{"recall":{"id":"fda-device-99835","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"Ventec Life Systems, Inc. recalls 12 products","firm":"Ventec Life Systems, Inc.","date":"2026-09-17","reported":"2026-10-28","status":"Ongoing","classification":"Class I","products":[{"name":"VOCSN+Pro, Model Number:PRT-00490-001, Package PN:PRT-00853-000. used for ventilatory support.","code":"All Serial Numbers: UDI: 00855573007792, 00855573007006","quantity":"4,369 units","number":"Z-0122-2027","classification":"Class I"},{"name":"VOCSN+Pro (Japan), Model Number: PRT-00490-100, Package PN:PRT-00853-100. used for ventilatory support.","code":"All Serial Numbers: UDI: 00855573007761, 00855573007204","quantity":"325 units","number":"Z-0123-2027","classification":"Class I"},{"name":"VC+Pro Model Number: PRT-00900-001, Package PN:PRT-00973-000. used for ventilatory support.","code":"All Serial Numbers: UDI: 00855573007785, 00855573007433","quantity":"1,534 units","number":"Z-0124-2027","classification":"Class I"},{"name":"VC+Pro (Japan) Model Number: PRT-00900-100, Package PN:PRT-00973-100. used for ventilatory support.","code":"All Serial Numbers: UDI: 00855573007211","quantity":"606 units","number":"Z-0125-2027","classification":"Class I"},{"name":"VOCSN Model Number: PRT-01100-000, Package PN:PRT-01126-000. used for ventilatory support.","code":"All Serial Numbers: UDI: 00855573007747","quantity":"1,532 units","number":"Z-0126-2027","classification":"Class I"},{"name":"VOCSN (Japan) Model Number: PRT-01100-100, Package PN:PRT-01126-100. used for ventilatory support.","code":"All Serial Numbers: UDI: 00850018761130","quantity":"100 units","number":"Z-0127-2027","classification":"Class I"},{"name":"VCSN+Pro Model Number: PRT-01184-000, Package PN:PRT-01172-000. used for ventilatory support.","code":"All Serial Numbers: UDI: 00855573007860","quantity":"4,368 units","number":"Z-0128-2027","classification":"Class I"},{"name":"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.","code":"All Serial Numbers: PRT-01185-000 -UDI: 00855573007877; PRT-01185-001 - UDI: 00850018761161; PRT-01185-002 - UDI: 00850018761154","quantity":"39,568 units","number":"Z-0129-2027","classification":"Class I"},{"name":"VC Model Number: PRT-01098-000, Package PN:PRT-01125-000. used for ventilatory support.","code":"All Serial Numbers: UDI: 00855573007730","quantity":"930 units","number":"Z-0130-2027","classification":"Class I"},{"name":"VC(Japan) Model Number: PRT-01098-100, Package PN:PRT-01125-100. used for ventilatory support.","code":"All Serial Numbers: UDI: 00850018761116","quantity":"180 units","number":"Z-0131-2027","classification":"Class I"},{"name":"V+ Pro Emergency, Model Number: PRT-01201-000, Package PN:PRT-01173-000,PRT-01222-000. used for ventilatory support.","code":"All Serial Numbers: UDI: 00855573007945","quantity":"30,120 units","number":"Z-0132-2027","classification":"Class I"},{"name":"V*Home, Model Number: PRT-01444-000, Package PN:PRT-01445-000. used for ventilatory support.","code":"All Serial Numbers: UDI: 00855573007822","quantity":"25,112 units","number":"Z-0133-2027","classification":"Class I"}],"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).","affected":"Distribution US nationwide including Puerto Rico.","nationwide":true,"states":[],"units":"4,369 units; 325 units; 1,534 units; 606 units; 1,532 units; 100 units; 4,368 units; 39,568 units; 930 units; 180 units; 30,120 units; 25,112 units","remedy":"","whatToDo":"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.","contact":"","url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99835","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"390024a6ea9fd6dc","firstSeen":"2026-11-02T22:17:07.772Z","updatedAt":"2026-11-02T22:17:07.772Z","history":[]},"official":{"fetchedAt":"2026-11-02T22:17:07.772Z","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","officialUrl":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99835","record":[{"status":"Ongoing","city":"Bothell","state":"WA","country":"United States","classification":"Class I","openfda":{},"product_type":"Devices","event_id":"99835","recalling_firm":"Ventec Life Systems, Inc.","address_1":"22002 26th Ave Se","address_2":"","postal_code":"98021-4903","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"Distribution US nationwide including Puerto Rico.","recall_number":"Z-0122-2027","product_description":"VOCSN+Pro,   Model Number:PRT-00490-001, Package PN:PRT-00853-000. used for ventilatory support.","product_quantity":"4,369 