Recall Z-2525-2026— Ventec Life Systems, Inc.

Name: FDA recall Z-2525-2026
Creator: U.S. Food and Drug Administration
Published: 2026-05-08

Class II · Ongoing

Class II FDA medical device recall by Ventec Life Systems, Inc., initiated 2026-05-08. It names one FDA 510(k) clearance: K162877. Product: 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..

Recalling firm: Ventec Life Systems, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2026-05-08
Firm location: Bothell, WA, United States

510(k) clearances named in this recall

1 on FDA's record

K162877 — VOCSN Unified Respiratory SystemVentec Life Systems, Inc.·cleared 2017-04-07

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.