Ventec recalls VOCSN V+Pro ventilators over possible oxygen leak that could cause low oxygen delivery and fire risk
Production testing may not have covered all high-pressure conditions, so an oxygen leak could occur, giving patients less oxygen than intended and making fire more likely in the oxygen-enriched air.
What to do
The notice does not give instructions. Read the official notice for details.
Recall details
- Product
- VOCSN V+Pro package, REF: PRT-01198-000; VOCSN V+Pro unit, REF: PRT-01185-000
- Company
- Ventec Life Systems, Inc.
- Hazard
- 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
- Units
- 42
- Where sold
- US: OH, GA, CA, MO
- FDA classification
- Class I · Ongoing
- Classified by FDA
- May 1, 2026
- Recall started
- March 25, 2026
- FDA enforcement report
- May 13, 2026
- Identifiers
- Codes: 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
- FDA recall number: Z-1942-2026
The headline, summary and steps above are written in plain English from the official notice below. Identifiers are copied exactly as the agency published them. Always check the official notice before you act.
Official notice
The notice's own wording from FDA.
- Product
- VOCSN V+Pro package, REF: PRT-01198-000; VOCSN V+Pro unit, REF: PRT-01185-000
- 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
- Classification
- Class I (Ongoing)
- Distribution
- US: OH, GA, CA, MO
- Quantity
- 42
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