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HF2P0ST9 HomeFill Oxygen System HomeFill Cylinder M9 with CGA870 Compatible Post Valve

Class II
Recalling firm
Ventec Life Systems, Inc.
Reason for recall
Labeling; Oxygen Cylinders do not contain required medical gas labeling
Affected products (lot / model / serial)
UDI:00850018761369/Serial #s: 24IKMA00532 24IKMA0053M 24IKMA0054N 24IKMA005G8 24IKMA005AP 24IKMA005QB 24IKMA005Q4 24IKMA005PM 24IKMA005QJ 24IKMA005QX 24IKMA005PJ 24IKMA005SW 24IKMA005RB 24IKMA00612 24IKMA0067E 24IKMA0066L 24IKMA0068U 24IKMA00685 24IKMA006AQ 24IKMA006B7 24IKMA006BG
Units affected
21 units
Distribution pattern
US Nationwide distribution in the states of FL, IA, OH, NE, TN.
Firm location
Bothell, WA, United States
Recall type
Voluntary: Firm initiated
How the firm notified customers
Letter
Product type
Devices
Status
Ongoing
Recall number
Z-3221-2026
Recall initiated
July 28, 2026
FDA classification date
September 18, 2026
FDA report date
September 30, 2026
FDA event ID
99660
Last updated on HTM Vibe
October 6, 2026
View on openFDA