Anne's Day recalls specific refill tampon models due to lack of FDA 510(k) clearance. Affected products may not meet safety standards. Consumers should check model numbers and lot codes listed in the recall notice.
Product lacks 510(k) clearance.
Anne's Day is recalling certain refill tampon models because they lack FDA 510(k) clearance. This means the products may not meet safety standards, though the recall does not indicate immediate harm to users.
The product lacks 510(k) clearance, which is a regulatory requirement for medical devices in the U.S. This means the tampons may not have been tested for safety and effectiveness before being sold. However, the recall does not specify that the tampons are defective or pose an immediate risk of injury.
Women who purchased the specific refill tampon models with the listed model numbers and lot codes are affected. Those using the products for menstrual care are most at risk if the tampons do not meet safety standards.
Check for model number FG-TMP-MM-REF36000000 and lot numbers listed in the recall notice, such as 20CR0014, 20CS0034, or CR001616. The product is sold under the brand Anne's Day.
Verify your tampon's model number and lot code against the list provided in the recall notice.
The product lacks FDA 510(k) clearance, which is a regulatory requirement 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 tampons are affected.
Check the model number (FG-TMP-MM-REF36000000) and lot numbers listed in the recall notice, such as 20CR0014 or CR001616.
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-0390-2026 — Anne's Day Anne's Day Hello, I own a Anne's Day that is covered by recall Z-0390-2026 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.
