Anne's Day recalls specific models of Initiation 18 Coated Super and Nude Super tampons due to lack of 510(k) clearance. Consumers should check product details and contact the company for guidance.
Product lacks 510(k) clearance.
Anne's Day is recalling certain models of Initiation 18 Coated Super and Nude Super tampons because they do not have the required 510(k) clearance. This means the products may not meet safety standards for medical devices, though the recall does not indicate immediate risk of injury.
The product lacks 510(k) clearance, which is a regulatory approval required for medical devices in the U.S. This means the tampons may not meet safety standards, but the recall does not specify a risk of injury or harm during normal use.
Women who purchased the specific model numbers listed in the recall notice are affected. Those using these tampons should check if their product matches the described model numbers.
Check for model number FG-TMP-MM-IB00180018 on the tampon packaging. The recall includes specific lot numbers and UDI-DI codes listed in the notice. If your tampon matches these details, it is part of the recall.
Look for the model number FG-TMP-MM-IB00180018 on the tampon packaging or check the lot numbers listed in the recall notice.
The product lacks 510(k) clearance, which is a regulatory approval required for medical devices in the U.S. This means the tampons may not meet safety standards.
The recall does not indicate an immediate risk of injury, so you do not need to stop using them. However, you should check if your product matches the recalled model numbers.
Check the model number FG-TMP-MM-IB00180018 on the packaging and verify against the list of lot numbers provided in the recall notice.
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-0403-2026 — Anne's Day Anne's Day Hello, I own a Anne's Day that is covered by recall Z-0403-2026 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.
