FDA Medical devices recall ·

V*Home, Model Number: PRT-01444-000, Package PN:PRT-01445-000… recall

This is an FDA Class I recall — the most serious type.

Recall number
Z-0133-2027
Date
(initiated September 17, 2026)
Company / brand
Ventec Life Systems, Inc.
22002 26th Ave Se, Bothell, WA, United States
Category
Medical devices › Class I
Classification
Class I
Status
Ongoing
Units affected
25,112 units
Initiated by
Voluntary: Firm initiated

Read the official FDA notice ↗

Product

V*Home, Model Number: PRT-01444-000, Package PN:PRT-01445-000. used for ventilatory support.

Why was it recalled?

Ventilator's Internal Flow transducer cable connector may disconnect from internal board, potentially resulting in system reboot and interruption of ventilation therapy.

What should you do?

FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.

Product codes & lot numbers

All Serial Numbers: UDI: 00855573007822

Distribution

Distribution US nationwide including Puerto Rico.

States: Puerto Rico

What does Class I mean?

Class I is the most serious FDA recall class: there is a reasonable probability that using or being exposed to the product will cause serious adverse health consequences or death.

Source: FDA (medical devices), recall Z-0133-2027. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.