FDA Device recall Z-0387-2026
All in One Bundle
- FDA Device
- Class II
- ongoing
- Published 2025-11-05
On 2025-11-05 the FDA classified a Class II recall of All in One Bundle by Daye Anne S Day, citing product lacks 510(k) clearance.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0387-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-02-17 |
| Published | 2025-11-05 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Daye Anne S Day |
| Distribution | US |
Product
All in One Bundle; Model Number: FG-BNDL-PC-REFAIO;
Reason
Product lacks 510(k) clearance.
Identifiers
| code_info | Model Number: FG-BNDL-PC-REFAIO; UDI-DI: 5060994741575; Lot numbers: 20CR0014, 20CS0034, 20CS0037, 20CS0038, 20CS0039,…Model Number: FG-BNDL-PC-REFAIO; UDI-DI: 5060994741575; 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, |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0387-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.