Drug & Device Safety Atlas

FDA recall record · openFDA

DAYE (ANNE'S DAY LTD)

29 FDA recalls on record (2025) — 29 device. 29 still ongoing.

0
Class I (most serious)
29
Class II
0
Class III
29
ongoing

How to read this. A recall count is not a quality verdict — large manufacturers recall more simply by volume, and a voluntary recall is the safety system working as intended. The signal to weight is the Class I count (the FDA's most-serious tier — reasonable probability of serious harm or death) and whether recalls are still ongoing. Most recalls are Class II/III. "Ongoing" reflects openFDA's last-published status — device recalls often stay marked ongoing long after they're resolved in practice; confirm current status at the FDA.

Most common reasons

Product lacks 510(k) clearance. 29

Recalls

Refill 3 Month All in One Bundle; Model Number: FG-BNDL-PC-MM-REFAIO; Class II 2025-02-17 Refill 18 Coated Regular and 18 Nude Regular Tampons; Model Number: FG-TMP-MM-REF18001800; Class II 2025-02-17 9 Coated Super Tampons and 9 Nude Super Tampons; Model Number: FG-TMP-RET00090009; Class II 2025-02-17 Refill 3 Month Regular Flow Bundle; Model Number: FG-BNDL-PC-MM-REFRF; Class II 2025-02-17 18 Coated Regular Tampons; Model Number: FG-TMP-REF18000000; Class II 2025-02-17 Initiation 36 Coated Regular Tampons; Model Number: FG-TMP-MM-IB36000000; Class II 2025-02-17 9 Coated Super and 9 Nude Super Tampons; Model Number: FG-TMP-REF00090009; Class II 2025-02-17 Initiation 3 Month Trial Tampon Box; Model Number: FG-TMP-MM-IB09090909; Class II 2025-02-17 Initiation 3 Month All in One Bundle; Model Number: FG-BNDL-PC-MM-IBAIO; Class II 2025-02-17 Initiation 36 Coated Super Tampons; Model Number: FG-TMP-MM-IB00360000; Class II 2025-02-17 Trial Tampon Box; Model Number: FG-TMP-REF04050504; Class II 2025-02-17 Initiation 3 Month Regular Flow Bundle; Model Number: FG-BNDL-PC-MM-IBRF; Class II 2025-02-17 Heavy Flow Bundle; Model Number: FG-BNDL-PC-REFHF; Class II 2025-02-17 Refill 18 Coated Super and 18 Nude Super Tampons; Model Number: FG-TMP-MM-REF00180018; Class II 2025-02-17 Refill 3 Month Heavy Flow Bundle; Model Number: FG-BNDL-PC-MM-REFHF; Class II 2025-02-17 Refill 36 Coated Super Tampons; Model Number: FG-TMP-MM-REF00360000; Class II 2025-02-17 Initiation 3 Month Heavy Flow Bundle; Model Number: FG-BNDL-PC-MM-IBHF; Class II 2025-02-17 Initiation 18 Coated Regular and 18 Coated Super Tampons; Model Number: FG-TMP-MM-IB18180000; Class II 2025-02-17 Initiation 18 Coated Regular and 18 Nude Regular Tampons; Model Number: FG-TMP-MM-IB18001800; Class II 2025-02-17 18 Coated Super Tampons; Model Number: FG-TMP-REF00180000; Class II 2025-02-17 Regular Flow Bundle; Model Number: FG-BNDL-PC-REFRF; Class II 2025-02-17 9 Coated Regular and 9 Nude Regular Tampons; Model Number: FG-TMP-REF09000900; Class II 2025-02-17 Refill 36 Coated Regular Tampons; Model Number: FG-TMP-MM-REF36000000; Class II 2025-02-17 Refill 3 Month Trial Tampon Box; Model Number: FG-TMP-MM-REF09090909; Class II 2025-02-17 All in One Bundle; Model Number: FG-BNDL-PC-REFAIO; Class II 2025-02-17 9 Coated Regular and 9 Coated Super Tampons; Model Number: FG-TMP-REF09090000; Class II 2025-02-17 Initiation 18 Coated Super and 18 Nude Super Tampons; Model Number: FG-TMP-MM-IB00180018; Class II 2025-02-17 9 Coated Regular Tampons and 9 Nude Regular Tampons; Model Number: FG-TMP-RET09000900; Class II 2025-02-17 Refill 18 Coated Regular and 18 Coated Super Tampons; Model Number: FG-TMP-MM-REF18180000; Class II 2025-02-17

RECORDED — these are the FDA's published recall enforcement records (openFDA). Recalls are listed under the exact firm name as filed; a large manufacturer may also file under name variants, so this may not be the company's complete cross-variant record — confirm at the FDA recall database. This page informs and routes; it is not medical advice or a verdict on the company.

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