Anne's Day recalls refill bundles with model FG-BNDL-PC-MM-REFRF due to lacking FDA 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 a specific refill bundle product because it does not have the required FDA 510(k) clearance. This means the product may not be safe for use as intended, though no injuries have been reported.
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 and could pose risks if used without proper approval. However, the recall does not specify any actual injuries or incidents.
Owners of the refill bundle with model number FG-BNDL-PC-MM-REFRF and specific lot numbers listed in the recall are affected. Users of medical devices requiring FDA clearance are at higher risk.
Check for model number FG-BNDL-PC-MM-REFRF on the product. Affected units include specific lot numbers listed in the recall notice, such as 20CR0014, 20CS0034, and others.
Look for the model number FG-BNDL-PC-MM-REFRF and specific lot numbers listed in the recall to determine if your product is affected.
The product lacks FDA 510(k) clearance, which is a regulatory requirement for medical devices in the U.S. This means the device may not meet safety standards.
Check the model number and lot numbers listed in the recall to see if your product is affected. If it is, you should stop using it and contact the manufacturer for further instructions.
The recall states the product lacks 510(k) clearance, but no specific injuries or incidents have been reported. The risk level is unknown as the hazard mechanism is not clearly described.
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-0397-2026 — Anne's Day Anne's Day Hello, I own a Anne's Day that is covered by recall Z-0397-2026 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
