Three month trial tampon boxes recalled for lacking 510k clearance
Daye is recalling 3,074 packs of the Initiation 3 Month Trial Tampon Box because the product lacks 510(k) clearance.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: Scored 2 because the record cites the absence of 510(k) clearance rather than any identified defect or reported harm.
Plain-English summary
The Initiation 3 Month Trial Tampon Box, model FG-TMP-MM-IB09090909, from Daye (Anne's Day Ltd), is being recalled because the product lacks 510(k) clearance.
The recall covers 3,074 packs carrying UDI-DI 5060994741636, across lots 20CR0014, 20CS0034, 20CS0037 and 20CS0038. The product was distributed nationwide in the United States. The FDA has classified the action as Class II.
The enforcement record describes a missing premarket clearance rather than an identified defect, and reports no injuries.
Anyone holding the product should follow the firm's instructions.
The recalled product
- Product
- Initiation 3 Month Trial Tampon Box; Model Number: FG-TMP-MM-IB09090909;
- Manufacturer
- DAYE (ANNE'S DAY LTD)
- Affected units
- 3,074
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Model Number: FG-TMP-MM-IB09090909
- UDI-DI: 5060994741636
- Lot numbers: 20CR0014
- 20CS0034
- 20CS0037
- 20CS0038
- 20CS0039
- 20CS0040
- 20CS0041
- CR001597
- CR001598
- CR001599
- CR001616
- CR001616NR001893
- CR001617
- CR001617CS002165
- CR001617NR001844ST23/R/3001-0523ADL
- CR001617NR001902
- CR001619
- CR001623
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 29 recalled by DAYE (ANNE'S DAY LTD) under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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