- Recalling firm
- Ventec Life Systems, Inc.
- 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
- Affected products (lot / model / serial)
- 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
- Units affected
- 42
- Distribution pattern
- US: OH, GA, CA, MO
- Firm location
- Bothell, WA, United States
- Recall type
- Voluntary: Firm initiated
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-1942-2026
- Recall initiated
- March 25, 2026
- FDA classification date
- May 1, 2026
- FDA report date
- May 13, 2026
- FDA event ID
- 98554
- Last updated on HTM Vibe
- July 24, 2026