Class 2 Device Recall HomeFill Oxygen System

• Date Initiated by Firm: July 28, 2026
• Date Posted: September 18, 2026
• Recall Status: Open, Classified
• Recall Number: Z-3222-2026
• Recall Event ID: 99660
• Product Classification: Cylinder, compressed gas, and valve - Product Code ECX
• Product: REF:HF2PC9 HomeFill Oxygen System, HomeFill Cylinder M9 with Integrated Conserver
• Code Information: UDI:00850018761352/Serial #s: 24IKMA0029J and 24IKMA002CM
• FEI Number: 3013095415
• Recalling Firm/ Manufacturer: Ventec Life Systems, Inc.; 22002 26th Ave Se; Bothell WA 98021-4903
• For Additional Information Contact: George Koos; 1-863-2266285
• Manufacturer Reason for Recall: Labeling; Oxygen Cylinders do not contain required medical gas labeling
• FDA Determined 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 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.
• Quantity in Commerce: 2 units
• Distribution: US Nationwide distribution in the states of FL, IA, OH, NE, TN.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.