Daye (Anne's Day Ltd) has voluntarily recalled approximately 3,074 packs of various tampon products and bundles because they were sold without the required FDA 510(k) clearance. The recall includes Coated and Nude tampons in both Regular and Super sizes, along with various trial boxes, refill bundles, and initiation sets. These medical devices have not been reviewed by the FDA for safety or effectiveness, though no incidents or injuries have been reported to date.
Products sold without FDA clearance have not been evaluated for safety, quality, or performance standards. This lack of regulatory review means there is no verification that the materials and manufacturing processes are safe for consumer use.
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Quantity: 3074 packs
Quantity: 3074 packs
Quantity: 3074 packs
Quantity: 3074 packs
Quantity: 3074 packs
Quantity: 3074 packs
Quantity: 3074 packs
Quantity: 3074 packs
Quantity: 3074 packs
Quantity: 3074 packs
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES ยท Raw API Response
openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.