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U.S. Department of Health and Human Services

Class 2 Device Recall HomeFill Oxygen System

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 Class 2 Device Recall HomeFill Oxygen Systemsee related information
Date Initiated by FirmJuly 28, 2026
Date PostedSeptember 18, 2026
Recall Status1 Open3, Classified
Recall NumberZ-3223-2026
Recall Event ID 99660
Product Classification Cylinder, compressed gas, and valve - Product Code ECX
ProductREF: HF2POSTD HomeFill Oxygen System HomeFill cylinder D with CGA870 Compatible Post Valve
Code Information 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
FEI Number 3013095415
Recalling Firm/
Manufacturer		 Ventec Life Systems, Inc.
22002 26th Ave Se
Bothell WA 98021-4903
For Additional Information ContactGeorge Koos
1-863-2266285
Manufacturer Reason
for Recall		Labeling; Oxygen Cylinders do not contain required medical gas labeling
FDA Determined
Cause 2		Process control
ActionOn 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 Commerce25 units
DistributionUS Nationwide distribution in the states of FL, IA, OH, NE, TN.
Total Product Life CycleTPLC 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.
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