FDA-Device2026-09-30Class IIMISBRANDING
Ventec Life Systems HomeFill Oxygen Cylinder M9 recalled for missing required medical gas labeling
What this means
Ventec Life Systems' HomeFill Cylinder M9 units lack required medical gas labeling on the cylinders themselves. This labeling is a safety requirement that helps users and healthcare providers identify the contents and proper handling of the oxygen cylinders. Two units with specific serial numbers were affected.
- Check your HomeFill system serial number against 24IKMA0029J and 24IKMA002CM
- If your cylinder matches, contact Ventec Life Systems for instructions on a replacement or corrective label
- Do not rely solely on the system itself to identify cylinder contents; verify with your supplier or provider
The agency's original wording
Hazard
Labeling; Oxygen Cylinders do not contain required medical gas labeling
Intended for
Adults
Illnesses reported
None reported
Sold states
US Nationwide distribution in the states of FL, IA, OH, NE, TN.
Affected count
2 units
Manufactured in
22002 26th Ave Se, Bothell, WA, United States
Products
REF:HF2PC9 HomeFill Oxygen System, HomeFill Cylinder M9 with Integrated Conserver
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3222-2026More Ventec Life Systems recalls
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