Anne's Day recalls Initiation 3 Month Regular Flow Bundle (model FG-BNDL-PC-MM-IBRF) due to lack of 510(k) clearance. Affected units sold with specific lot numbers. Consumers should check their product details.
Product lacks 510(k) clearance.
Anne's Day is recalling its Initiation 3 Month Regular Flow Bundle because it lacks required 510(k) clearance. This means the product may not meet safety standards for medical devices, though no specific 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 have been properly tested for safety before being sold, potentially leading to health risks if used incorrectly.
Users of the Initiation 3 Month Regular Flow Bundle with model number FG-BNDL-PC-MM-IBRF are affected. Individuals who purchased this product from retailers or online are most at risk.
Check for model number FG-BNDL-PC-MM-IBRF on the product. Affected units include specific lot numbers listed in the recall notice, such as 20CR0014, 20CS0034, and others.
Identify the model number and lot numbers to confirm if your product is affected.
The product lacks 510(k) clearance, a regulatory requirement for medical devices in the U.S. This means it may not meet safety standards.
Check the model number and lot numbers listed in the recall notice to see if your product is affected. No specific remedy is provided in this recall.
The recall states the product lacks 510(k) clearance, but no specific injuries have been reported. The risk 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-0406-2026 — Anne's Day Anne's Day Hello, I own a Anne's Day that is covered by recall Z-0406-2026 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.
