CLASS I ONGOING Device recall · Reported 13 May 2026 · FDA Enforcement Report
Vocsn V+Pro package recalled by Ventec Life Systems
Ventec Life Systems is recalling Vocsn V+Pro package, distributed in California, Georgia, Missouri, Ohio. The recall was initiated on 25 Mar 2026 and the FDA has classified it as Class I.
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-1942-2026
- FDA event ID
- 98554
- Recalling firm
- Ventec Life Systems, Bothell, WA
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 25 Mar 2026
- FDA classified
- 1 May 2026
- Reported
- 13 May 2026
- Type
- Voluntary: Firm initiated
- Reason category
- Packaging Defects
- Device type
- Other Medical Devices
Timeline
| 25 Mar 2026 | Recall initiated by company | |
| 1 May 2026 | Classified by FDA | +37 days |
| 13 May 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
Respiratory system intended to provide continuous/intermittent ventilator support, may not have been evaluated under all intended high-pressure conditions during production testing, so an oxygen leak condition could occur that may lead to reduced below intended levels of fraction of inspired oxygen delivery prior to and during ventilation and this oxygen-enriched environment may increase fire risk
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
VOCSN V+Pro package, REF: PRT-01198-000; VOCSN V+Pro unit, REF: PRT-01185-000
Where it was distributed
US: OH, GA, CA, MO
Questions about this recall
Why was it recalled?
Respiratory system intended to provide continuous/intermittent ventilator support, may not have been evaluated under all intended high-pressure conditions during production testing, so an oxygen leak condition could occur that may lead to reduced below intended levels of fraction of inspired oxygen delivery prior to and during ventilation and this oxygen-enriched environment may increase fire risk
Which lots are affected?
UDI-DI (REF/UDI-DI): PRT-01198-000/00855573007914, PRT-01185-000/00855573007877 Package/Device Serial Number (package serial number may include a "P" at the end): 152884, 152885, 152886, 152887, 152888, 152889, 152890, 152891, 152892, 152893, 152895, 152896, 152897, 152898, 152899, 152900, 152901, 152902, 152903, 152904, 152908, 152909, 152910, 152911, 152912, 152913, 152914, 152915, 152916, 152917, 152918, 152919, 152986, 152987, 155236, 156507, 156512, 156515, 156516, 156517, 156524, 156532
Where was it sold?
US: OH, GA, CA, MO
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 I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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:HF2PC9 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 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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