Philips Respironics, Inc.: Medical Device Recall in 2021 - (Recall #: Z-1957-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

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

Product Classification:

Class I

Date Initiated: June 14, 2021

Date Posted: July 21, 2021

Recall Number: Z-1957-2021

Event ID: 88071

Reason for Recall:

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.

Status: Ongoing

Product Quantity: 8047

Code Information:

All Devices manufactured before 26 April 2021, All device serial numbers. Material Numbers 1111181 1111182 1111178 1140184 1135427 1143671

Distribution Pattern:

Worldwide distribution including US Nationwide, Argentina, Australia, Brazil, Canada, China, France, Germany, Italy, Japan, Korea, and Latin America.

Voluntary or Mandated:

Voluntary: Firm initiated