VOCSN+Pro package — Class II medical device recall Z-2525-2026
Ongoing recall by Ventec Life Systems, Inc., reported 2026-07-01, distributed nationwide. Respiratory system intended to provide continuous/intermittent ventilator support, may have a damaged back-up
| Recall number | Z-2525-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ventec Life Systems, Inc., Bothell, WA, United States |
| Recall initiated | 2026-05-08 |
| Classified | 2026-06-23 |
| Reported by FDA | 2026-07-01 |
| Distributed | Nationwide (US) |
| Quantity | 1 |
| UPC / GTIN / UDI-DI | 00855573007792, 00855573007839 |
| Model numbers | PRT-00490-001, PRT-00853-000 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2525-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.