# FDA recall Z-0403-2026

> **DAYE (ANNE'S DAY LTD)** · Class II · device recall initiated 2025-02-17.

## Product

Initiation 18 Coated Super and 18 Nude Super Tampons;  Model Number: FG-TMP-MM-IB00180018;

## Reason for recall

Product lacks 510(k) clearance.

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-0403-2026
- **Recalling firm:** DAYE (ANNE'S DAY LTD)
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-02-17
- **Report date:** 2025-11-05

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** London, N/A, United Kingdom

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0403-2026

## Citation

> AI Analytics. FDA recall Z-0403-2026. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-0403-2026. Source: US FDA. Licensed CC0.

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