Initiation three month heavy flow bundles recalled for lacking 510k clearance
Daye is recalling 3,074 packs of its Initiation 3 Month Heavy Flow Bundle 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 Heavy Flow Bundle, model FG-BNDL-PC-MM-IBHF, 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 5060994741667, 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
- Initiation 3 Month Heavy Flow Bundle; Model Number: FG-BNDL-PC-MM-IBHF;
- 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-BNDL-PC-MM-IBHF
- UDI-DI: 5060994741667
- 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.
See all 29 products in this recall →Related recalls
Same manufacturer · DAYE (ANNE'S DAY LTD)
See all →- ModerateHeavy Flow Bundles recalled because the product lacks 510k clearance
FDA (Devices) · 2025-11-05
- ModerateInitiation coated and nude super tampons recalled for lacking 510k clearance
FDA (Devices) · 2025-11-05
- ModerateCoated and nude regular tampon packs recalled for lacking 510k clearance
FDA (Devices) · 2025-11-05
- ModerateRegular Flow Bundles recalled because the product lacks 510k clearance
FDA (Devices) · 2025-11-05
- ModerateCoated and nude regular tampons recalled because product lacks 510k clearance
FDA (Devices) · 2025-11-05
Same hazard · missing clearance
See all →- ModerateWondfo Streptococcal A self-test recalled because it lacks FDA clearance
FDA (Devices) · 2026-03-18
- ModerateClearest Strep-A cassette test recalled because it lacks FDA clearance
FDA (Devices) · 2026-03-18
- ModerateBisaf Strep A self-test recalled because it lacks FDA clearance
FDA (Devices) · 2026-03-18
- ModerateMeasles antibody tests recalled for being distributed without premarket clearance
FDA (Devices) · 2025-11-26
- ModeratePlatelet reactivity tests recalled after an uncleared device was distributed
FDA (Devices) · 2025-11-19