The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-0131-2027·Announced 2026-10-28

Ventec Ventilator Cable Connector Recall for Potential System Reboot

Ventec Life Systems is recalling 180 ventilator units 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 FDA Class I, and the source describes a hazard where the ventilator may reboot and interrupt therapy, but the source does not report any illnesses, injuries, or deaths.

Plain-English summary

Ventec Life Systems, Inc. is recalling 180 units of the VC(Japan) ventilator, Model Number PRT-01098-100, Package PN PRT-01125-100. These devices are used for ventilatory support. The recall covers units distributed nationwide in the United States, including Puerto Rico.

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 source text does not report any illnesses, injuries, or deaths associated with this defect.

Consumers and healthcare facilities should identify affected units by checking for UDI 00850018761116. The source text does not provide specific instructions for consumers or facilities on how to proceed with the recall or what alternative actions to take.

The recalled product

Product
VC(Japan) Model Number: PRT-01098-100, Package PN:PRT-01125-100. used for ventilatory support.
Manufacturer
Ventec Life Systems, Inc.
Category
Medical Device — Ventilator
Hazard
Affected units
180

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 (1)

  • All Serial Numbers: UDI: 00850018761116

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

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