Anne's Day recalls 3-month refill bundles with missing 510(k) clearance. Affected units have specific model numbers and lot codes. Consumers should check their product details to determine if they are impacted.
Product lacks 510(k) clearance.
Anne's Day is recalling its Refill 3 Month All in One Bundle due to a lack of 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 model numbers to see if they are affected.
The product lacks 510(k) clearance, which is required by the FDA for medical devices to ensure safety and effectiveness. Without this clearance, the device may not meet necessary safety standards, potentially leading to health risks if used improperly.
Owners of the Refill 3 Month All in One Bundle with model number FG-BNDL-PC-MM-REFAIO are affected. Most at risk are individuals using this product for medical purposes.
Check for model number FG-BNDL-PC-MM-REFAIO on the product. Lot numbers include codes like 20CR0014, 20CS0034, and others listed in the recall notice. The product was sold with specific UDI-DI: 5060994741605.
Look for model number FG-BNDL-PC-MM-REFAIO on the product label.
The product lacks 510(k) clearance, which is required by the FDA for medical devices to ensure safety and effectiveness.
Check if your product has model number FG-BNDL-PC-MM-REFAIO and lot numbers listed in the recall notice. If affected, contact the manufacturer for further instructions.
The recall states the product lacks 510(k) clearance, but no specific injuries have been reported. The risk is unknown without additional safety data.
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-0396-2026 — Anne's Day Anne's Day Hello, I own a Anne's Day that is covered by recall Z-0396-2026 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.
