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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Critical RiskFDA Device
Medical Devices/Monitoring Devices

VOCSN Multi-Function Ventilators Recalled Due to Servicing Errors

Agency Publication Date: February 26, 2025
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Summary

Ventec Life Systems, Inc. is recalling 30 VOCSN Multi-Function Ventilators, including VOCSN+Pro and V+Pro models. These ventilators were serviced using incorrect parts, which may cause the devices to fail or provide inaccurate breathing support. There have been no reported injuries related to this issue, but the manufacturer is voluntarily taking action to correct the units.

Risk

The use of incorrect parts during servicing could cause the ventilator to shut down unexpectedly or deliver incorrect levels of air pressure and volume to the patient. This defect may prevent the device from properly responding to a patient's breathing efforts, posing a critical risk to those who depend on it for life support.

What You Should Do

  1. This recall affects 30 VOCSN Multi-Function Ventilators, including models VOCSN+Pro (REF PRT-00490-001) and V+Pro (REF PRT-01185-000 and PRT-01185-002).
  2. Check the serial number on your device label to determine if your ventilator is part of the recall. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.
  4. Contact Ventec Life Systems, Inc. directly for further instructions regarding this service correction.
  5. Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) for additional questions regarding this recall.

Your Remedy Options

๐Ÿ“‹Other Action

Correction for devices serviced with incorrect parts.

How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: VOCSN Multi-Function Ventilator: VOCSN+Pro (V+O+C+S+N+Pro, English)
Variants: English language version
Model / REF:
PRT-00490-001
Serial Numbers:
123627
121892
119639
UDI:
00855573007792

Units serviced with incorrect parts.

Product: VOCSN Multi-Function Ventilator: V+Pro (V+Pro, English)
Variants: English language version
Model / REF:
PRT-01185-000
PRT-01185-002
Serial Numbers:
5038421
116700
117933
5038112
5038619
5038717
5038953
5039086
5039091
5039361
5039499
5039503
5039541
5039636
5039938
5040019
5040640
5040762
5041060
5041078
5041534
5042558
117344
118464
118509
5039387
5037655
UDI:
00855573007877
00850018761154

Units serviced with incorrect parts.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96136
Status: Active
Manufacturer: Ventec Life Systems, Inc.
Sold By: authorized medical device distributors
Manufactured In: United States
Units Affected: 30
Distributed To: California, New York, Missouri

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.