Recall Z-0387-2026— DAYE (ANNE'S DAY LTD)

Name: FDA recall Z-0387-2026
Creator: U.S. Food and Drug Administration
Published: 2025-02-17

Class II · Ongoing

Class II FDA medical device recall by DAYE (ANNE'S DAY LTD), initiated 2025-02-17. FDA's recall record names no specific 510(k) clearance for this event. Product: All in One Bundle; Model Number: FG-BNDL-PC-REFAIO;. Reason: Product lacks 510(k) clearance..

Recalling firm: DAYE (ANNE'S DAY LTD)
Classification: Class II
Status: Ongoing
Initiated: 2025-02-17
Firm location: London, N/A, United Kingdom

Product description

All in One Bundle; Model Number: FG-BNDL-PC-REFAIO;

Reason for recall

Product lacks 510(k) clearance.

Data sourced from openFDA. This site is unofficial and independent of the FDA.