Anne's Day recalls 9 Coated Regular and 9 Coated Super Tampons with model FG-TMP-REF09090000 due to lacking FDA 510(k) clearance. Consumers should check lot numbers for affected products.
Product lacks 510(k) clearance.
Anne's Day is recalling 9 Coated Regular and 9 Coated Super Tampons that lack FDA 510(k) clearance. This means the products may not be safe for use as they haven't been approved by the U.S. Food and Drug Administration.
The product lacks 510(k) clearance, which is required for medical devices in the U.S. This means the tampons have not been approved by the FDA for safety and effectiveness. Without this clearance, there is a potential risk of harm, though the exact nature of the risk is not specified in the recall notice.
Women who purchased these specific tampon models between 2023 and 2024 are affected. Those with the listed lot numbers or model FG-TMP-REF09090000 are most at risk.
Check for model number FG-TMP-REF09090000 and lot numbers listed in the recall notice, such as 20CR0014, 20CS0034, and others. Products sold between 2023 and 2024 are included in this recall.
Review the model number and lot numbers listed in the recall notice to confirm if your tampons are affected.
The product lacks 510(k) clearance, which is required for medical devices in the U.S. This means the tampons have not been approved by the FDA for safety and effectiveness.
Check for model number FG-TMP-REF09090000 and lot numbers such as 20CR0014, 20CS0034, and others listed in the recall notice.
The recall notice does not specify a remedy, so you should check the product details to confirm if they are affected and contact the manufacturer for further guidance.
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-0383-2026 — Anne's Day Anne's Day Hello, I own a Anne's Day that is covered by recall Z-0383-2026 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.
