The Recall Desk
SevereFDA (Devices)·Z-1654-2022·Announced 2022-09-14

Philips BiPAP A30 respiratory device motor assemblies recalled for VOC off-gassing

Philips Respironics recalls Philips BiPAP A30 respiratory devices due to motor assemblies with nonconforming plastic that off-gases volatile organic compounds (VOCs). Patients should contact the manufacturer immediately.

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: FDA Class I recall requires minimum severity score of 4 per the rubric. No deaths or reported serious injuries have been documented. The hazard—volatile organic compound off-gassing from motor assemblies in a respiratory device used by vulnerable patients—constitutes a significant health risk warranting Severe classification.

Plain-English summary

Philips Respironics is recalling Philips BiPAP A30 respiratory devices, which provide noninvasive ventilation support for patients with obstructive sleep apnea syndrome (OSA) and respiratory insufficiency. The motor assemblies in these devices were manufactured with nonconforming plastic.

The nonconforming plastic contributes to off-gassing of volatile organic compounds (VOCs). The FDA classified this as a Class I recall, the most serious medical device classification, indicating a reasonable probability that the recalled product could cause serious adverse health consequences or death.

Approximately 146 units are affected domestically across all U.S. states, with an additional 30 units identified in January 2024. The devices have also been distributed internationally to Australia, Austria, Bangladesh, Brazil, Canada, China, Denmark, Egypt, France, Germany, Hong Kong, Hungary, India, Israel, Italy, Japan, Malaysia, Mexico, Myanmar, Philippines, Qatar, Serbia, Singapore, Taiwan, Thailand, Turkey, United Arab Emirates, and the United Kingdom.

Patients using Philips BiPAP A30 devices should contact Philips Respironics immediately for guidance on replacement, repair, or return of their devices. Healthcare providers should inform affected patients about this recall and ensure appropriate follow-up care.

The recalled product

Product
Philips BiPAP A30, Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apnea syndrome (OSA) and respiratory insufficiency.
Manufacturer
Philips Respironics, Inc.
Category
Medical Device — Respiratory support device
Hazard

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 (20)

  • UDI-DI:606959042667
  • 606959042681
  • 606959042698
  • 606959042728
  • 606959067585
  • 606959067530
  • Model No.: 1109581
  • 1109582
  • 1109585
  • 1109588
  • 1109589
  • 1109590
  • 1109594
  • 1109596
  • 1109598
  • 1109601
  • 1111124
  • 1111150
  • 1111155
  • 1111169

Distribution

Distributed in 42 states:

Part of a larger recall action

This product is one of 6 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 6 products in this recall →

Related recalls

Same manufacturer · Philips Respironics, Inc.

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Same hazard · voc off gassing

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