Anne's Day is recalling Initiation 18 Coated Regular and Super Tampons with model FG-TMP-MM-IB18180000 due to lack of 510(k) clearance. Consumers should check lot numbers listed in the recall notice.
Product lacks 510(k) clearance.
Anne's Day is recalling specific models of Initiation 18 Coated Regular and Super Tampons because they lack 510(k) clearance. This means the product may not meet safety standards for medical devices, though no injuries have been reported.
The product lacks 510(k) clearance, which is required for medical devices in the U.S. to ensure they meet safety and performance standards. Without this clearance, the product may not function as intended or could pose risks during use.
Women who purchased the specific model numbers listed in the recall notice are affected. Those using the product for medical purposes may be at higher risk due to the lack of regulatory clearance.
Check the product label for model number FG-TMP-MM-IB18180000. The recall includes specific lot numbers listed in the notice, such as 20CR0014, 20CS0034, and others.
Look for the model number FG-TMP-MM-IB18180000 on the tampon packaging or label.
The product lacks 510(k) clearance, which is required for medical devices in the U.S. to ensure they meet safety and performance standards.
Check the product label for model number FG-TMP-MM-IB18180000 and verify the lot numbers listed in the recall notice, such as 20CR0014 or 20CS0034.
The recall notice does not specify a remedy, so no action is required beyond checking if the product is affected.
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-0401-2026 — Anne's Day Anne's Day Hello, I own a Anne's Day that is covered by recall Z-0401-2026 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.
