FDA Device recall Z-2525-2026
VOCSN+Pro package, REF: PRT-00853-000
- FDA Device
- Class II
- ongoing
- Published 2026-07-01
On 2026-07-01 the FDA classified a Class II recall of VOCSN+Pro package, REF: PRT-00853-000 by Ventec Life Systems, citing 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 bac….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2525-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-05-08 |
| Published | 2026-07-01 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Ventec Life Systems |
| Distribution | US |
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.
Identifiers
| code_info | REF/UDI-DI/Serial Number/Lot: PRT-00853-000/00855573007839/155391P/807138, PRT-00490-001/00855573007792/155391/804613 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2525-2026%22
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