FDAFDA recall Z-3222-2026 · Sep 30, 2026
Ventec Life Systems, Inc.: REF:HF2PC9 HomeFill Oxygen System recall
Recall found
Product
REF:HF2PC9 HomeFill Oxygen System, HomeFill Cylinder M9 with Integrated Conserver
Reason for recall
Labeling; Oxygen Cylinders do not contain required medical gas labeling
What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
- Status
- Ongoing
- Codes, lots and dates
- UDI:00850018761352/Serial #s: 24IKMA0029J and 24IKMA002CM
- Quantity
- 2 units
- Distribution
- US Nationwide distribution in the states of FL, IA, OH, NE, TN.
- Recalling firm
- Ventec Life Systems, Inc., Bothell, WA
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-07-28
Source: openFDA enforcement record Z-3222-2026 · search recall number Z-3222-2026 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.