Class I recallOngoing

VOCSN Multi-Function Ventilators: VOCSN+Pro (V+O+C+S+N+Pro, English) recall — FDA event 96136

FDA · FDA event 96136 · Posted Feb 26, 2025

Published Feb 26, 2025Updated Oct 8, 2026Source last checked: 2026-10-08 16:03:16 UTC

Update delayed: We have not successfully checked this official source since 2026-10-08 18:58:41 UTC. This page may not include the latest recall or safety information. Check the linked FDA source before making a health decision.

What happened

Multi-Function Ventilators were serviced using incorrect parts which have the potential to cause unexpected shutdown, or when using an active circuit could result in inaccurate tidal volume monitor, not triggering on patient efforts, less inspiratory volume, less inspiratory pressure, and less PEEP delivered.

Who may be affected

People using a product, model, software version, lot, or UDI listed in the affected-products table and official FDA record.
A mention of the device family does not mean every unit is affected. Compare the identifiers on your product with the official source.

What the official notice recommends

On 02/03/2025, recall notices were sent to Durable Medical Equipment Distributors asking them to do the following:
Clinical Action: Follow internal procedures to transfer the patient to an alternative source of ventilation, if available. If no other ventilation method is available, you may continue to use the affected product adhering to the guidelines below, while you await device correction by firm Service personnel: 1. Use only when the patient is actively monitored to ensure timely response to a potential malfunction. 2. Operate the ventilator as defined in the Instructions for Use and promptly respond to all alarms activated by the ventilator. 3. Use external monitors (e.g. SpO2) and set the alarm thresholds appropriately for the patient. 4. Connect the ventilator to an external monitoring system, wherever possible.
Also, Durable Medical Equipment Distributors are asked to acknowledge they forwarded the recall notice, and that they contacted the users to which the devices were provided, advised them of the recall and action instructions within accompanying Recall Notification Letter including how to have the devices repaired.
Complete and return the acknowledgement form via email to Ventec-Recall@reacthealth.com
For any questions contact the firm at at 844-MYVOCSN (844-698-6276), Monday through Friday between 8:00 a.m. - 5:00 p.m. PDT.

The official notice takes precedence over this summary. Talk to your clinician before changing prescribed therapy.

Affected products and models

This FDA record lists VOCSN Multi-Function Ventilators: VOCSN+Pro (V+O+C+S+N+Pro, English) by Ventec Life Systems, Inc..

Products affected by FDA event 96136
Model	Description	Lot / serial range	Manufactured	Status
Z-1196-2025	Z-1196-2025	REF/UDI-DI/Serial Numbers: PRT-00490-001/00855573007792/123627, 121892, 119639; PRT-01185-000/00855573007877/5038421, 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; PRT-01185-002/00850018761154/5037655	Not provided in the normalized record	Ongoing

Distribution: US distribution in CA, NY, and MO.
Units affected: See official FDA record
Category: Ventilators

Timeline

Feb 3, 2025
Recall initiated
Date recorded by the FDA.
Feb 26, 2025
Posted by FDA
The recall event appeared in the FDA source.
Oct 8, 2026
Last checked
MedWatcher last reconciled this record with the openFDA export.

Primary source

U.S. Food and Drug Administration

Identifier: 96136
Published: Feb 26, 2025
Source checked: 2026-10-08 16:03:16 UTC

Official openFDA device-recall record. The FDA source takes precedence over this normalized summary.

View official record

How MedWatcher checks these sources

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VOCSN Multi-Function Ventilators: VOCSN+Pro (V+O+C+S+N+Pro, English) recall — FDA event 96136

FDA · FDA event 96136 · Posted Feb 26, 2025

Published Feb 26, 2025Updated Oct 8, 2026Source last checked: 2026-10-08 16:03:16 UTC

What happened

Affected products and models

This FDA record lists VOCSN Multi-Function Ventilators: VOCSN+Pro (V+O+C+S+N+Pro, English) by Ventec Life Systems, Inc..

Products affected by FDA event 96136
Model	Description	Lot / serial range	Manufactured	Status
Z-1196-2025	Z-1196-2025	REF/UDI-DI/Serial Numbers: PRT-00490-001/00855573007792/123627, 121892, 119639; PRT-01185-000/00855573007877/5038421, 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; PRT-01185-002/00850018761154/5037655	Not provided in the normalized record	Ongoing

Distribution

US distribution in CA, NY, and MO.

Units affected

See official FDA record

Resmed Astral 100/150 Resmed Astral 100/50 recall — FDA event 99304

Due to a Supercapacitor electrolyte leakage on Printed Circuit Board Assembly (PCBA) may damage the charger chip, causing fail-safe state and interruption of ventilation therapy.

FDA · FDA event 99304Posted Jul 28, 2026

Class II recallOngoing

VOCSN+Pro package recall — FDA event 98888

FDA · FDA event 98888Posted Jun 23, 2026

Class I recallOngoing

VOCSN V+Pro package recall — FDA event 98554

FDA · FDA event 98554Posted May 1, 2026

VOCSN Multi-Function Ventilators: VOCSN+Pro (V+O+C+S+N+Pro, English) recall — FDA event 96136

Follow VOCSN Multi-Function Ventilators: VOCSN+Pro (V+O+C+S+N+Pro, English)

What happened

Who may be affected

What the official notice recommends

Affected products and models

Timeline

VOCSN Multi-Function Ventilators: VOCSN+Pro (V+O+C+S+N+Pro, English) recall — FDA event 96136

Follow VOCSN Multi-Function Ventilators: VOCSN+Pro (V+O+C+S+N+Pro, English)

What happened

Who may be affected

What the official notice recommends

Affected products and models

Timeline

What happened

Who may be affected

What to do

What the official notice recommends

Affected products and models

Timeline

What happened

Who may be affected

What to do

What the official notice recommends

Affected products and models

Timeline