fda_recall · device_recall · critical
Ventec Life Systems, Inc. — Class I recall: VOCSN V+Pro package, REF: PRT-01198-000; VOCSN V+Pro unit, REF: PRT-01185-000
- Event date
- 2026-05-13 00:00:00Z
- Observed
- 2026-07-09 22:52:36Z
- Source ID
- Z-1942-2026
- Payload hash
- fd73a4381763a28353362b6f…
Summary
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… Status: Ongoing.
Entities
Informational only. Not legal, financial, or medical advice.