FDA Medical Device Recalls (openFDA)
Ventec Life Systems, Inc.: VOCSN+Pro package, REF: PRT-00853-000; VOCSN+Pro unit, REF: PRT-00490-001
- Recall number
- Z-2525-2026
- Recalling firm
- Ventec Life Systems, Inc.
- Product
- VOCSN+Pro package, REF: PRT-00853-000; VOCSN+Pro unit, REF: PRT-00490-001
- Status
- Open, Classified
- Initiated
- 2026-05-08
- Posted
- 2026-06-23
- Terminated
- not on file
- Reason
- 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.
- Root cause
- Vendor change control
- 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 Ventec-Recall@reacthealth.com 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.
- Quantity
- 1
- Distribution
- US Nationwide distribution in the state of UT.
- Lot, serial or model codes
- REF/UDI-DI/Serial Number/Lot: PRT-00853-000/00855573007839/155391P/807138, PRT-00490-001/00855573007792/155391/804613
- 510(k) numbers
- ["K162877"]
- PMA numbers
- not on file
- Product code
- CBK
- Firm FEI
- 3013095415
- Firm city
- Bothell
- Firm state
- WA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28