Coated regular tampon packs recalled because the product lacks 510k clearance
Daye is recalling 3,074 packs of 18 Coated Regular Tampons 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
18 Coated Regular Tampons, model FG-TMP-REF18000000, from Daye (Anne's Day Ltd), are being recalled because the product lacks 510(k) clearance.
The recall covers 3,074 packs carrying UDI-DI 05060994741148, across lots including 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
- 18 Coated Regular Tampons; Model Number: FG-TMP-REF18000000;
- Manufacturer
- DAYE (ANNE'S DAY LTD)
- Hazard
- missing-clearance
- regulatory-noncompliance
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-REF18000000
- UDI-DI: 05060994741148
- 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.
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