Anne's Day recalls specific models of Refill 36 Coated Super Tampons due to lack of FDA 510(k) clearance. Affected products include model FG-TMP-MM-REF00360000 with listed lot numbers. Consumers should check their product details and contact the company for guidance.
Product lacks 510(k) clearance.
Anne's Day is recalling specific models of Refill 36 Coated Super Tampons because they lack FDA 510(k) clearance. This means the product may not be safe for use as intended, though the recall does not specify immediate health risks.
The product lacks 510(k) clearance, which is a regulatory requirement for medical devices in the U.S. This means the product has not been approved by the FDA for safety and effectiveness before being sold. Without this clearance, the product may not meet safety standards, but the recall does not specify how this affects user safety in practice.
Users of the recalled Refill 36 Coated Super Tampons with model number FG-TMP-MM-REF00360000 and listed lot numbers are affected. Individuals who purchased these products from retailers or online should check their specific model and lot numbers.
Check for model number FG-TMP-MM-REF00360000 on the product packaging. Look for lot numbers listed in the recall, such as 20CR0014, 20CS0034, and others. The product may also have a UDI-DI code 5060994741186.
Identify your product's model number and lot numbers to confirm if it is affected by this recall.
The product lacks FDA 510(k) clearance, which is required for medical devices in the U.S. This means it has not been approved for safety and effectiveness before being sold.
Check for model number FG-TMP-MM-REF00360000 and lot numbers listed in the recall, such as 20CR0014, 20CS0034, and others.
The recall does not specify a remedy, so contact Anne's Day directly for guidance on next steps.
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-0391-2026 — Anne's Day Anne's Day Hello, I own a Anne's Day that is covered by recall Z-0391-2026 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.
