--- title: "Refill 3 Month All in One Bundle; Model Number: FG-BNDL-PC-MM-REFAIO; — FDA record Z-0396-2026 | Is It on Recall" description: "Product lacks 510(k) clearance." url: https://isitonrecall.com/recall/fda-device-z-0396-2026-refill-3-month-all-in-one-bundle-model-number-fg-bndl-pc-mm-refaio/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement # Refill 3 Month All in One Bundle; Model Number: FG-BNDL-PC-MM-REFAIO; — FDA record Z-0396-2026 Reported ongoing Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice. Source date Feb 17, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## What the record says - **Product**: Refill 3 Month All in One Bundle; Model Number: FG-BNDL-PC-MM-REFAIO; - **Reason**: Product lacks 510(k) clearance. - **Classification**: Class II - **Recalling firm**: DAYE (ANNE'S DAY LTD) - **Quantity**: 3074 packs - **Agency-reported status**: Ongoing - **Source record identifier**: Z-0396-2026 [Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0396-2026%22) [What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice. ## Lot and product identifiers | Label field | Details supplied by the agency | | --- | --- | | Lot, code or applicability | Model Number: FG-BNDL-PC-MM-REFAIO; UDI-DI: 5060994741605; Lot numbers: 20CR0014, 20CS0034, 20CS0037, 20CS0038, 20CS0039, 20CS0040, 20CS0041, CR001597, CR001598, CR001599, CR001616, CR001616NR001893, CR001617, CR001617CS002165, CR001617NR001844ST23/R/3001-0523ADL, CR001617NR001902, CR001619, CR001623, CR001625, CR001625NR001844ST23/R/3001-0523ADL, CR001626, CR001627, CR001629, CR001633, CR001636, CR001638, CR001640, CR001643, CR001645, CR001655, CR001661, CR001662, CR003000, CR003001, CR003002, CR003005, CR003008, CR003009, CR003020, CR003022, CR003027, CR003031, CR003032, CR003038, CS002088, CS002119, CS002120, CS002121, CS002122, CS002143, CS002144, CS002159, CS002164, CS002164NS001653, CS002165, CS002165NS001653, CS002166, CS002166NS001648ST23/M/3001-0223ADL, CS002167, CS002168, CS002169, CS002177, CS002181, CS002183, CS002195, CS002196, CS003005, CS003015, CS003016, CS003022, CS003034, CS003048, CS003049, CS003050, CS003052, CS003053, CS003054, CS003055, CS003057, CS003062, CS003081, CR001615, CR001616CS002163NR001890NS001649, CR001616CS002163NR001892NS001650, CR001616CS002164, CR001617CS002165, CR001655CS002196, CS002163, CS002164, CR001661NR002015, CS003005NS001775, CR003000, CS003005, CS003016, CS003022, CR003000, CR003000, CR003000NR002173, CS003022NS001781, | Match all identifying details in the current notice. A brand name alone is not enough. ## Distribution US Nationwide distribution. States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address. - [Alaska](https://isitonrecall.com/state/alaska/) - [Alabama](https://isitonrecall.com/state/alabama/) - [Arkansas](https://isitonrecall.com/state/arkansas/) - [Arizona](https://isitonrecall.com/state/arizona/) - [California](https://isitonrecall.com/state/california/) - [Colorado](https://isitonrecall.com/state/colorado/) - [Connecticut](https://isitonrecall.com/state/connecticut/) - [Delaware](https://isitonrecall.com/state/delaware/) - [Florida](https://isitonrecall.com/state/florida/) - [Georgia](https://isitonrecall.com/state/georgia/) - [Hawaii](https://isitonrecall.com/state/hawaii/) - [Iowa](https://isitonrecall.com/state/iowa/) - [Idaho](https://isitonrecall.com/state/idaho/) - [Illinois](https://isitonrecall.com/state/illinois/) - [Indiana](https://isitonrecall.com/state/indiana/) - [Kansas](https://isitonrecall.com/state/kansas/) - [Kentucky](https://isitonrecall.com/state/kentucky/) - [Louisiana](https://isitonrecall.com/state/louisiana/) - [Massachusetts](https://isitonrecall.com/state/massachusetts/) - [Maryland](https://isitonrecall.com/state/maryland/) - [Maine](https://isitonrecall.com/state/maine/) - [Michigan](https://isitonrecall.com/state/michigan/) - [Minnesota](https://isitonrecall.com/state/minnesota/) - [Missouri](https://isitonrecall.com/state/missouri/) - [Mississippi](https://isitonrecall.com/state/mississippi/) - [Montana](https://isitonrecall.com/state/montana/) - [North Carolina](https://isitonrecall.com/state/north-carolina/) - [North Dakota](https://isitonrecall.com/state/north-dakota/) - [Nebraska](https://isitonrecall.com/state/nebraska/) - [New Hampshire](https://isitonrecall.com/state/new-hampshire/) - [New Jersey](https://isitonrecall.com/state/new-jersey/) - [New Mexico](https://isitonrecall.com/state/new-mexico/) - [Nevada](https://isitonrecall.com/state/nevada/) - [New York](https://isitonrecall.com/state/new-york/) - [Ohio](https://isitonrecall.com/state/ohio/) - [Oklahoma](https://isitonrecall.com/state/oklahoma/) - [Oregon](https://isitonrecall.com/state/oregon/) - [Pennsylvania](https://isitonrecall.com/state/pennsylvania/) - [Rhode Island](https://isitonrecall.com/state/rhode-island/) - [South Carolina](https://isitonrecall.com/state/south-carolina/) - [South Dakota](https://isitonrecall.com/state/south-dakota/) - [Tennessee](https://isitonrecall.com/state/tennessee/) - [Texas](https://isitonrecall.com/state/texas/) - [Utah](https://isitonrecall.com/state/utah/) - [Virginia](https://isitonrecall.com/state/virginia/) - [Vermont](https://isitonrecall.com/state/vermont/) - [Washington](https://isitonrecall.com/state/washington/) - [Wisconsin](https://isitonrecall.com/state/wisconsin/) - [West Virginia](https://isitonrecall.com/state/west-virginia/) - [Wyoming](https://isitonrecall.com/state/wyoming/) ## Dates in the source - **Report date**: Nov 5, 2025 - **Recall initiation date**: Feb 17, 2025 - **Center classification date**: Oct 28, 2025 FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable. ## What to do next Read the official notice for the action that applies to your exact product. [Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0396-2026%22) ## Related records [Medical devices records](https://isitonrecall.com/category/medical-devices/) [DAYE (ANNE'S DAY LTD) records](https://isitonrecall.com/brand/daye-anne-s-day-ltd/)