Agency classClass IOur severity:Severe FDA (Devices)·Z-1196-2025·Announced 2025-03-05

Ventec VOCSN Ventilators Recalled Due to Incorrect Service Parts

Ventec Life Systems recalled VOCSN Multi-Function Ventilators (30 units in CA, NY, MO) due to incorrect parts used during service. Defects may cause unexpected shutdown or impaired respiratory monitoring and support.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: This is an FDA Class I recall without reported deaths or illnesses, which establishes a Severe (4) rating per regulatory guidance. The defect directly affects critical ventilator functions with potential for unexpected device shutdown and impaired respiratory support delivery.

Plain-English summary

Ventec Life Systems, Inc. has recalled VOCSN Multi-Function Ventilators, specifically the VOCSN+Pro and V+Pro models, distributed in the United States. The devices were serviced using incorrect parts during maintenance.

The incorrect parts create a risk of serious malfunction. Specifically, the ventilators may experience unexpected shutdown. The devices may also display inaccurate tidal volume monitoring, fail to trigger on patient breathing efforts, and deliver less inspiratory volume, less inspiratory pressure, and less PEEP (positive end-expiratory pressure) than clinically intended.

A total of 30 units have been identified and recalled. Distribution was limited to three states: California, New York, and Missouri. The affected units are identified by specific serial numbers and reference numbers provided by the manufacturer.

Healthcare providers and facilities with these ventilators should verify equipment serial numbers against the recall notice and contact Ventec Life Systems immediately to address the service defect.

The recalled product

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
Manufacturer: Ventec Life Systems, Inc.
Category: Medical Device — Respiratory / Ventilators
Hazard: unexpected-shutdown
inaccurate-monitoring
respiratory-insufficiency
Affected units: 30

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

REF/UDI-DI/Serial Numbers: PRT-00490-001/00855573007792/123627
121892
119639
PRT-01185-000/00855573007877/5038421
116700
117933
5038112
5038619
5038717
5038953
5039086
5039091
5039361
5039499
5039503
5039541
5039636
5039938
5040019
5040640

Distribution

Distributed in 3 states:

Same manufacturer · Ventec Life Systems, Inc.

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Same hazard · unexpected shutdown