Anne's Day recalls Initiation 36 Coated Super Tampons with model FG-TMP-MM-IB00360000 due to lacking 510(k) clearance. Affected units include specific lot numbers. Consumers should check their product details.
Product lacks 510(k) clearance.
Anne's Day is recalling Initiation 36 Coated Super Tampons with model number FG-TMP-MM-IB00360000 because they lack 510(k) clearance. This means the product may not meet safety standards for medical devices, though the recall does not specify immediate risks to users.
The product lacks 510(k) clearance, which is required for medical devices in the U.S. to ensure they meet safety and effectiveness standards. Without this clearance, the tampons may not function as intended or could pose risks to users.
Anyone who purchased the Initiation 36 Coated Super Tampons with model number FG-TMP-MM-IB00360000 or the listed lot numbers. Users of medical-grade tampons are most at risk due to potential safety issues.
Check for the model number FG-TMP-MM-IB00360000 on the product packaging. The affected lot numbers include specific codes like 20CR0014, 20CS0034, and others listed in the recall notice.
Look for the model number FG-TMP-MM-IB00360000 and the listed lot numbers on the product packaging.
The product lacks 510(k) clearance, which is required for medical devices to ensure safety and effectiveness standards are met.
The recall does not specify a remedy, so check the product details to see if it matches the model and lot numbers listed in the recall notice.
The recall states the product lacks 510(k) clearance, but it does not describe specific safety risks or injuries. The official notice does not provide details on potential harm.
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-0400-2026 — Anne's Day Anne's Day Hello, I own a Anne's Day that is covered by recall Z-0400-2026 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.
