Ventilator Recall: Ventec VOCSN V+Pro
Announced 2026-07-01 · FDA
Ventec Life Systems VOCSN V+Pro package and VOCSN V+Pro unit are recalled due to an oxygen leak that could reduce the delivered fraction of inspired oxygen before and during ventilation, potentially increasing fire risk in an oxygen-enriched environment. The recall covers 42 devices distributed in OH, GA, CA, and MO.
| Brand | Ventec Life Systems, Inc. |
|---|---|
| Product | VOCSN V+Pro package, REF: PRT-01198-000; VOCSN V+Pro unit, REF: PRT-01185-000 |
| Reason | 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 |
| Severity | critical |
| Units affected | 1 |
| Distribution | US: OH, GA, CA, MO |
| Agency | FDA |
| Recall / campaign no. | 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 |
WHAT YOU SHOULD DO
- Stop using the affected devices until they have been inspected or repaired.
- Contact Ventec Life Systems or your equipment supplier to arrange inspection, repair, or replacement, and verify if your device is included in this recall.
- Follow your clinician's guidance and ensure safety practices around oxygen; report any alarms or safety concerns to the provider.
This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.