Z-2525-2026 Class II Ongoing
FDA device recall Z-2525-2026 was initiated by Ventec Life Systems, Inc. on May 8, 2026 and is designated Class II. 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 activat… The recall status is ongoing. Affected quantity: 1.
Recall Details
- Product Type
- Devices
- Report Date
- July 1, 2026
- Initiation Date
- May 8, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1
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.
Distribution Pattern
US Nationwide distribution in the state of UT.
Code Information
REF/UDI-DI/Serial Number/Lot: PRT-00853-000/00855573007839/155391P/807138, PRT-00490-001/00855573007792/155391/804613