Recall Z-1942-2026— Ventec Life Systems, Inc.
Class I · Ongoing
Class I FDA medical device recall by Ventec Life Systems, Inc., initiated 2026-03-25. It names one FDA 510(k) clearance: K162877. 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.
- Recalling firm
- Ventec Life Systems, Inc.
- Classification
- Class I
- Status
- Ongoing
- Initiated
- 2026-03-25
- Firm location
- Bothell, WA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.