Recall Z-1942-2026

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

FDA-determined cause: Process change control

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