Ventec Life Systems, Inc.: Continuous, Ventilator, Home Use
- Recalling firm
- 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
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-03-25
- Status
- Open, Classified
- Areas affected
- CA, GA, MO, OH
- Distribution
- US: OH, GA, CA, MO
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/535d78b5-bcc5-43b4-8c6b-17502475e246