medical Class I Updated 2021-07-21

Philips Respironics, Inc. recalls A-Series BiPAP Hybrid A30 (not marketed in US), A-Series BiP

Recalled Product

A-Series BiPAP Hybrid A30 (not marketed in US), A-Series BiPAP V30 Auto Continuous Ventilator, Minimum Ventilatory Support, Facility Use


Hazard / Issue

The polyester-based polyurethane (PE-PUR) foam may degrade into particles which may enter the devices air pathway and be ingested or inhaled by the user, and the PE-PUR foam may off-gas certain chemicals.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: All Devices manufactured before 26 April 2021, All device serial numbers. Material Numbers 1111181 1111182 1111178 1140184 1135427 1143671
View official government recall

Looking for safe alternatives?

Browse certified-safe products in this category on Amazon →