VOCSN V+Pro package — Class I medical device recall Z-1942-2026
Ongoing recall by Ventec Life Systems, Inc., reported 2026-05-13, distributed in CA, GA, MO, OH. Respiratory system intended to provide continuous/intermittent ventilator support, may not have been evaluated
| Recall number | Z-1942-2026 |
|---|---|
| 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 | 2026-03-25 |
| Classified | 2026-05-01 |
| Reported by FDA | 2026-05-13 |
| Distributed | CA, GA, MO, OH |
| Quantity | 42 |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 00855573007877, 00855573007914 |
| Model numbers | PRT-01185-000, PRT-01198-000 |
Product
VOCSN V+Pro package, REF: PRT-01198-000; VOCSN V+Pro unit, REF: PRT-01185-000
Reason for recall
Respiratory system intended to provide continuous/intermittent ventilator support, may not have been evaluated under all intended high-pressure conditions during production testing, so an oxygen leak condition could occur that may lead to reduced below intended levels of fraction of inspired oxygen delivery prior to and during ventilation and this oxygen-enriched environment may increase fire risk
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-1942-2026. 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.