Official recall notice
FDA DeviceClass IINotable
FDA Recall: REF: HF2POSTD HomeFill Oxygen System HomeFill cylinder D with CGA870 Compatible Post Valve
- Recall date
- 2026-09-30
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
Hazard
Labeling; Oxygen Cylinders do not contain required medical gas labeling
Product description
Labeling; Oxygen Cylinders do not contain required medical gas labeling
Affected products
UDI:00850018761376/ Serial #s: 25EKMA00BAC 25EKMA009L3 25EKMA009CM 25EKMA009J8 25GKMA00077 25GKMA0007B 25GKMA0009Z 25GKMA0004U 25GKMA000CS 25GKMA000CR 25GKMA000CX 25GKMA000D0 25GKMA000LL 25GKMA000N1 25GKMA000UD 25GKMA000D1 25GKMA000TN 25GKMA000D2 25GKMA000UC 25GKMA000LK 25GKMA000UA 25GKMA000UB 25GKMA000UE 25GKMA000CY 25GKMA000UF