Anne's Day recalls All in One Bundle (model FG-BNDL-PC-REFAIO) due to lack of FDA 510(k) clearance. Affected units include specific lot numbers and model variants. Consumers should check their product details and contact the company for guidance.
Product lacks 510(k) clearance.
Anne's Day has recalled all units of their All in One Bundle (model FG-BNDL-PC-REFAIO) because it does not have the required FDA 510(k) clearance. This means the product may not meet safety standards for medical devices, though the recall does not indicate an immediate risk of injury.
The product lacks FDA 510(k) clearance, which is a regulatory requirement for medical devices to ensure they are safe and effective. Without this clearance, the device may not meet the necessary safety standards, but the recall does not specify an immediate hazard like injury or malfunction.
Anyone who purchased the All in One Bundle from Anne's Day between the specified dates. Users with the listed model numbers and lot codes are most at risk due to the lack of regulatory clearance.
Check for the model number FG-BNDL-PC-REFAIO and lot numbers listed in the recall (e.g., 20CR0014, 20CS0034, etc.). The product may also have a UDI-DI code 5060994741575.
Look for the model number FG-BNDL-PC-REFAIO and lot numbers listed in the recall to confirm if your product is affected.
The product lacks FDA 510(k) clearance, which is required for medical devices to ensure safety and effectiveness.
Check for the model number FG-BNDL-PC-REFAIO and lot numbers listed in the recall (e.g., 20CR0014, 20CS0034, etc.).
The recall does not specify a remedy, so contact Anne's Day directly for guidance on next steps.
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-0387-2026 — Anne's Day Anne's Day Hello, I own a Anne's Day that is covered by recall Z-0387-2026 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.
