FDA recall Z-2525-2026

Product

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.

Distribution

US Nationwide distribution in the state of UT.

Key facts

Status

Ongoing

Initiation date

2026-05-08

Report date

2026-07-01

Voluntary/Mandated

Voluntary: Firm initiated

Location

Bothell, WA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2525-2026