Agency classClass IOur severity:Severe FDA (Devices)·Z-0123-2027·Announced 2026-10-28

Ventec VOCSN+Pro Ventilators Recalled for Potential Flow Transducer Cable Disconnection

Ventec Life Systems is recalling 325 VOCSN+Pro ventilators because an internal cable connector may disconnect, causing system reboots and interruption of ventilation therapy.

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: The recall is classified as Class I because the potential disconnection of the internal flow transducer cable connector may cause a system reboot and interruption of ventilation therapy, which presents a reasonable probability of serious adverse health consequences. The source does not report any illnesses, injuries, or deaths.

Plain-English summary

Ventec Life Systems, Inc. is recalling 325 units of the VOCSN+Pro (Japan) ventilator, Model Number PRT-00490-100, Package PN PRT-00853-100. These devices are used for ventilatory support. The recall involves specific serial numbers associated with UDI codes 00855573007761 and 00855573007204.

The recall is being issued because the ventilator's internal flow transducer cable connector may disconnect from the internal board. This disconnection can potentially result in a system reboot and an interruption of ventilation therapy. The affected units were distributed nationwide in the United States, including Puerto Rico.

Healthcare providers and consumers should check their devices against the provided serial numbers and UDI codes. If a device is affected, users should contact Ventec Life Systems for instructions on how to proceed with the recall and any necessary repairs or replacements.

The recalled product

Product: VOCSN+Pro (Japan), Model Number: PRT-00490-100, Package PN:PRT-00853-100. used for ventilatory support.
Manufacturer: Ventec Life Systems, Inc.
Category: Medical Device — Ventilators
Hazard: system-reboot
therapy-interruption
Affected units: 325

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 (2)

All Serial Numbers: UDI: 00855573007761
00855573007204

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Same manufacturer · Ventec Life Systems, Inc.

See all →

Severe
Ventec V+ Pro Emergency Ventilator Recalled for Potential Connector Disconnection
FDA (Devices) · 2026-10-28
Severe
Ventec Ventilator Cable Connector Recall for Potential System Reboot
FDA (Devices) · 2026-10-28
Severe
Ventec Life Systems Recalls VOCSN Ventilator Parts Due to Cable Disconnection
FDA (Devices) · 2026-10-28
Severe
Ventec VC+Pro Ventilator Recalled for Potential Connector Disconnection
FDA (Devices) · 2026-10-28
Severe
Ventec Ventilator Cable Recall Due to Potential Disconnection
FDA (Devices) · 2026-10-28

Same hazard · system reboot