Ventec Life Systems, Inc. recalls VOCSN+Pro package
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.
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
VOCSN+Pro package1 code
- PRT-00853-000
VOCSN+Pro unit1 code
- PRT-00490-001
Lot / code information
- Lot #
- PRT-00853-000/00855573007839/155391P/807138, PRT-00490-001/00855573007792/155391/804613
What the firm 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 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.
DistributionShow detailsHide
US Nationwide distribution in the state of UT.
Use of the product may cause temporary or medically reversible adverse health consequences.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-2525-2026
- FDA 510(k) clearance · K162877The device's official FDA premarket clearance record
- FDA device classification · CBKOfficial FDA classification for this device type
- CFR regulation · 21 CFR 868.5895The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find Ventec Life Systems, Inc.Search for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
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