Z-0397-2026Class II
Refill 3 Month Regular Flow Bundle; Model Number: FG-BNDL-PC-MM-REFRF
Daye (Anne's Day Ltd) / initiated 2025-02-17 / Open, Classified
DAYE (ANNE'S DAY LTD) began a recall of Refill 3 Month Regular Flow Bundle; Model Number: FG-BNDL-PC-MM-REFRF on . FDA classified it as Class II and gives the reason as "Product lacks 510(k) clearance". As of , the recall status on record is Open, Classified.
Recall record
- Recall number
- Z-0397-2026
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- Daye (Anne's Day Ltd)
- Product
- Refill 3 Month Regular Flow Bundle; Model Number: FG-BNDL-PC-MM-REFRF;
- Product code
- HEB Tampon, Menstrual, Unscented
- Reason for recall
- Product lacks 510(k) clearance.
- FDA root cause
- No Marketing Application
- Action
- On February 17, 2025 emails were sent to customers. In light of this pause, we will unfortunately need to cancel your CBD tampon subscription at this time. We understand how disappointing this news may be, and we want you to know how much we appreciate your understanding and loyalty. As a token of our gratitude, we are giving you a $20 credit which will be automatically applied to your next order. You 1II see this reflected in your total when you proceed to checkout. This credit con be used for any product on our website, including our Nude Organic Tampons, which are made with the same commitment to quality and safety you trust from Daye. We know this product has been important to many of you, and we don't want to leave you without support. Our customer core team is here to help you explore alternative options and answer any questions you may have during this transition. You can reach us by email at [email protected].
- Quantity in commerce
- 3074 packs
- Distribution
- US Nationwide distribution.
- Product codes and lots
- Model Number: FG-BNDL-PC-MM-REFRF; UDI-DI: 5060994741612; Lot numbers: 20CR0014, 20CS0034, 20CS0037, 20CS0038, 20CS0039, 20CS0040, 20CS0041, CR001597, CR001598, CR001599, CR001616, CR001616NR001893, CR001617, CR001617CS002165, CR001617NR001844ST23/R/3001-0523ADL, CR001617NR001902, CR001619, CR001623, CR001625, CR001625NR001844ST23/R/3001-0523ADL, CR001626, CR001627, CR001629, CR001633, CR001636, CR001638, CR001640, CR001643, CR001645, CR001655, CR001661, CR001662, CR003000, CR003001, CR003002, CR003005, CR003008, CR003009, CR003020, CR003022, CR003027, CR003031, CR003032, CR003038, CS002088, CS002119, CS002120, CS002121, CS002122, CS002143, CS002144, CS002159, CS002164, CS002164NS001653, CS002165, CS002165NS001653, CS002166, CS002166NS001648ST23/M/3001-0223ADL, CS002167, CS002168, CS002169, CS002177, CS002181, CS002183, CS002195, CS002196, CS003005, CS003015, CS003016, CS003022, CS003034, CS003048, CS003049, CS003050, CS003052, CS003053, CS003054, CS003055, CS003057, CS003062, CS003081, CR001615, CR001616CS002163NR001890NS001649, CR001616CS002163NR001892NS001650, CR001616CS002164, CR001617CS002165, CR001655CS002196, CS002163, CS002164, CR001661NR002015, CS003005NS001775, CR003000, CS003005, CS003016, CS003022, CR003000, CR003000, CR003000NR002173, CS003022NS001781.
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-0379-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0380-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0381-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0382-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0383-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0384-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0385-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0386-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0387-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0388-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0389-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0390-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0391-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0392-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0393-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0394-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0395-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0396-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0397-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0398-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0399-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0400-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0401-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0402-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0403-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0404-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0405-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0406-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0407-2026 | Class II | Ongoing | Voluntary: Firm initiated |
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