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.

BiPAP A40 Ventilator. Used to provide noninvasive ventilation support for Recalled by Philips Respironics, Inc. Due to This device does not indicate for use in...

Date: May 9, 2025
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

BiPAP A40 Ventilator. Used to provide noninvasive ventilation support for the purpose of treating adult and pediatric patients. BiPAP A40 Pro - sold OUS

Quantity: 6 units in US 67534 OUS

Why Was This Recalled?

This device does not indicate for use in patients with respiratory failure.

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