FDAFDA recall Z-3221-2026 · Sep 30, 2026
Ventec Life Systems, Inc.: HF2P0ST9 HomeFill Oxygen System HomeFill Cylinder M9 with CGA870 Compatible Post Valve recall
Recall found
Product
HF2P0ST9 HomeFill Oxygen System HomeFill Cylinder M9 with CGA870 Compatible Post Valve
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:00850018761369/Serial #s: 24IKMA00532 24IKMA0053M 24IKMA0054N 24IKMA005G8 24IKMA005AP 24IKMA005QB 24IKMA005Q4 24IKMA005PM 24IKMA005QJ 24IKMA005QX 24IKMA005PJ 24IKMA005SW 24IKMA005RB 24IKMA00612 24IKMA0067E 24IKMA0066L 24IKMA0068U 24IKMA00685 24IKMA006AQ 24IKMA006B7 24IKMA006BG
- Quantity
- 21 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-3221-2026 · search recall number Z-3221-2026 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.