Ventec Life Systems, Inc. medical device recall: VOCSN+Pro
Key facts
- Agency
- U.S. Food and Drug Administration (FDA)
- Program
- Medical devices
- Classification
- Class I
- Status
- Ongoing
- Event ID
- 99835
- Recall initiated
- Sep 17, 2026
- Classified by FDA
- Oct 20, 2026
- Posted in Enforcement Report
- Oct 28, 2026
- Recalling firm
- Ventec Life Systems, Inc.
- Firm location
- Bothell, WA, United States
- Initiated by
- Voluntary: Firm initiated
- Firm notified customers by
- Letter
- Products in this event
- 12
What to do
Compare the product, lot or serial numbers below with what you have. If you use a prescription drug or medical device in this recall, talk to your pharmacist or health care provider before you stop using it, and follow the firm's instructions.
Reason for recall
Ventilator's Internal Flow transducer cable connector may disconnect from internal board, potentially resulting in system reboot and interruption of ventilation therapy.
What the classification means
- Class I: FDA's most serious category: there is a reasonable probability that using or being exposed to the product will cause serious health problems or death.
About this recall
The firm started this recall on Sep 17, 2026. FDA classified it 33 days later, on Oct 20, 2026. This recall event covers 12 separate products, each with its own FDA recall number. Distribution reported by FDA: Distribution US nationwide including Puerto Rico. Ventec Life Systems, Inc. has 7 recalls in our records.
Recalled products (12)
Z-0122-2027 Class I Ongoing
VOCSN+Pro, Model Number:PRT-00490-001, Package PN:PRT-00853-000. used for ventilatory support.
Codes / lots: All Serial Numbers: UDI: 00855573007792, 00855573007006
Quantity: 4,369 units
Z-0123-2027 Class I Ongoing
VOCSN+Pro (Japan), Model Number: PRT-00490-100, Package PN:PRT-00853-100. used for ventilatory support.
Codes / lots: All Serial Numbers: UDI: 00855573007761, 00855573007204
Quantity: 325 units
Z-0124-2027 Class I Ongoing
VC+Pro Model Number: PRT-00900-001, Package PN:PRT-00973-000. used for ventilatory support.
Codes / lots: All Serial Numbers: UDI: 00855573007785, 00855573007433
Quantity: 1,534 units
Z-0125-2027 Class I Ongoing
VC+Pro (Japan) Model Number: PRT-00900-100, Package PN:PRT-00973-100. used for ventilatory support.
Codes / lots: All Serial Numbers: UDI: 00855573007211
Quantity: 606 units
Z-0126-2027 Class I Ongoing
VOCSN Model Number: PRT-01100-000, Package PN:PRT-01126-000. used for ventilatory support.
Codes / lots: All Serial Numbers: UDI: 00855573007747
Quantity: 1,532 units
Z-0127-2027 Class I Ongoing
VOCSN (Japan) Model Number: PRT-01100-100, Package PN:PRT-01126-100. used for ventilatory support.
Codes / lots: All Serial Numbers: UDI: 00850018761130
Quantity: 100 units
Z-0128-2027 Class I Ongoing
VCSN+Pro Model Number: PRT-01184-000, Package PN:PRT-01172-000. used for ventilatory support.
Codes / lots: All Serial Numbers: UDI: 00855573007860
Quantity: 4,368 units
Z-0129-2027 Class I Ongoing
V+Pro Model Number: PRT-01185-000, Package PN:PRT-01198-000; Model Number: PRT-01185-001, Package PN: N/A; Model Number: PRT-01185-002, Package PN:N/A. used for ventilatory support.
Codes / lots: All Serial Numbers: PRT-01185-000 -UDI: 00855573007877; PRT-01185-001 - UDI: 00850018761161; PRT-01185-002 - UDI: 00850018761154
Quantity: 39,568 units
Z-0130-2027 Class I Ongoing
VC Model Number: PRT-01098-000, Package PN:PRT-01125-000. used for ventilatory support.
Codes / lots: All Serial Numbers: UDI: 00855573007730
Quantity: 930 units
Z-0131-2027 Class I Ongoing
VC(Japan) Model Number: PRT-01098-100, Package PN:PRT-01125-100. used for ventilatory support.
Codes / lots: All Serial Numbers: UDI: 00850018761116
Quantity: 180 units
Z-0132-2027 Class I Ongoing
V+ Pro Emergency, Model Number: PRT-01201-000, Package PN:PRT-01173-000,PRT-01222-000. used for ventilatory support.
Codes / lots: All Serial Numbers: UDI: 00855573007945
Quantity: 30,120 units
Z-0133-2027 Class I Ongoing
V*Home, Model Number: PRT-01444-000, Package PN:PRT-01445-000. used for ventilatory support.
Codes / lots: All Serial Numbers: UDI: 00855573007822
Quantity: 25,112 units
Source and freshness
- Source
- U.S. Food and Drug Administration (FDA) Enforcement Report, via the openFDA device enforcement dataset
- Official notice
- FDA Enforcement Report, event 99835
- Raw record
- openFDA API (JSON)
- Dataset last updated by FDA
- Nov 3, 2026
- Imported by RecallRadar
- Nov 4, 2026
Enforcement Report entries describe recalls FDA has classified. They are not always the same as a company press release. If something here differs from FDA's record, FDA's record is correct — please tell us.