Anne's Day recalls specific refill bundles due to lack of 510(k) clearance. Affected units include model FG-BNDL-PC-MM-REFHF 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 certain refill bundles because they lack required 510(k) clearance. This means the product may not meet safety standards for medical devices, though no injuries have been reported. Consumers should check their product details to see if they are affected.
The product lacks 510(k) clearance, which is a regulatory approval required for medical devices in the U.S. This means the product may not meet safety standards, but the specific risks are not detailed in the recall notice.
Users of the refill bundles with model number FG-BNDL-PC-MM-REFHF and listed lot numbers are affected. Those who have purchased the product from the manufacturer or retailers selling it are most at risk.
Check for model number FG-BNDL-PC-MM-REFHF on the product. Look for lot numbers listed in the recall, such as 20CR0014, 20CS0034, and others provided in the notice.
Review the model number and lot numbers on your product to determine if it is affected by this recall.
The product lacks 510(k) clearance, which is a regulatory approval required for medical devices in the U.S. This means the product may not meet safety standards.
Check for model number FG-BNDL-PC-MM-REFHF and look for lot numbers listed in the recall, such as 20CR0014, 20CS0034, and others provided in the notice.
The recall notice does not specify a remedy, so contact Anne's Day directly for 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-0398-2026 — Anne's Day Anne's Day Hello, I own a Anne's Day that is covered by recall Z-0398-2026 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.
