Bothell, WA, United States
Ventec Life Systems, Inc. recalls
6 recalls recorded since 2018, most recently on 28 July 2026. 6 are listed as ongoing. Status and classification are as published by the FDA.
Recalls6
Ongoing (FDA)6
Terminated or completed0
Class I (FDA)3
Ongoing Class II Medical devices
- Recall started
- 28 July 2026
- Reason
- Labeling; Oxygen Cylinders do not contain required medical gas labeling
- Distribution
- US Nationwide distribution in the states of FL, IA, OH, NE, TN.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-3223-2026, Z-3222-2026, Z-3221-2026
- REF: HF2POSTD HomeFill Oxygen System HomeFill cylinder D with CGA870 Compatible Post Valve
- REF:HF2PC9 HomeFill Oxygen System, HomeFill Cylinder M9 with Integrated Conserver
- HF2P0ST9 HomeFill Oxygen System HomeFill Cylinder M9 with CGA870 Compatible Post Valve
Ongoing Class II Medical devices
- Recall started
- 8 May 2026
- Reason
- Respiratory system intended to provide continuous/intermittent ventilator support, may have a damaged back-up battery supporting backup alarm function, which may result in the backup alarm not activating during loss of primary power and absence/depletion of backup power sources, which may result in delayed caregiver awareness of a hazardous condition.
- Distribution
- US Nationwide distribution in the state of UT.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2525-2026
- VOCSN+Pro package, REF: PRT-00853-000; VOCSN+Pro unit, REF: PRT-00490-001
Ongoing Class I Medical devices
- Recall started
- 25 March 2026
- 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
- Distribution
- US: OH, GA, CA, MO
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1942-2026
- VOCSN V+Pro package, REF: PRT-01198-000; VOCSN V+Pro unit, REF: PRT-01185-000
Ongoing Class I Medical devices
- Recall started
- 3 February 2025
- Reason
- Multi-Function Ventilators were serviced using incorrect parts which have the potential to cause unexpected shutdown, or when using an active circuit could result in inaccurate tidal volume monitor, not triggering on patient efforts, less inspiratory volume, less inspiratory pressure, and less PEEP delivered.
- Distribution
- US distribution in CA, NY, and MO.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1196-2025
- VOCSN Multi-Function Ventilators: VOCSN+Pro (V+O+C+S+N+Pro, English), REF: PRT-00490-001; V+Pro (V+Pro, English), REF: PRT-01185-000, PRT-01185-002
Ongoing Class I Medical devices
- Recall started
- 9 January 2024
- Reason
- The bonded spiral wrap may detach before or during ventilation due to a manufacturing issue. Detachment of the spiral wrap can compromise structural integrity, functionality and/ or performance resulting in occlusions or leaks of the breathing circuit which may cause serious injury or death. The risk of injury or death is increased for ventilator dependent patients.
- Distribution
- U.S.: CA, CO, FL, HI, IN, MO, NC, and WA O.U.S.: Japan
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1070-2024
- VOCSN Patient Breathing Package (Pediatric, Active, Oxygen, Blue) REF PRT-01013-000 with pouch REF PRT-00802-001). Used with the VOCSN Unified Respiratory System which provides continuous or intermittent ventilatory su
Ongoing Class II Medical devices
- Recall started
- 10 May 2021
- Reason
- Due to a component failure, ventilators may unexpectedly shut down or have a loss of blower function while in patient use. The shutdown potentially prevents the ventilator from providing ventilation therapy.
- Distribution
- Distribution US nationwide, Hong Kong, and Japan
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1902-2021
- Ventec Life Systems VOCSN Multi-Function Ventilator Model/Version/Catalog Number: V+O+C+S+N+Pro/English/PRT-00490-001; V+O+C+S+N+Pro/Japan/PRT-00490-100; V+C+Pro/English/PRT-00900-001; V+C+Pro/Japan/PRT-00900-100;
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.