CLASS II ONGOING Device recall · Reported 30 Sep 2026 · FDA Enforcement Report

HF2P0ST9 HomeFill Oxygen System HomeFill Cylinder M9 recalled

Ventec Life Systems is recalling HF2P0ST9 HomeFill Oxygen System HomeFill Cylinder M9 with CGA870 Compatible Post Valve, distributed nationwide in the US. The recall was initiated on 28 Jul 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI:00850018761369/Serial #s: 24IKMA00532 24IKMA0053M 24IKMA0054N 24IKMA005G8 24IKMA005AP 24IKMA005QB 24IKMA005Q4 24IKMA005PM 24IKMA005QJ 24IKMA005QX 24IKMA005PJ 24IKMA005SW 24IKMA005RB 24IKMA00612 24IKMA0067E 24IKMA0066L 24IKMA0068U 24IKMA00685 24IKMA006AQ 24IKMA006B7 24IKMA006BG

Quantity recalled21 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-3221-2026
FDA event ID: 99660
Recalling firm: Ventec Life Systems, Bothell, WA
Classification: Class II
Status: Ongoing
Recall initiated: 28 Jul 2026
FDA classified: 18 Sep 2026
Reported: 30 Sep 2026
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

28 Jul 2026	Recall initiated by company
18 Sep 2026	Classified by FDA	+52 days
30 Sep 2026	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Labeling; Oxygen Cylinders do not contain required medical gas labeling

Product as listed by the FDA

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

Where it was distributed

US Nationwide distribution in the states of FL, IA, OH, NE, TN.

Nationwide Florida Iowa Nebraska Ohio Tennessee

Questions about this recall

Why was it recalled?

Labeling; Oxygen Cylinders do not contain required medical gas labeling

Which lots are 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

Where was it sold?

US Nationwide distribution in the states of FL, IA, OH, NE, TN.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 6 Oct 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

2 other products · FDA event 99660

This product is part of a recall event; the main page for the event is REF: HF2POSTD HomeFill Oxygen System HomeFill cylinder D with CGA870 recalled.

Reported	Class	Recall	Company	Reason	Where
30 Sep 2026	CLASS II	REF: HF2POSTD HomeFill Oxygen System HomeFill cylinder D with CGA870 recalled	Ventec Life Systems	Other	Nationwide
30 Sep 2026	CLASS II	REF:HF2PC9 HomeFill Oxygen System, HomeFill Cylinder M9 recalled	Ventec Life Systems	Other	Nationwide

More recalls from Ventec Life Systems

All 8

Reported	Class	Recall	Company	Reason	Where
30 Sep 2026Device	CLASS II	REF:HF2PC9 HomeFill Oxygen System, HomeFill Cylinder M9 recalled	Ventec Life Systems	Other	Nationwide
30 Sep 2026Device	CLASS II	REF: HF2POSTD HomeFill Oxygen System HomeFill cylinder D with CGA870 recalled	Ventec Life Systems	Other	Nationwide
1 Jul 2026Device	CLASS II	Vocsn+Pro package recalled by Ventec Life Systems	Ventec Life Systems	Device Malfunction	Nationwide
13 May 2026Device	CLASS I	Vocsn V+Pro package recalled by Ventec Life Systems	Ventec Life Systems	Packaging Defects	4 states
5 Mar 2025Device	CLASS I	Vocsn Multi-Function Ventilators: Vocsn+Pro (V+O+C+S+N+Pro, English) recalled	Ventec Life Systems	Labeling Errors	CA, MO, NY

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