units","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.","recall_initiation_date":"20260917","center_classification_date":"20261020","report_date":"20261028","code_info":"All Serial Numbers: UDI: 00855573007792, 00855573007006","more_code_info":""},{"status":"Ongoing","city":"Bothell","state":"WA","country":"United States","classification":"Class I","openfda":{},"product_type":"Devices","event_id":"99835","recalling_firm":"Ventec Life Systems, Inc.","address_1":"22002 26th Ave Se","address_2":"","postal_code":"98021-4903","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"Distribution US nationwide including Puerto Rico.","recall_number":"Z-0123-2027","product_description":"VOCSN+Pro (Japan),   Model Number: PRT-00490-100, Package PN:PRT-00853-100. used for ventilatory support.","product_quantity":"325 units","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.","recall_initiation_date":"20260917","center_classification_date":"20261020","report_date":"20261028","code_info":"All Serial Numbers: UDI: 00855573007761, 00855573007204","more_code_info":""},{"status":"Ongoing","city":"Bothell","state":"WA","country":"United States","classification":"Class I","openfda":{},"product_type":"Devices","event_id":"99835","recalling_firm":"Ventec Life Systems, Inc.","address_1":"22002 26th Ave Se","address_2":"","postal_code":"98021-4903","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"Distribution US nationwide including Puerto Rico.","recall_number":"Z-0124-2027","product_description":"VC+Pro   Model Number: PRT-00900-001, Package PN:PRT-00973-000. used for ventilatory support.","product_quantity":"1,534 units","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.","recall_initiation_date":"20260917","center_classification_date":"20261020","report_date":"20261028","code_info":"All Serial Numbers: UDI: 00855573007785, 00855573007433","more_code_info":""},{"status":"Ongoing","city":"Bothell","state":"WA","country":"United States","classification":"Class I","openfda":{},"product_type":"Devices","event_id":"99835","recalling_firm":"Ventec Life Systems, Inc.","address_1":"22002 26th Ave Se","address_2":"","postal_code":"98021-4903","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"Distribution US nationwide including Puerto Rico.","recall_number":"Z-0125-2027","product_description":"VC+Pro (Japan)   Model Number: PRT-00900-100, Package PN:PRT-00973-100. used for ventilatory support.","product_quantity":"606 units","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.","recall_initiation_date":"20260917","center_classification_date":"20261020","report_date":"20261028","code_info":"All Serial Numbers: UDI: 00855573007211","more_code_info":""},{"status":"Ongoing","city":"Bothell","state":"WA","country":"United States","classification":"Class I","openfda":{},"product_type":"Devices","event_id":"99835","recalling_firm":"Ventec Life Systems, Inc.","address_1":"22002 26th Ave Se","address_2":"","postal_code":"98021-4903","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"Distribution US nationwide including Puerto Rico.","recall_number":"Z-0126-2027","product_description":"VOCSN   Model Number: PRT-01100-000, Package PN:PRT-01126-000. used for ventilatory support.","product_quantity":"1,532 units","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.","recall_initiation_date":"20260917","center_classification_date":"20261020","report_date":"20261028","code_info":"All Serial Numbers: UDI: 00855573007747","more_code_info":""},{"status":"Ongoing","city":"Bothell","state":"WA","country":"United States","classification":"Class I","openfda":{},"product_type":"Devices","event_id":"99835","recalling_firm":"Ventec Life Systems, Inc.","address_1":"22002 26th Ave Se","address_2":"","postal_code":"98021-4903","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"Distribution US nationwide including Puerto Rico.","recall_number":"Z-0127-2027","product_description":"VOCSN (Japan)   Model Number: PRT-01100-100, Package PN:PRT-01126-100. used for ventilatory support.","product_quantity":"100 units","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.","recall_initiation_date":"20260917","center_classification_date":"20261020","report_date":"20261028","code_info":"All Serial Numbers: UDI: 00850018761130","more_code_info":""},{"status":"Ongoing","city":"Bothell","state":"WA","country":"United States","classification":"Class I","openfda":{},"product_type":"Devices","event_id":"99835","recalling_firm":"Ventec Life Systems, Inc.","address_1":"22002 26th Ave Se","address_2":"","postal_code":"98021-4903","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"Distribution