Class IOngoing
Ventec Life Systems, Inc. recalls 12 products
Recall date · record updated Oct 28, 2026 · Source: U.S. Food and Drug Administration (openFDA device enforcement)
Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.
- Company
- Ventec Life Systems, Inc.
- Reason
- Ventilator's Internal Flow transducer cable connector may disconnect from internal board, potentially resulting in system reboot and interruption of ventilation therapy.
- Hazard
- FDA Class I: a reasonable probability that use or exposure will cause serious adverse health consequences or death (FDA definition).
- Who’s affected
- Distribution US nationwide including Puerto Rico.
- Where
- Nationwide
- Official notice
- www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99835…
Products (12)
VOCSN+Pro, Model Number:PRT-00490-001, Package PN:PRT-00853-000. used for ventilatory support.
Codes/lots: All Serial Numbers: UDI: 00855573007792, 00855573007006Quantity: 4,369 unitsRecall no. Z-0122-2027Class IVOCSN+Pro (Japan), Model Number: PRT-00490-100, Package PN:PRT-00853-100. used for ventilatory support.
Codes/lots: All Serial Numbers: UDI: 00855573007761, 00855573007204Quantity: 325 unitsRecall no. Z-0123-2027Class IVC+Pro Model Number: PRT-00900-001, Package PN:PRT-00973-000. used for ventilatory support.
Codes/lots: All Serial Numbers: UDI: 00855573007785, 00855573007433Quantity: 1,534 unitsRecall no. Z-0124-2027Class IVC+Pro (Japan) Model Number: PRT-00900-100, Package PN:PRT-00973-100. used for ventilatory support.
Codes/lots: All Serial Numbers: UDI: 00855573007211Quantity: 606 unitsRecall no. Z-0125-2027Class IVOCSN Model Number: PRT-01100-000, Package PN:PRT-01126-000. used for ventilatory support.
Codes/lots: All Serial Numbers: UDI: 00855573007747Quantity: 1,532 unitsRecall no. Z-0126-2027Class IVOCSN (Japan) Model Number: PRT-01100-100, Package PN:PRT-01126-100. used for ventilatory support.
Codes/lots: All Serial Numbers: UDI: 00850018761130Quantity: 100 unitsRecall no. Z-0127-2027Class IVCSN+Pro Model Number: PRT-01184-000, Package PN:PRT-01172-000. used for ventilatory support.
Codes/lots: All Serial Numbers: UDI: 00855573007860Quantity: 4,368 unitsRecall no. Z-0128-2027Class IV+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: 00850018761154Quantity: 39,568 unitsRecall no. Z-0129-2027Class IVC Model Number: PRT-01098-000, Package PN:PRT-01125-000. used for ventilatory support.
Codes/lots: All Serial Numbers: UDI: 00855573007730Quantity: 930 unitsRecall no. Z-0130-2027Class IVC(Japan) Model Number: PRT-01098-100, Package PN:PRT-01125-100. used for ventilatory support.
Codes/lots: All Serial Numbers: UDI: 00850018761116Quantity: 180 unitsRecall no. Z-0131-2027Class IV+ 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: 00855573007945Quantity: 30,120 unitsRecall no. Z-0132-2027Class IV*Home, Model Number: PRT-01444-000, Package PN:PRT-01445-000. used for ventilatory support.
Codes/lots: All Serial Numbers: UDI: 00855573007822Quantity: 25,112 unitsRecall no. Z-0133-2027Class I
Update history
- First listed on OVERLOOKED from the official record.
When the agency expands or changes this recall, we update this page and log the change here.
Proof: raw official record (JSON) · fetched from FDA API
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