Philips Respironics Continuous Ventilators Recalled for Foam Degradation Risk
Philips Respironics is recalling approximately 255,810 continuous ventilators because polyurethane foam may degrade into particles that could be inhaled or ingested, or release 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: FDA Class I recall carries a minimum severity of Severe per the rubric. Although no illnesses or injuries have been reported, the potential for serious harm through inhalation and ingestion of foam particles and chemical exposure justifies the Class I designation.
Plain-English summary
Philips Respironics, Inc. is recalling approximately 255,810 units of continuous ventilators including the Trilogy 100, Trilogy 200, Garbin Plus, Aeris, and LifeVent models. All devices manufactured before April 26, 2021 are affected, with worldwide distribution including the United States, Argentina, Australia, Brazil, Canada, China, France, Germany, Italy, Japan, Korea, and Latin America.
The polyester-based polyurethane (PE-PUR) foam used in these devices may degrade into particles over time. These particles may enter the device's air pathway and be inhaled or ingested by the user. Additionally, the foam may off-gas certain chemicals into the air pathway.
Patients using affected devices should consult with their healthcare provider regarding this recall. Additional information and instructions are available from the FDA and Philips Respironics.
The recalled product
- Product
- Trilogy 100, Trilogy 200, Garbin Plus, Aeris, LifeVent Continuous Ventilators.
- Manufacturer
- Philips Respironics, Inc.
- Affected units
- 255,810
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All Devices manufactured before 26 April 2021
Distribution
Distributed nationwide across the United States.
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.
See all 3 products in this recall →Related recalls
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