On September 17, 2026, Ventec Life Systems, Inc. initiated a Class I recall of several ventilatory support devices due to a potential safety issue. The recall affects devices including the VOCSN and V+ Pro Emergency models, which may experience a disconnection of the internal flow transducer cable connector, potentially interrupting ventilation therapy.
The recall is ongoing and includes distribution across the U.S. nationwide, including Puerto Rico. Details can be found in the FDA's weekly enforcement report, specifically FDA recall event 99835.
Press Release: Food and Drug Administration
Published October 28, 2026. Reproduced in full from the Food and Drug Administration.
Ventec Life Systems, Inc. medical device recall
- Recalling company: Ventec Life Systems, Inc.
- Classification: Class I (the most serious type)
- Recall numbers: Z-0122-2027, Z-0123-2027, Z-0124-2027, Z-0125-2027, Z-0126-2027, Z-0127-2027, Z-0128-2027, Z-0129-2027, Z-0130-2027, Z-0131-2027, Z-0132-2027, Z-0133-2027
- Status: Ongoing
- Distribution: Distribution US nationwide including Puerto Rico.
- Recall started: September 17, 2026
What was recalled
VOCSN (Japan) Model Number: PRT-01100-100, Package PN:PRT-01126-100. used for ventilatory support.
V+ Pro Emergency, Model Number: PRT-01201-000, Package PN:PRT-01173-000,PRT-01222-000. used for ventilatory support.
VC(Japan) Model Number: PRT-01098-100, Package PN:PRT-01125-100. used for ventilatory support.
VCSN+Pro Model Number: PRT-01184-000, Package PN:PRT-01172-000. used for ventilatory support.
VOCSN Model Number: PRT-01100-000, Package PN:PRT-01126-000. used for ventilatory support.
VOCSN+Pro (Japan), Model Number: PRT-00490-100, Package PN:PRT-00853-100. 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.
This medical device recall appears in the FDA's weekly enforcement report. Details: FDA recall event 99835.
