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U.S. Department of Health and Human Services

Class 2 Device Recall Daye Coated Tampons

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 Class 2 Device Recall Daye Coated Tamponssee related information
Date Initiated by FirmFebruary 17, 2025
Date PostedOctober 28, 2025
Recall Status1 Open3, Classified
Recall NumberZ-0388-2026
Recall Event ID 97718
Product Classification Tampon, menstrual, unscented - Product Code HEB
ProductRegular Flow Bundle; Model Number: FG-BNDL-PC-REFRF;
Code Information Model Number: FG-BNDL-PC-REFRF; UDI-DI: 5060994741582; 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.
Recalling Firm/
Manufacturer		 DAYE (ANNE'S DAY LTD)
Biscuit Factory Business Complex
100 Drummond Road
London United Kingdom
Manufacturer Reason
for Recall		Product lacks 510(k) clearance.
FDA Determined
Cause 2		No Marketing Application
ActionOn 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.
Quantity in Commerce3074 packs
DistributionUS Nationwide distribution.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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