VOCSN Multi-Function Ventilators: VOCSN+Pro — Class I medical device recall Z-1196-2025
Ongoing recall by Ventec Life Systems, Inc., reported 2025-03-05, distributed in CA, MO, NY. Multi-Function Ventilators were serviced using incorrect parts which have the potential to cause unexpected sh
| Recall number | Z-1196-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ventec Life Systems, Inc., Bothell, WA, United States |
| Recall initiated | 2025-02-03 |
| Classified | 2025-02-26 |
| Reported by FDA | 2025-03-05 |
| Distributed | CA, MO, NY |
| Quantity | 30 |
| UPC / GTIN / UDI-DI | 00850018761154, 00855573007792, 00855573007877 |
| Serial numbers | 116700, 117344, 117933, 118464, 118509, 119639, 121892, 5038112, 5038619, 5038717, 5038953, 5039086, 5039091, 5039361, 5039387, 5039499, 5039503, 5039541, 5039636, 5039938, 5040019, 5040640, 5040762, 5041060, 5041078 and 2 more |
| Model numbers | PRT-00490-001, PRT-01185-000, PRT-01185-002 |
Product
VOCSN Multi-Function Ventilators: VOCSN+Pro (V+O+C+S+N+Pro, English), REF: PRT-00490-001; V+Pro (V+Pro, English), REF: PRT-01185-000, PRT-01185-002
Reason for recall
Multi-Function Ventilators were serviced using incorrect parts which have the potential to cause unexpected shutdown, or when using an active circuit could result in inaccurate tidal volume monitor, not triggering on patient efforts, less inspiratory volume, less inspiratory pressure, and less PEEP delivered.
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-1196-2025. 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.