Anne's Day is recalling Initiation 18 Coated and Nude Regular tampons due to lack of FDA 510(k) clearance. Affected products have specific model numbers and lot codes. Consumers should check their items and contact the company for details.
Product lacks 510(k) clearance.
Anne's Day is recalling certain Initiation 18 Coated and Nude Regular tampons because they lack FDA 510(k) clearance. This means the product may not meet safety standards for medical devices, though the recall does not indicate immediate injury risk.
The product lacks FDA 510(k) clearance, which is required for medical devices to ensure they meet safety and performance standards. This means the tampons may not be safe for use as medical products, though the recall does not specify immediate injury risks.
Women who purchased the specific model numbers and lot codes listed in the recall notice are affected. Those using the tampons for medical purposes may be at slightly higher risk due to the lack of regulatory clearance.
Check for model number FG-TMP-MM-IB18001800 on the tampon packaging. Affected lots include codes like 20CR0014, 20CS0034, and CR001597 through CR003038.
Look for model number FG-TMP-MM-IB18001800 on the tampon packaging.
Reach out to Anne's Day customer service for further assistance with the recall.
The product lacks FDA 510(k) clearance, which is required for medical devices to ensure safety and performance standards.
The recall does not indicate immediate injury risk, so you do not need to stop using them immediately. However, you should check if your product is affected and contact Anne's Day for guidance.
Check for model number FG-TMP-MM-IB18001800 and lot codes listed in the recall notice, such as 20CR0014 or CR001597.
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-0402-2026 — Anne's Day Anne's Day Hello, I own a Anne's Day that is covered by recall Z-0402-2026 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.
