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

FDA device recall Z-2525-2026 · posted 2026-06-23 · Open, Classified

Recall details

Recalling firm

Ventec Life Systems, Inc.

Reason for recall

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 taken

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 Ventec-Recall@reacthealth.com 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.

Root cause

Vendor change control

Status

Open, Classified

Product code

CBK

Quantity affected

1

Distribution

US Nationwide distribution in the state of UT.

Date initiated

2026-05-08

Date posted

2026-06-23

Location

Bothell, WA

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