HomeFill Oxygen System recallZ-3223-2026 · Ventec Life Systems, Inc. · initiated Jul 28, 2026
Class II Open, Classified All recalls posted in September 2026
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-3223-2026
- Recall class
- Class II
- Status
- Open, Classified
- Initiated by the company
- Jul 28, 2026
- Posted by the FDA
- Sep 18, 2026
- Recalling firm
- Ventec Life Systems, Inc.
- Quantity
- 25 units
- Product code
- ECX
- Distribution
- US Nationwide distribution in the states of FL, IA, OH, NE, TN.
Product description
REF: HF2POSTD HomeFill Oxygen System HomeFill cylinder D with CGA870 Compatible Post Valve
Code information (models, lots, serial numbers)
UDI:00850018761376/ Serial #s: 25EKMA00BAC 25EKMA009L3 25EKMA009CM 25EKMA009J8 25GKMA00077 25GKMA0007B 25GKMA0009Z 25GKMA0004U 25GKMA000CS 25GKMA000CR 25GKMA000CX 25GKMA000D0 25GKMA000LL 25GKMA000N1 25GKMA000UD 25GKMA000D1 25GKMA000TN 25GKMA000D2 25GKMA000UC 25GKMA000LK 25GKMA000UA 25GKMA000UB 25GKMA000UE 25GKMA000CY 25GKMA000UF
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- HomeFill® Oxygen System HF2POSTDVentec 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-3221-2026 · Open, ClassifiedHF2P0ST9 HomeFill Oxygen System HomeFill Cylinder M9 with CGA870 Compatible Post Valve
- Z-3222-2026 · Open, ClassifiedREF:HF2PC9 HomeFill Oxygen System, HomeFill Cylinder M9 with Integrated Conserver
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 18, 2026. Text above is shown as published by the FDA.
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