CLASS II ONGOING Device recall · Reported 30 Sep 2026 · FDA Enforcement Report
REF:HF2PC9 HomeFill Oxygen System, HomeFill Cylinder M9 recalled
Ventec Life Systems is recalling REF:HF2PC9 HomeFill Oxygen System, HomeFill Cylinder M9 with, 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
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-3222-2026
- 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
REF:HF2PC9 HomeFill Oxygen System, HomeFill Cylinder M9 with Integrated Conserver
Where it was distributed
US Nationwide distribution in the states of FL, IA, OH, NE, TN.
Questions about this recall
Why was it recalled?
Labeling; Oxygen Cylinders do not contain required medical gas labeling
Which lots are affected?
UDI:00850018761352/Serial #s: 24IKMA0029J and 24IKMA002CM
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 99660This 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 |
|---|---|---|---|---|---|
| CLASS II | REF: HF2POSTD HomeFill Oxygen System HomeFill cylinder D with CGA870 recalled | Ventec Life Systems | Other | Nationwide | |
| CLASS II | HF2P0ST9 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 |
|---|---|---|---|---|---|
| Device | CLASS II | HF2P0ST9 HomeFill Oxygen System HomeFill Cylinder M9 recalled | Ventec Life Systems | Other | Nationwide |
| Device | CLASS II | REF: HF2POSTD HomeFill Oxygen System HomeFill cylinder D with CGA870 recalled | Ventec Life Systems | Other | Nationwide |
| Device | CLASS II | Vocsn+Pro package recalled by Ventec Life Systems | Ventec Life Systems | Device Malfunction | Nationwide |
| Device | CLASS I | Vocsn V+Pro package recalled by Ventec Life Systems | Ventec Life Systems | Packaging Defects | 4 states |
| Device | 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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|---|---|---|---|---|---|
| Device | CLASS II | Medline Convenience Kits: Major Pack recalled by Medline Industries | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline Convenience Kits: Peds Sinus Pack recalled by Medline Industries | Medline Industries | Other | Nationwide |
| Device | CLASS II | SmartPath to dStream for XR and 3.0T recalled by Philips North America | Philips North America | Device Malfunction | Nationwide |
| Device | CLASS II | Achieva 1.5T, Achieva 1.5T Conversion recalled by Philips North America | Philips North America | Device Malfunction | Nationwide |
| Device | CLASS II | Medline Convenience Kits: Mfc Craniotomy Pack recalled | Medline Industries | Other | Nationwide |