Philips Respironics, Inc.: Medical Device Recall in 2021 - (Recall #: Z-1972-2021)

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:

Philips Respironics E30 with Humidifier, Continuous Ventilator, Minimum Ventilatory Support, Facility Use; Product Numbers DSX9999H11, INX9999H19, RINX9999H19 The Philips Respironics E30 ventilator is intended to provide invasive and non-invasive ventilatory support for individuals with Respiratory Insufficiency. It is specifically for the care of adult and pediatric patients >7 years of age and >18kgs.

Product Classification:

Class I

Date Initiated: June 14, 2021

Date Posted: July 21, 2021

Recall Number: Z-1972-2021

Event ID: 88058

Reason for Recall:

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

Status: Ongoing

Product Quantity: 15,357,775 (10,307,186 in US, 5,039,748 OUS) in total

Code Information:

All Serial Numbers Material Numbers: DSX9999H11 INX9999H19 RINX9999H19

Distribution Pattern:

Global distribution

Voluntary or Mandated:

Voluntary: Firm initiated