Class I recallOngoing

VOCSN V+Pro package recall — FDA event 98554

FDA · FDA event 98554 · Posted May 1, 2026

Published May 1, 2026Updated Oct 8, 2026Source last checked: 2026-10-08 16:03:16 UTC

What happened

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

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 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 Ventec-Recall@reacthealth.com 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

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 V+Pro package by Ventec Life Systems, Inc..

Products affected by FDA event 98554
Model	Description	Lot / serial range	Manufactured	Status
Z-1942-2026	Z-1942-2026	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	Not provided in the normalized record	Ongoing

Distribution: US: OH, GA, CA, MO
Units affected: See official FDA record
Category: Ventilators

Timeline

Mar 25, 2026
Recall initiated
Date recorded by the FDA.
May 1, 2026
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: 98554
Published: May 1, 2026
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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FDA · FDA event 99304Posted Jul 28, 2026

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VOCSN+Pro package recall — FDA event 98888

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…

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VOCSN V+Pro package recall — FDA event 98554

FDA · FDA event 98554 · Posted May 1, 2026

Published May 1, 2026Updated Oct 8, 2026Source last checked: 2026-10-08 16:03:16 UTC

What happened

Affected products and models

This FDA record lists VOCSN V+Pro package by Ventec Life Systems, Inc..

Products affected by FDA event 98554
Model	Description	Lot / serial range	Manufactured	Status
Z-1942-2026	Z-1942-2026	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	Not provided in the normalized record	Ongoing

Distribution

US: OH, GA, CA, 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

Philips Respironics Trilogy Evo recall — FDA event 98540

In some situations, the Obstruction Alarm does not trigger within the timeframe dictated by the relevant standards and may take up to four breaths.

FDA · FDA event 98540Posted Apr 2, 2026

VOCSN V+Pro package recall — FDA event 98554

Follow VOCSN V+Pro package

What happened

Who may be affected

What the official notice recommends

Affected products and models

Timeline

VOCSN V+Pro package recall — FDA event 98554

Follow VOCSN V+Pro package

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