Product Wiki · Recalls · U.S. FDA — Device Enforcement

Refill 3 Month Heavy Flow Bundle; Model Number: FG-BNDL-PC-MM-REFHF; — recall Z-0398-2026

U.S. FDA — Device Enforcement · United Kingdom · 2025-02-17 · Class II

As described by U.S. FDA — Device Enforcement: Refill 3 Month Heavy Flow Bundle; Model Number: FG-BNDL-PC-MM-REFHF;

Compiled from an official source — the facts on this page are reproduced from the issuing authority’s own published notice, which is linked above. No AI-generated text appears on this page. How we use AI →
Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0398-2026
Date of alert
2025-02-17
Country / jurisdiction
United Kingdom
Risk level
Class II
Risk type
recall
Brand
DAYE (ANNE'S DAY LTD)
Product category
device
Product type
Devices
Recall status
Ongoing — the recall is still in progress
Initiated by
Voluntary: Firm initiated
Distribution
US Nationwide distribution.
Barcode (EAN/GTIN)
5060994741629
Reported risk: Product lacks 510(k) clearance.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.