recall number | Z-0380-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | DAYE (ANNE'S DAY LTD), London, N/A, United Kingdom |
| Recall initiated | 2025-02-17 |
| Classified | 2025-10-28 |
| Reported by FDA | 2025-11-05 |
| Distributed | Nationwide (US) |
| Quantity | 3,074 packages |
| UPC / GTIN / UDI-DI | 05060994740592 |
| Lot numbers | 20CR0014, 20CS0034, 20CS0037, 20CS0038, 20CS0039, 20CS0040, 20CS0041, CR001597, CR001598, CR001599, CR001615, CR001616, CR001616CS002164, CR001616NR001893, CR001617, CR001617CS002165, CR001617NR001902, CR001619, CR001623, CR001625, CR001626, CR001627, CR001629, CR001633, CR001636, CR001638, CR001640, CR001643, CR001645, CR001655, CR001655CS002196, CR001661, CR001661NR002015, CR001662, CR003000, CR003000NR002173, CR003001, CR003002, CR003005, CR003008 and 46 more |
| Model numbers | FG-TMP-RET09000900 |
Product
9 Coated Regular Tampons and 9 Nude Regular Tampons; Model Number: FG-TMP-RET09000900;
Reason for recall
Product lacks 510(k) clearance.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0380-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.