Anne's Day recalls Initiation 3 Month All in One Bundle (model FG-BNDL-PC-MM-IBAIO) due to lack of 510(k) clearance. Affected units include specific lot numbers and serial codes. Consumers should check their product details.
Product lacks 510(k) clearance.
Anne's Day is recalling its Initiation 3 Month All in One Bundle because it lacks required 510(k) clearance. This means the product may not meet safety standards for medical devices, though the recall does not specify immediate risks or injuries.
The product lacks 510(k) clearance, which is a regulatory requirement for medical devices in the U.S. This means the device may not meet safety standards, but the recall does not specify how this could cause harm or injury in normal use.
Anyone who purchased the Initiation 3 Month All in One Bundle with model number FG-BNDL-PC-MM-IBAIO from the listed lot numbers or serial codes. Users with the product are most at risk if they have medical device needs.
Check for model number FG-BNDL-PC-MM-IBAIO on the product. Affected units include specific lot numbers and serial codes listed in the recall notice.
Look for the model number FG-BNDL-PC-MM-IBAIO and the listed lot numbers or serial codes to confirm if your product is affected.
The recall states the product lacks 510(k) clearance, but it does not specify any immediate safety risks or injuries. The official notice does not describe how this could cause harm.
The recall does not provide a remedy or specific action steps. You should check the product details to see if it matches the affected model and lot numbers listed.
Check for model number FG-BNDL-PC-MM-IBAIO and compare your lot numbers or serial codes with the list provided in the recall notice.
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-0405-2026 — Anne's Day Anne's Day Hello, I own a Anne's Day that is covered by recall Z-0405-2026 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.
