Device recall
REF:HF2PC9 HomeFill Oxygen System, HomeFill Cylinder M9 with Integrated Conserver
- Recall number
- Z-3222-2026
- Event id
- 99660
- Status
- Ongoing
- FDA classification
- Class II
- Recalling firm
- Ventec Life Systems, Inc.
- Report date
- Sep 30, 2026
- Posted
- Sep 18, 2026
- Initiated
- Jul 28, 2026
- Center classification date
- Sep 18, 2026
- Product code
- ECX
- Device type
- Cylinder, Compressed Gas, And Valve
- Reason
- Labeling; Oxygen Cylinders do not contain required medical gas labeling
- Root cause
- Process control
- Quantity
- 2 units
- Code info
- UDI:00850018761352/Serial #s: 24IKMA0029J and 24IKMA002CM
- Distribution
- US Nationwide distribution in the states of FL, IA, OH, NE, TN.
- Voluntary or mandated
- Voluntary: Firm initiated
- Location
- Bothell, WA, United States