Philips Respironics BiPAP ventilators recalled for foam degradation and off-gassing
Philips Respironics BiPAP ventilators' polyurethane foam may degrade into particles that could be inhaled or ingested, or off-gas certain chemicals. About 8,047 devices worldwide are affected.
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 rubric requires a minimum severity of Severe (4). No deaths or serious injuries have been reported in the source text, so the score remains at 4 rather than escalating to Critical (5).
Plain-English summary
Philips Respironics A-Series BiPAP ventilators are subject to a Class I recall due to potential hazards with the polyester-based polyurethane (PE-PUR) foam used in the devices. The foam may degrade and release particles into the air pathway, which users could inhale or ingest. The foam may also off-gas certain chemicals.
Approximately 8,047 devices worldwide are affected by this recall. The devices were distributed in the United States and internationally, including Argentina, Australia, Brazil, Canada, China, France, Germany, Italy, Japan, Korea, and Latin America. All devices manufactured before April 26, 2021, are subject to the recall.
For information regarding this recall, consumers should contact Philips Respironics, Inc.
The recalled product
- Product
- A-Series BiPAP Hybrid A30 (not marketed in US), A-Series BiPAP V30 Auto Continuous Ventilator, Minimum Ventilatory Support, Facility Use
- Manufacturer
- Philips Respironics, Inc.
- Affected units
- 8,047
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.
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