REF:HF2PC9 HomeFill Oxygen System recall (Ventec Life Systems, Inc.)
Medical deviceClass IIOngoing
Summary: Ventec Life Systems, Inc. is recalling REF:HF2PC9 HomeFill Oxygen System, HomeFill Cylinder M9 with Integrated Conserver. Reason: Labeling; Oxygen Cylinders do not contain required medical gas labeling.
What is being recalled
REF:HF2PC9 HomeFill Oxygen System, HomeFill Cylinder M9 with Integrated Conserver
Why
Labeling; Oxygen Cylinders do not contain required medical gas labeling
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
US Nationwide distribution in the states of FL, IA, OH, NE, TN. (states named: Florida, Iowa, Nebraska, Ohio, Tennessee)
How to tell if yours is affected
UDI:00850018761352/Serial #s: 24IKMA0029J and 24IKMA002CM
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-3222-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | July 28, 2026 |
| Reported | September 30, 2026 |
| Company | Ventec Life Systems, Inc. |
| Company location | Bothell, WA, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 2 units |
More recalls from Ventec Life Systems, Inc. · all medical device recalls · recalls from July 2026