REF:HF2PC9 HomeFill Oxygen System, HomeFill Cylinder M9 with Integrated Conserver
Summary
The FDA issued a Class II for REF:HF2PC9 HomeFill Oxygen System, HomeFill Cylinder M9 with Integrated Conserv by Ventec Life Systems, Inc.. Reason: Labeling; Oxygen Cylinders do not contain required medical gas labeling.
Details
Source
Device Recall
External ID
Z-3222-2026
Action Date
2026-09-30
Status
Ongoing
Category
device
Product Description
REF:HF2PC9 HomeFill Oxygen System, HomeFill Cylinder M9 with Integrated Conserver
Lot/Code Info: UDI:00850018761352/Serial #s: 24IKMA0029J and 24IKMA002CM
Quantity Affected: 2 units
Reason for Recall
Labeling; Oxygen Cylinders do not contain required medical gas labeling
Distribution
US Nationwide distribution in the states of FL, IA, OH, NE, TN.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-07-28
Company
Bothell, WA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 196 device recalls issued in the same week, part of 445 device-related FDA actions this month.
Ventec Life Systems, Inc. has 7 FDA actions in our database, including 7 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Ventec Life Systems, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Ventec Life Systems, Inc. have FDA actions?
Ventec Life Systems, Inc. has 7 FDA actions in our database, including 7 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-3222-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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