Daye Tampon Refill Mix (Daye) – 510(k) Clearance Missing (2025)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Refill 18 Coated Regular and 18 Coated Super Tampons; Model Number: FG-TMP-MM-REF18180000;
Brand
DAYE (ANNE'S DAY LTD) Biscuit Factory Business Complex 100 Drummond Road London United Kingdom
Lot Codes / Batch Numbers
Model Number: FG-TMP-MM-REF18180000, UDI-DI: 5060994741216, 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.
Products Sold
Model Number: FG-TMP-MM-REF18180000; UDI-DI: 5060994741216; 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.
DAYE (ANNE'S DAY LTD) Biscuit Factory Business Complex 100 Drummond Road London United Kingdom is recalling Refill 18 Coated Regular and 18 Coated Super Tampons; Model Number: FG-TMP-MM-REF18180000; due to Product lacks 510(k) clearance.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Product lacks 510(k) clearance.
Recommended Action
Per FDA guidance
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 hello@yourdaye.com.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026