VOCSN V+Pro package, REF: PRT-01198-000; VOCSN V+Pro unit, REF: PRT-01185-000

FDA device recall Z-1942-2026 · posted 2026-05-01 · Open, Classified

Recall details

Recalling firm

Ventec Life Systems, Inc.

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

Action taken

On 3/25/2026 recall notices were mailed to customers who were asked to do the following: 1. Immediately discontinue use of affected devices. 2. Inspect current stock, quarantine/segregate any unused affected products, remove affected devices from clinical service and segregate to prevent further use. 3. Use a non-affected ventilator for patient support. 4. If you have distributed or transferred affected devices to other facilities, caregivers, or end users, you must promptly notify them of this recall and provide a copy of this notification. 5. Complete and return the response form via email to Ventec-Recall@reacthealth.com 6. If you are no longer the owner of any of these devices, you need to complete an ownership transfer form at: VentecLife.com/tracking so firm can follow up with the current owner of the impacted device(s). If you have questions, you can contact the firm at 844-698-6276

Root cause

Process change control

Status

Open, Classified

Product code

NOU

Quantity affected

42

Distribution

US: OH, GA, CA, MO

Date initiated

2026-03-25

Date posted

2026-05-01

Location

Bothell, WA

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