Class I — Serious Health Hazard

Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.

LifeVent EVO2. Model Number: SP2100X26B. Intended for invasive and non-invasive Recalled by Philips Respironics, Inc. Due to Potential for in-line nebulizer configuration in certain locations...

Date: October 7, 2024
Company: Philips Respironics, Inc.
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Philips Respironics, Inc. directly.

Affected Products

LifeVent EVO2. Model Number: SP2100X26B. Intended for invasive and non-invasive ventilation of pediatric through adult patients weighing at least 2.5 kg in institutional, home, and non-emergency transport settings.

Quantity: 1,244 units

Why Was This Recalled?

Potential for in-line nebulizer configuration in certain locations to result in aerosol deposit accumulation on the device's internal flow sensor, which could lead to inaccurate flow measurements.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Philips Respironics, Inc.

Philips Respironics, Inc. has 85 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report