Recall Z-3221-2026 ยท ECX Cylinder, Compressed Gas, And Valve
Ventec Life Systems, Inc.
HF2P0ST9 HomeFill Oxygen System HomeFill Cylinder M9 with CGA870 Compatible Post Valve
| Date | Sep 18, 2026 (initiated Jul 28, 2026) |
| Status | Open, Classified |
| Reason | Labeling; Oxygen Cylinders do not contain required medical gas labeling |
| Root cause | Process control |
| Action | On July 28, 2026, Ventec Life Systems Inc. issued a Urgent: Medical Device Recall notification to affected consignees via: certified mail. Ventec ask consignees to take the following actions: 1. Immediately discontinue use of affected HomeFill Oxygen Cylinders. 2. Inspect current stock, quarantine/segregate any unused affected products, remove affected product from clinical service and segregate to prevent further use until the enclosed label correction has been completed. 3. Use an unaffected oxygen cylinder for patient support. 4. If you have distributed or transferred affected product to |
| Quantity | 21 units |
| Distribution | US Nationwide distribution in the states of FL, IA, OH, NE, TN. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.