FDA Medical devices recall ·
REF:HF2PC9 HomeFill Oxygen System, HomeFill Cylinder M9 with Integrated… recall
- Recall number
- Z-3222-2026
- 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
- 2 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
REF:HF2PC9 HomeFill Oxygen System, HomeFill Cylinder M9 with Integrated Conserver
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:00850018761352/Serial #s: 24IKMA0029J and 24IKMA002CM
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-3222-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.