Recall Ledger

HF2P0ST9 HomeFill Oxygen System HomeFill Cylinder M9 with CGA870 Compatible Post Valve recall (Ventec Life Systems, Inc.)

Medical deviceClass IIOngoing

Summary: Ventec Life Systems, Inc. is recalling HF2P0ST9 HomeFill Oxygen System HomeFill Cylinder M9 with CGA870 Compatible Post Valve. Reason: Labeling; Oxygen Cylinders do not contain required medical gas labeling.

What is being recalled

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

Why

Labeling; Oxygen Cylinders do not contain required medical gas labeling

How serious is it

Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.

Where it was sold

US Nationwide distribution in the states of FL, IA, OH, NE, TN. (states named: Florida, Iowa, Nebraska, Ohio, Tennessee)

How to tell if yours is affected

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

What to do

Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.

Recall facts

Recall numberZ-3221-2026
CategoryMedical device
AgencyU.S. Food and Drug Administration (FDA)
SeverityClass II
StatusOngoing
Recall startedJuly 28, 2026
ReportedSeptember 30, 2026
CompanyVentec Life Systems, Inc.
Company locationBothell, WA, United States
Initiated byVoluntary: Firm initiated
Quantity21 units

More recalls from Ventec Life Systems, Inc. · all medical device recalls · recalls from July 2026

Official FDA record