FDA Device recall Z-3222-2026
REF:HF2PC9 HomeFill Oxygen System, HomeFill Cylinder M9 with Integrated Conserver
- FDA Device
- Class II
- ongoing
- Published 2026-09-30
On 2026-09-30 the FDA classified a Class II recall of REF:HF2PC9 HomeFill Oxygen System, HomeFill Cylinder M9 with Integrated Conserver by Ventec Life Systems, citing labeling; Oxygen Cylinders do not contain required medical gas labeling.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3222-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-07-28 |
| Published | 2026-09-30 |
| Last updated | 2026-10-06 05:30 UTC |
| Company | Ventec Life Systems |
| Distribution | US |
Product
REF:HF2PC9 HomeFill Oxygen System, HomeFill Cylinder M9 with Integrated Conserver
Reason
Labeling; Oxygen Cylinders do not contain required medical gas labeling
Identifiers
| code_info | UDI:00850018761352/Serial #s: 24IKMA0029J and 24IKMA002CM |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-10-06 05:30 UTC. Current status: ongoing.
Other recalls by Ventec Life Systems
- REF: HF2POSTD HomeFill Oxygen System HomeFill cylinder D with CGA870 Compatible Post Valve
FDA Device · Class II · 2026-09-30 · Ventec Life Systems - HF2P0ST9 HomeFill Oxygen System HomeFill Cylinder M9 with CGA870 Compatible Post Valve
FDA Device · Class II · 2026-09-30 · Ventec Life Systems - VOCSN+Pro package, REF: PRT-00853-000
FDA Device · Class II · 2026-07-01 · Ventec Life Systems - VOCSN V+Pro package, REF: PRT-01198-000
FDA Device · Class I · 2026-05-13 · Ventec Life Systems - VOCSN Multi-Function Ventilators: VOCSN+Pro (V+O+C+S+N+Pro, English), REF: PRT-00490-001
FDA Device · Class I · 2025-03-05 · Ventec Life Systems
All Ventec Life Systems recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3222-2026%22
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