FDA-Device2026-09-30Class IIMISBRANDING

Ventec Life Systems HomeFill Oxygen Cylinder M9 recalled for missing medical gas labeling

LABEL MIX UPNationwide distributionMedical devices

What this means

Ventec Life Systems HomeFill Cylinder M9 oxygen cylinders lack required medical gas labeling on the product. These cylinders were distributed in Florida, Iowa, Ohio, Nebraska, and Tennessee. Without proper labeling, users may not have complete safety and product information.

  • If you have a HomeFill Cylinder M9 with one of the affected serial numbers listed (24IKMA00532 through 24IKMA006BG), contact Ventec Life Systems for instructions.
  • Do not use the cylinder if labeling is illegible or missing.
  • Contact your home oxygen supplier or equipment provider for a replacement or corrected unit.
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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
21 units
Manufactured in
22002 26th Ave Se, Bothell, WA, United States
Products
HF2P0ST9 HomeFill Oxygen System HomeFill Cylinder M9 with CGA870 Compatible Post Valve

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3221-2026

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