Philips Respironics ventilators recalled due to foam degradation and chemical release
Philips Respironics ventilators and respiratory support devices are being recalled because polyurethane foam components may degrade into particles that can be inhaled or ingested, and the foam may release harmful chemicals.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class I recall, which per the severity rubric requires a minimum score of 4. No illnesses or injuries are reported in the source text. The hazard—polyurethane foam degradation that can be inhaled or ingested in critical respiratory support devices—poses serious risk to vulnerable patients.
Plain-English summary
Philips Respironics, Inc. is recalling multiple ventilator and respiratory support device models distributed worldwide. The recalled products include DreamStation ASV, DreamStation ST, AVAPS, SystemOne ASV4, C-Series ASV, C-Series S/T and AVAPS, OmniLab Advanced+ Continuous Ventilator, and the Philips Respironics E30 ventilator. These devices are intended to provide invasive and non-invasive ventilatory support for individuals with respiratory insufficiency, including adults and pediatric patients over 7 years of age and weighing more than 18 kg.
The recalled devices contain polyester-based polyurethane foam components that may degrade into particles. These degraded particles may enter the device's air pathway and could be inhaled or ingested by the user. Additionally, the polyurethane foam may release certain chemicals.
Approximately 15.3 million units have been distributed globally, including 10.3 million in the United States and 5.0 million outside the United States. Patients and healthcare providers using these recalled devices should contact their healthcare provider or Philips Respironics for information about this recall and available options.
The recalled product
- Product
- DreamStation ASV, DreamStation ST, AVAPS, SystemOne ASV4, C-Series ASV, C-Series S/T and AVAPS, OmniLab Advanced+ Continuous Ventilator, Non-life Supporting The Philips Respironics E30 ventilator is intended to provide invasive and non-invasive ventilatory support for…
- Manufacturer
- Philips Respironics, Inc.
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 3 recalled by Philips Respironics, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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