Anne's Day recalls Regular Flow Bundle (model FG-BNDL-PC-REFRF) due to lacking FDA 510(k) clearance. Affected units include specific lot numbers. Consumers should contact the company for details.
Product lacks 510(k) clearance.
Anne's Day is recalling its Regular Flow Bundle product because it does not have the required FDA 510(k) clearance. This means the device may not be safe for use as intended, though the recall does not specify immediate risks to consumers.
The product lacks FDA 510(k) clearance, which is a regulatory requirement for medical devices to ensure safety and effectiveness. Without this clearance, the device may not meet the necessary standards for use, potentially leading to health risks if used improperly.
Owners of the Regular Flow Bundle with model number FG-BNDL-PC-REFRF and specific lot numbers listed in the recall are affected. Individuals using medical devices that require FDA clearance may be at risk if they have this product.
Check for the model number FG-BNDL-PC-REFRF on the product. Affected units include specific lot numbers listed in the recall, such as 20CR0014, 20CS0034, and others.
Look for the model number FG-BNDL-PC-REFRF on the device to confirm if it is affected.
Reach out to Anne's Day directly for specific instructions on what to do with the affected product.
The product lacks FDA 510(k) clearance, which is required for medical devices to ensure safety and effectiveness.
Check the model number and lot numbers listed in the recall. Contact Anne's Day for specific instructions.
The recall states the product lacks FDA clearance, but the official notice does not specify any immediate injury risks.
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-0388-2026 — Anne's Day Anne's Day Hello, I own a Anne's Day that is covered by recall Z-0388-2026 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.
