Anne's Day Heavy Flow Bundle (model FG-BNDL-PC-REFHF) recalled due to lack of FDA 510(k) clearance. Affected units include specific lot numbers. Consumers should contact the manufacturer for details.
Product lacks 510(k) clearance.
Anne's Day is recalling its Heavy 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 or injuries.
The product lacks FDA 510(k) clearance, which is a regulatory requirement for medical devices in the United States. This means the device has not been proven safe and effective for its intended use by the Food and Drug Administration. Without this clearance, the device could pose unverified risks to users.
Owners of the Heavy Flow Bundle with model number FG-BNDL-PC-REFHF and specific lot numbers listed in the recall are affected. Individuals using this product for medical purposes may be at higher risk due to the lack of regulatory clearance.
Check for the model number FG-BNDL-PC-REFHF on the product. Affected units include specific lot numbers listed in the recall notice, such as 20CR0014, 20CS0034, and others.
Identify the model number on the device to confirm if it matches FG-BNDL-PC-REFHF.
Reach out to Anne's Day (Anne's Day Ltd) for specific instructions on how to handle the recalled product.
The product lacks FDA 510(k) clearance, which is required for medical devices in the United States. This means it has not been proven safe and effective for its intended use.
Check the model number and lot numbers listed in the recall notice. Contact Anne's Day (Anne's Day Ltd) for specific instructions on how to handle the recalled product.
The recall states the product lacks FDA 510(k) clearance, but it does not specify any immediate risks or injuries. The hazard level is unknown based on the information provided.
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-0389-2026 — Anne's Day Anne's Day Hello, I own a Anne's Day that is covered by recall Z-0389-2026 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.
