FDA Medical devices recall ·
HF2P0ST9 HomeFill Oxygen System HomeFill Cylinder M9 with CGA870… recall
- Recall number
- Z-3221-2026
- Date
- (initiated July 28, 2026)
- Company / brand
- Ventec Life Systems, Inc.
22002 26th Ave Se, Bothell, WA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 21 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
HF2P0ST9 HomeFill Oxygen System HomeFill Cylinder M9 with CGA870 Compatible Post Valve
Why was it recalled?
Labeling; Oxygen Cylinders do not contain required medical gas labeling
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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
Distribution
US Nationwide distribution in the states of FL, IA, OH, NE, TN.
States: Florida Iowa Nebraska Ohio Tennessee
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-3221-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.