HomeFill Oxygen System recallZ-3221-2026 · Ventec Life Systems, Inc. · initiated Jul 28, 2026
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Ventec Life Systems, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Labeling; Oxygen Cylinders do not contain required medical gas labeling
FDA root cause category: Process control
What the company is doing
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 other facilities, caregivers, or end users, you must promptly notify them of this recall and provide a copy of this notification. 5.. Confirm receipt of this notification letter by returning the enclosed Customer Response Form to React Health WITHIN 7 DAYS OF RECEIPT. 6. Upon receipt of the Customer Response Form, React Health will arrange for shipment of the label and instructions to apply the label to affected cylinders along with an update confirmation letter. 7. Update the affected product and return the completed confirmation letter to React Health. Contact Customer Support at 863-226 -6285 to discuss completing the form, if necessary.
Recall details
- Recall number
- Z-3221-2026
- Status
- Open, Classified
- Initiated by the company
- Jul 28, 2026
- Posted by the FDA
- Sep 18, 2026
- Recalling firm
- Ventec Life Systems, Inc.
- Quantity
- 21 units
- Product code
- ECX
- Distribution
- US Nationwide distribution in the states of FL, IA, OH, NE, TN.
Product description
HF2P0ST9 HomeFill Oxygen System HomeFill Cylinder M9 with CGA870 Compatible Post Valve
Code information (models, lots, serial 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
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- HomeFill® Oxygen System HF2POST9Ventec Life Systems, Inc. · Generator, Oxygen, Portable1 recall0 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 99660).
- Z-3222-2026 · Open, ClassifiedREF:HF2PC9 HomeFill Oxygen System, HomeFill Cylinder M9 with Integrated Conserver
- Z-3223-2026 · Open, ClassifiedREF: HF2POSTD HomeFill Oxygen System HomeFill cylinder D with CGA870 Compatible Post Valve
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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