The Recall Desk
SevereFDA (Devices)·Z-1958-2021·Announced 2021-07-21

Philips BiPAP A-Series Ventilators Recalled for Foam Degradation Risk

Philips Respironics recalled 72,665 BiPAP A-Series ventilators worldwide. The foam in these devices may degrade into particles that could be inhaled or ingested, and may release chemicals.

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 recall received a Class I classification from the FDA, which requires a minimum severity score of 4. No deaths, injuries, or hospitalizations have been reported in the source material, preventing a higher classification.

Plain-English summary

Philips Respironics has recalled approximately 72,665 BiPAP A40 and A30 Continuous Ventilators due to a foam degradation issue. The devices are non-life-supporting ventilators distributed worldwide, including across the United States and multiple other countries.

The polyester-based polyurethane foam used in these devices may degrade over time into particles. These particles could potentially be inhaled or ingested by users. Additionally, the foam may release certain chemicals during this degradation process.

The affected devices were manufactured before April 26, 2021. Consumers who own or use these devices should contact Philips Respironics for further information and guidance. This is a Class I recall issued by the FDA.

The recalled product

Product
A-Series BiPAP A 40, A-Series BiPAP A30 Continuous Ventilator, Non-life Supporting
Manufacturer
Philips Respironics, Inc.
Category
Medical Device — Respiratory Equipment
Hazard
  • foam-particles
  • 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.

Related recalls

Same category