CLASS II ONGOING Device recall · Reported 5 Nov 2025 · FDA Enforcement Report
Initiation 18 Coated Regular and 18 Nude Regular Tampons recalled
Daye (anne's Day Ltd) is recalling Initiation 18 Coated Regular and 18 Nude Regular Tampons, distributed nationwide in the US. The recall was initiated on 17 Feb 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0402-2026
- FDA event ID
- 97718
- Recalling firm
- Daye (anne's Day Ltd), London, N/A
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 17 Feb 2025
- FDA classified
- 28 Oct 2025
- Reported
- 5 Nov 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 17 Feb 2025 | Recall initiated by company | |
| 28 Oct 2025 | Classified by FDA | +253 days |
| 5 Nov 2025 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Product lacks 510(k) clearance.
Product as listed by the FDA
Initiation 18 Coated Regular and 18 Nude Regular Tampons; Model Number: FG-TMP-MM-IB18001800;
Where it was distributed
US Nationwide distribution.
Questions about this recall
Is Initiation 18 Coated Regular and 18 Nude Regular Tampons recalled?
Yes. Daye (anne's Day Ltd) recalled Initiation 18 Coated Regular and 18 Nude Regular Tampons on 17 Feb 2025. The recall is Class II and its status is Ongoing. Recall number Z-0402-2026.
Why was it recalled?
Product lacks 510(k) clearance.
Which lots are affected?
Model Number: FG-TMP-MM-IB18001800; UDI-DI: 5060994741254; 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,
Where was it sold?
US Nationwide distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Daye (anne's Day Ltd)
All 29| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Refill 18 Coated Regular and 18 Coated Super Tampons recalled | Daye (anne's Day Ltd) | Other | Nationwide |
| Device | CLASS II | 9 Coated Regular Tampons and 9 Nude Regular Tampons recalled | Daye (anne's Day Ltd) | Other | Nationwide |
| Device | CLASS II | Initiation 18 Coated Super and 18 Nude Super Tampons recalled | Daye (anne's Day Ltd) | Other | Nationwide |
| Device | CLASS II | 9 Coated Regular and 9 Coated Super Tampons recalled | Daye (anne's Day Ltd) | Other | Nationwide |
| Device | CLASS II | All in One Bundle recalled by Daye (anne's Day Ltd) | Daye (anne's Day Ltd) | Other | Nationwide |
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