9 Coated Super and 9 Nude Super Tampons; Model Number: FG-TMP-REF00090009;
Reported: November 5, 2025 Initiated: February 17, 2025 #Z-0385-2026
Product Description
9 Coated Super and 9 Nude Super Tampons; Model Number: FG-TMP-REF00090009;
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? ▼
9 Coated Super and 9 Nude Super Tampons; Model Number: FG-TMP-REF00090009;. 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-0385-2026.
Related Recalls
FDA Devices Moderate
Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.2…
Vortex Surgical Inc. · 2026-02-11
FDA Devices Moderate
COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conju…
Beckman Coulter, Inc. · 2026-02-11
FDA Devices Moderate
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 Product Description: These inst…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0330 Product Description: These in…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not Applicable Produc…
Fujirebio Diagnostics, Inc. · 2026-02-11