Z-3221-2026Class II

HF2P0ST9 HomeFill Oxygen System HomeFill Cylinder M9 with CGA870 Compatible Post Valve

Name: Z-3221-2026 HF2P0ST9 HomeFill Oxygen System HomeFill Cylinder M9 with CGA870 Compatible Post Valve
Creator: Ventec Life Systems, Inc.
Published: 2026-07-28
License: https://open.fda.gov/license/

Ventec Life Systems, Inc. / initiated 2026-07-28 / Open, Classified

FDA source

Recall record

Recall number: Z-3221-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-07-28
Posted: 2026-09-18
Recalling firm: Ventec Life Systems, Inc.
Product: HF2P0ST9 HomeFill Oxygen System HomeFill Cylinder M9 with CGA870 Compatible Post Valve
Product code: ECX Cylinder, Compressed Gas, And Valve
Reason for recall: Labeling; Oxygen Cylinders do not contain required medical gas labeling
FDA 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 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: 21 units
Distribution: US Nationwide distribution in the states of FL, IA, OH, NE, TN.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3221-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3221-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-30	2026-09-18
Z-3222-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-30	2026-09-18
Z-3223-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-30	2026-09-18

Product code ECX

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-23. View this recall on fda.gov (opens on fda.gov)