Z-2525-2026Class II

VOCSN+Pro package, REF: PRT-00853-000; VOCSN+Pro unit, REF: PRT-00490-001

Name: Z-2525-2026 VOCSN+Pro package, REF: PRT-00853-000; VOCSN+Pro unit, REF: PRT-00490-001
Creator: Ventec Life Systems, Inc.
Published: 2026-05-08
License: https://open.fda.gov/license/

Ventec Life Systems, Inc. / initiated 2026-05-08 / Open, Classified / root cause: supplier

FDA source

Ventec Life Systems, Inc. began a recall of VOCSN+Pro package, REF: PRT-00853-000; VOCSN+Pro unit, REF: PRT-00490-001 on 2026-05-08. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as supplier.

Recall record

Recall number: Z-2525-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-05-08
Posted: 2026-06-23
Recalling firm: Ventec Life Systems, Inc.
Product: VOCSN+Pro package, REF: PRT-00853-000; VOCSN+Pro unit, REF: PRT-00490-001
Product code: CBK Ventilator, Continuous, Facility Use
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.
Root cause tag: supplier
FDA 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 [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.
Quantity in commerce: 1
Distribution: US Nationwide distribution in the state of UT.
Product codes and lots: REF/UDI-DI/Serial Number/Lot: PRT-00853-000/00855573007839/155391P/807138, PRT-00490-001/00855573007792/155391/804613

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2525-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2525-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-01	2026-06-23

Product code CBK

K162877Class IIVOCSN Unified Respiratory SystemVentec Life Systems, Inc. / cleared 2017-04-07

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)