Initiation 3 Month Regular Flow Bundle recall
Initiation 3 Month Regular Flow Bundle; Model Number: FG-BNDL-PC-MM-IBRF;
Why was Initiation 3 Month Regular Flow Bundle recalled?
Product lacks 510(k) clearance.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Model Number: FG-BNDL-PC-MM-IBRF; UDI-DI: 5060994741650; 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,
- Product
- Initiation 3 Month Regular Flow Bundle; Model Number: FG-BNDL-PC-MM-IBRF;
- Recalling firm
- DAYE (ANNE'S DAY LTD)
- Quantity
- 3074 packs
- Distribution
- US Nationwide distribution.
- Recall date
- November 5, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)