VOCSN+Pro package, REF: PRT-00853-000; VOCSN+Pro unit, REF: PRT-00490-001
FDA Recall Z-2525-2026 · Posted 2026-06-23
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Recalling FirmVentec Life Systems, Inc.
Recall StatusOpen, Classified
Product CodeCBK
Date Initiated2026-05-08
Product Quantity1
Reason for Recall
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.
Firm Action
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.
Root Cause
Vendor change control
Distribution Pattern
US Nationwide distribution in the state of UT.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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