VOCSN recallZ-2525-2026 · Ventec Life Systems, Inc. · initiated May 8, 2026
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Ventec Life Systems, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Respiratory system intended to provide continuous/intermittent ventilator support, may have a damaged back-up battery supporting backup alarm function, which may result in the backup alarm not activating during loss of primary power and absence/depletion of backup power sources, which may result in delayed caregiver awareness of a hazardous condition.
FDA root cause category: Vendor change control
What the company is doing
On 5/8/2026, recall notices were mailed to customers who were asked to do the following: 1) Immediately discontinue use of affected devices. 2) Inspect current stock, quarantine/segregate any unused affected products, remove affected devices from clinical service and segregate to prevent further use. 3) Use an unaffected ventilator for patient support. 4) If you have distributed or transferred affected devices to other facilities, caregivers, or end users, you must promptly notify them of this recall and provide a copy of this notification. 5) Confirm receipt of this notification letter by returning the enclosed Customer Response Form via email to [email protected] Upon receipt of the Customer Response Form, firm will arrange for repair of existing device(s). Return the affected product to React Health If you have any questions, please contact firm at 844-698-6276.
Recall details
- Recall number
- Z-2525-2026
- Status
- Open, Classified
- Initiated by the company
- May 8, 2026
- Posted by the FDA
- Jun 23, 2026
- Recalling firm
- Ventec Life Systems, Inc.
- Quantity
- 1
- Product code
- CBK
- FDA submissions
- K162877
- Distribution
- US Nationwide distribution in the state of UT.
Product description
VOCSN+Pro package, REF: PRT-00853-000; VOCSN+Pro unit, REF: PRT-00490-001
Code information (models, lots, serial numbers)
REF/UDI-DI/Serial Number/Lot: PRT-00853-000/00855573007839/155391P/807138, PRT-00490-001/00855573007792/155391/804613
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- VOCSN V+O+C+S+N+Pro, EnglishVentec Life Systems, Inc. · Filter, Bacterial, Breathing-Circuit3 recalls366 reports
Product lines
Other devices under the same FDA submission
22 devices cleared under K162877 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- VOCSN V+Pro, EnglishVentec Life Systems, Inc. · Filter, Bacterial, Breathing-Circuit1 recall570 reports
- VOCSN V+Pro Emergency, EnglishVentec Life Systems, Inc. · Filter, Bacterial, Breathing-Circuit558 reports
- VOCSN V+Pro, EnglishVentec Life Systems, Inc. · Filter, Bacterial, Breathing-Circuit2 recalls2 deaths325 reports
- VOCSN V+O+C+S+N, EnglishVentec Life Systems, Inc. · Ventilator, Continuous, Facility Use1 recall286 reports
- VOCSN V*Home, EnglishVentec Life Systems, Inc. · Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer4 deaths318 reports
- VOCSN V+C+S+N+Pro, EnglishVentec Life Systems, Inc. · Filter, Bacterial, Breathing-Circuit185 reports
- VOCSN VOCSN, EnglishVentec Life Systems, Inc. · Filter, Bacterial, Breathing-Circuit1 death96 reports
- VOCSN V+C+Pro, JapaneseVentec Life Systems, Inc. · Filter, Bacterial, Breathing-Circuit1 recall33 reports
- VOCSN V+O+C+S+N+Pro, JapaneseVentec Life Systems, Inc. · Filter, Bacterial, Breathing-Circuit1 recall32 reports
- VOCSN V+C, EnglishVentec Life Systems, Inc. · Ventilator, Continuous, Facility Use1 recall27 reports
- VOCSN Patient Breathing Package Pediatric, Active, Oxygen, BlueVentec Life Systems, Inc. · Device, Positive Pressure Breathing, Intermittent1 recall25 reports
- VOCSN V+C+Pro, EnglishVentec Life Systems, Inc. · Filter, Bacterial, Breathing-Circuit1 recall25 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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