FDA Recall Open, Classified

VOCSN+Pro package, REF: PRT-00853-000; VOCSN+Pro unit, REF: PRT-00490-001

Recall: Z-2525-2026 · Initiated May 8, 2026

Recall

Recall Number
Z-2525-2026
Event Number
98888
Firm
Ventec Life Systems, Inc.
FEI Number
3013095415
Product Code
CBK
Status
Open, Classified
Root Cause
Vendor change control
Initiated
May 8, 2026
Posted
June 23, 2026
Address
22002 26th Ave Se, Bothell, WA, 98021-4903

Description

VOCSN+Pro package, REF: PRT-00853-000; VOCSN+Pro unit, REF: PRT-00490-001

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.

Action

On 5/8/2026, 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 an unaffected 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) Confirm receipt of this notification letter by returning the enclosed Customer Response Form via email to [email protected] Upon receipt of the Customer Response Form, firm will arrange for repair of existing device(s). Return the affected product to React Health If you have any questions, please contact firm at 844-698-6276.

Distribution

US Nationwide distribution in the state of UT.

Quantity

1