The Recall Desk
SevereFDA (Devices)·Z-1957-2021·Announced 2021-07-21

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.

What this means for you

Illness, injury, or structural failure has been reported. 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.
Category
Medical Device — Respiratory / Ventilator
Hazard
  • foam-degradation
  • inhalation-hazard
  • off-gassing

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.

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