Recall Z-3222-2026— Ventec Life Systems, Inc.

Class II · Ongoing

Class II FDA medical device recall by Ventec Life Systems, Inc., initiated 2026-07-28. FDA's recall record names no specific 510(k) clearance for this event. Product: REF:HF2PC9 HomeFill Oxygen System, HomeFill Cylinder M9 with Integrated Conserver. Reason: Labeling; Oxygen Cylinders do not contain required medical gas labeling.

Recalling firm
Ventec Life Systems, Inc.
Classification
Class II
Status
Ongoing
Initiated
2026-07-28
Firm location
Bothell, WA, United States

Product description

REF:HF2PC9 HomeFill Oxygen System, HomeFill Cylinder M9 with Integrated Conserver

Reason for recall

Labeling; Oxygen Cylinders do not contain required medical gas labeling

Data sourced from openFDA. This site is unofficial and independent of the FDA.