On July 22, the FDA announced Class 1 recalls for over 3.5 million ventilators and CPAP and BiPAP machines that were sold since 2009 due to serious health risks.
Philips recalled the breathing machines after at least 1,200 complaints and more than 100 injuries were reported to the FDA, according to MassDevice.
The health hazards are linked to toxic PE-PUR foam (Polyester-Based Polyurethane), which is used to reduce noise from the machine.
Unfortunately, PE-PUR foam can also disintegrate into tiny black particles that get into the air that a user breathes, posing a risk of cancer. PE-PUR foam can also “off-gas” highly toxic chemicals.
People who use the recalled breathing machines can develop a wide range of health problems, including cancer, according to the FDA:
“The exposure to debris or chemicals could cause serious adverse events in patients such as irritation (skin, eye, and respiratory tract), inflammation, headache, asthma, hypersensitivity, nausea/vomiting, adverse effects to other organs (e.g., kidneys and liver) and toxic carcinogenic effects.”
The Class 1 recalls include the following Philips breathing machines:
- Mechanical ventilation devices: Trilogy 100, Trilogy 200, Garbin Plus, Aeris, LifeVent 200, BiPAP V30, BiPAP A30/Hybrid/A40
- Continuous Ventilator, Minimum Ventilatory Support, Facility Use: Philips Respironics E30 with Humidifier
- Continuous Ventilator, Non-life Supporting devices: DreamStation ASV, DreamStation ST, AVAPS, SystemOne ASV4, C-Series ASV, C-Series S/T and AVAPS, OmniLab Advanced+
- Noncontinuous Ventilators: SystemOne (Q-Series), DreamStation, DreamStation Go, Dorma 400, Dorma 500, and REMstar SE Auto)
Source: Philips CPAP recall is Class I