US nationwide including Puerto Rico.","recall_number":"Z-0128-2027","product_description":"VCSN+Pro   Model Number: PRT-01184-000, Package PN:PRT-01172-000. used for ventilatory support.","product_quantity":"4,368 units","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.","recall_initiation_date":"20260917","center_classification_date":"20261020","report_date":"20261028","code_info":"All Serial Numbers: UDI: 00855573007860","more_code_info":""},{"status":"Ongoing","city":"Bothell","state":"WA","country":"United States","classification":"Class I","openfda":{},"product_type":"Devices","event_id":"99835","recalling_firm":"Ventec Life Systems, Inc.","address_1":"22002 26th Ave Se","address_2":"","postal_code":"98021-4903","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"Distribution US nationwide including Puerto Rico.","recall_number":"Z-0129-2027","product_description":"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.","product_quantity":"39,568 units","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.","recall_initiation_date":"20260917","center_classification_date":"20261020","report_date":"20261028","code_info":"All Serial Numbers: PRT-01185-000 -UDI: 00855573007877;  PRT-01185-001 - UDI: 00850018761161; PRT-01185-002 - UDI: 00850018761154","more_code_info":""},{"status":"Ongoing","city":"Bothell","state":"WA","country":"United States","classification":"Class I","openfda":{},"product_type":"Devices","event_id":"99835","recalling_firm":"Ventec Life Systems, Inc.","address_1":"22002 26th Ave Se","address_2":"","postal_code":"98021-4903","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"Distribution US nationwide including Puerto Rico.","recall_number":"Z-0130-2027","product_description":"VC   Model Number: PRT-01098-000, Package PN:PRT-01125-000. used for ventilatory support.","product_quantity":"930 units","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.","recall_initiation_date":"20260917","center_classification_date":"20261020","report_date":"20261028","code_info":"All Serial Numbers: UDI: 00855573007730","more_code_info":""},{"status":"Ongoing","city":"Bothell","state":"WA","country":"United States","classification":"Class I","openfda":{},"product_type":"Devices","event_id":"99835","recalling_firm":"Ventec Life Systems, Inc.","address_1":"22002 26th Ave Se","address_2":"","postal_code":"98021-4903","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"Distribution US nationwide including Puerto Rico.","recall_number":"Z-0131-2027","product_description":"VC(Japan)   Model Number: PRT-01098-100, Package PN:PRT-01125-100. used for ventilatory support.","product_quantity":"180 units","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.","recall_initiation_date":"20260917","center_classification_date":"20261020","report_date":"20261028","code_info":"All Serial Numbers: UDI: 00850018761116","more_code_info":""},{"status":"Ongoing","city":"Bothell","state":"WA","country":"United States","classification":"Class I","openfda":{},"product_type":"Devices","event_id":"99835","recalling_firm":"Ventec Life Systems, Inc.","address_1":"22002 26th Ave Se","address_2":"","postal_code":"98021-4903","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"Distribution US nationwide including Puerto Rico.","recall_number":"Z-0132-2027","product_description":"V+ Pro Emergency, Model Number: PRT-01201-000, Package PN:PRT-01173-000,PRT-01222-000. used for ventilatory support.","product_quantity":"30,120 units","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.","recall_initiation_date":"20260917","center_classification_date":"20261020","report_date":"20261028","code_info":"All Serial Numbers: UDI: 00855573007945","more_code_info":""},{"status":"Ongoing","city":"Bothell","state":"WA","country":"United States","classification":"Class I","openfda":{},"product_type":"Devices","event_id":"99835","recalling_firm":"Ventec Life Systems, Inc.","address_1":"22002 26th Ave Se","address_2":"","postal_code":"98021-4903","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"Distribution US nationwide including Puerto Rico.","recall_number":"Z-0133-2027","product_description":"V*Home, Model Number: PRT-01444-000, Package PN:PRT-01445-000. used for ventilatory support.","product_quantity":"25,112 units","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.","recall_initiation_date":"20260917","center_classification_date":"20261020","report_date":"20261028","code_info":"All Serial Numbers: UDI: 00855573007822","more_code_info":""}]}}