FDA Medical devices recall ·
VOCSN+Pro (Japan), Model Number: PRT-00490-100, Package PN:PRT-00853-100… recall
This is an FDA Class I recall — the most serious type.
- Recall number
- Z-0123-2027
- 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
- 325 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
VOCSN+Pro (Japan), Model Number: PRT-00490-100, Package PN:PRT-00853-100. 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: 00855573007761, 00855573007204
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-0123-2027. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.