CLASS I ONGOING Device recall · Reported 5 Mar 2025 · FDA Enforcement Report
Vocsn Multi-Function Ventilators: Vocsn+Pro (V+O+C+S+N+Pro, English) recalled
Ventec Life Systems is recalling Vocsn Multi-Function Ventilators: Vocsn+Pro (V+O+C+S+N+Pro, English), distributed in California, Missouri, New York. The recall was initiated on 3 Feb 2025 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-1196-2025
- FDA event ID
- 96136
- Recalling firm
- Ventec Life Systems, Bothell, WA
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 3 Feb 2025
- FDA classified
- 26 Feb 2025
- Reported
- 5 Mar 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Labeling Errors
- Device type
- CPAP & Ventilators
Timeline
| 3 Feb 2025 | Recall initiated by company | |
| 26 Feb 2025 | Classified by FDA | +23 days |
| 5 Mar 2025 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Multi-Function Ventilators were serviced using incorrect parts which have the potential to cause unexpected shutdown, or when using an active circuit could result in inaccurate tidal volume monitor, not triggering on patient efforts, less inspiratory volume, less inspiratory pressure, and less PEEP delivered.
Product as listed by the FDA
VOCSN Multi-Function Ventilators: VOCSN+Pro (V+O+C+S+N+Pro, English), REF: PRT-00490-001; V+Pro (V+Pro, English), REF: PRT-01185-000, PRT-01185-002
Where it was distributed
US distribution in CA, NY, and MO.
Questions about this recall
Why was it recalled?
Multi-Function Ventilators were serviced using incorrect parts which have the potential to cause unexpected shutdown, or when using an active circuit could result in inaccurate tidal volume monitor, not triggering on patient efforts, less inspiratory volume, less inspiratory pressure, and less PEEP delivered.
Which lots are affected?
REF/UDI-DI/Serial Numbers: PRT-00490-001/00855573007792/123627, 121892, 119639; PRT-01185-000/00855573007877/5038421, 116700, 117933, 5038112, 5038619, 5038717, 5038953, 5039086, 5039091, 5039361, 5039499, 5039503, 5039541, 5039636, 5039938, 5040019, 5040640, 5040762, 5041060, 5041078, 5041534, 5042558, 117344, 118464, 118509, 5039387; PRT-01185-002/00850018761154/5037655
Where was it sold?
US distribution in CA, NY, and 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.
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