Skip to content

VOCSN recallZ-1942-2026 · Ventec Life Systems, Inc. · initiated Mar 25, 2026

Open, Classified

Is my device affected?

  1. 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.
  2. 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.
  3. 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 not have been evaluated under all intended high-pressure conditions during production testing, so an oxygen leak condition could occur that may lead to reduced below intended levels of fraction of inspired oxygen delivery prior to and during ventilation and this oxygen-enriched environment may increase fire risk

FDA root cause category: Process change control

What the company is doing

On 3/25/2026 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 a non-affected 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. Complete and return the response form via email to [email protected] 6. If you are no longer the owner of any of these devices, you need to complete an ownership transfer form at: VentecLife.com/tracking so firm can follow up with the current owner of the impacted device(s). If you have questions, you can contact the firm at 844-698-6276

Recall details

Recall number
Z-1942-2026
Status
Open, Classified
Initiated by the company
Mar 25, 2026
Posted by the FDA
May 1, 2026
Recalling firm
Ventec Life Systems, Inc.
Quantity
42
Product code
NOU
FDA submissions
K162877
Distribution
US: OH, GA, CA, MO

Product description

VOCSN V+Pro package, REF: PRT-01198-000; VOCSN V+Pro unit, REF: PRT-01185-000

Code information (models, lots, serial numbers)

UDI-DI (REF/UDI-DI): PRT-01198-000/00855573007914, PRT-01185-000/00855573007877 Package/Device Serial Number (package serial number may include a "P" at the end): 152884, 152885, 152886, 152887, 152888, 152889, 152890, 152891, 152892, 152893, 152895, 152896, 152897, 152898, 152899, 152900, 152901, 152902, 152903, 152904, 152908, 152909, 152910, 152911, 152912, 152913, 152914, 152915, 152916, 152917, 152918, 152919, 152986, 152987, 155236, 156507, 156512, 156515, 156516, 156517, 156524, 156532

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

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.

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page