VOCSN+Pro recall (Ventec Life Systems, Inc.)
Medical deviceClass IOngoing
Summary: Ventec Life Systems, Inc. is recalling VOCSN+Pro, Model Number:PRT-00490-001, Package PN:PRT-00853-000. used for ventilatory support.. Reason: Ventilator's Internal Flow transducer cable connector may disconnect from internal board, potentially resulting in system reboot and interruption of ventilation therapy.
What is being recalled
VOCSN+Pro, Model Number:PRT-00490-001, Package PN:PRT-00853-000. used for ventilatory support.
Why
Ventilator's Internal Flow transducer cable connector may disconnect from internal board, potentially resulting in system reboot and interruption of ventilation therapy.
How serious is it
Class I is the most serious level: FDA considers there is a reasonable probability that using or being exposed to this product will cause serious health problems or death.
Where it was sold
Distribution US nationwide including Puerto Rico. (states named: Puerto Rico)
How to tell if yours is affected
All Serial Numbers: UDI: 00855573007792, 00855573007006
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-0122-2027 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class I |
| Status | Ongoing |
| Recall started | September 17, 2026 |
| Reported | October 28, 2026 |
| Company | Ventec Life Systems, Inc. |
| Company location | Bothell, WA, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 4,369 units |
More recalls from Ventec Life Systems, Inc. · all medical device recalls · recalls from September 2026