Anne's Day is recalling Initiation 36 Coated Regular Tampons with model FG-TMP-MM-IB36000000 due to lack of FDA 510(k) clearance. Consumers should check lot numbers for affected items.
Product lacks 510(k) clearance.
Anne's Day is recalling specific models of Initiation 36 Coated Regular Tampons because they lack FDA 510(k) clearance. This means the product may not be safe for use as intended without proper regulatory approval.
The product lacks 510(k) clearance, which is required by the FDA to ensure medical devices meet safety standards. Without this clearance, the tampons may not be safe for use and could pose health risks.
Women who purchased the specific model numbers listed in the recall notice are affected. Those using tampons without proper FDA clearance may face safety risks.
Check the model number FG-TMP-MM-IB36000000 on the tampon packaging. Affected items have specific lot numbers listed in the recall notice, including many CR0016xx and CS0021xx codes.
Look for the model number FG-TMP-MM-IB36000000 on the tampon packaging.
Reach out to Anne's Day directly for more information about the recall and affected items.
The product lacks FDA 510(k) clearance, which is required for medical devices to ensure safety standards are met.
Check the model number FG-TMP-MM-IB36000000 and look for specific lot numbers listed in the recall notice, such as CR0016xx or CS0021xx codes.
Contact Anne's Day directly for more information about the recall and affected items.
We’ve drafted a message you can send Anne's Day to request your refund or repair — edit it as you like.
Subject: Recall Z-0399-2026 — Anne's Day Anne's Day Hello, I own a Anne's Day that is covered by recall Z-0399-2026 from Anne's Day. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.