[Recalled] Initiation 3 Month Regular Flow Bundle; Model Number: FG-BNDL-PC-MM-IBRF; — Product lacks 510(k) clearance | FDA 2025-02-17

Regulators flagged this product in an official safety action. Here is what the notice says and what it means for owners.

Recall details

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: Product lacks 510(k) clearance.

This Class II recall concerns device products distributed in United Kingdom and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.

What to do if you own this product

Check whether your unit is affected and follow the authority's guidance before further use.

Read the full official notice →

Related recalls from DAYE (ANNE'S DAY LTD)

• Refill 3 Month All in One Bundle; Model Number: FG-BNDL-PC-MM-REFAIO; — Class II
• Refill 18 Coated Regular and 18 Nude Regular Tampons; Model Number: FG-TMP-MM-REF18001800; — Class II
• 9 Coated Super Tampons and 9 Nude Super Tampons; Model Number: FG-TMP-RET00090009; — Class II
• Refill 3 Month Regular Flow Bundle; Model Number: FG-BNDL-PC-MM-REFRF; — Class II
• 18 Coated Regular Tampons; Model Number: FG-TMP-REF18000000; — Class II
• Initiation 36 Coated Regular Tampons; Model Number: FG-TMP-MM-IB36000000; — Class II

This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.