The Recall Desk
SevereFDA (Devices)·Z-2036-2025·Announced 2025-07-09

BiPAP A30 and BiPAP Hybrid A30 Ventilators Recalled by Philips

Philips Respironics is recalling BiPAP A30 and BiPAP Hybrid A30 ventilators. The devices do not have an indication for use in patients with respiratory failure.

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 of a medical device, which requires a minimum severity score of 4 per the rubric. The hazard involves a labeling or indication defect on a critical-use respiratory device that could lead to misuse in contraindicated patient populations.

Plain-English summary

Philips Respironics, Inc. is recalling BiPAP A30 and BiPAP Hybrid A30 ventilators. These devices are intended to provide noninvasive ventilation support in adult and pediatric patients weighing more than 10 kg. According to the FDA, the devices do not indicate for use in patients with respiratory failure.

The recall affects approximately 22,416 units in the United States, including Guam and Puerto Rico, as well as 49 units distributed outside the United States to multiple countries worldwide.

If you have one of these devices, contact Philips Respironics, Inc. for instructions on how to proceed. Consumers should not use the device for patients with respiratory failure.

The recalled product

Product
BiPAP A30 Ventilators. Intended to provide noninvasive ventilation support in adult and pediatric patients weighing more than 10 kg. BiPAP Hybrid A30 Ventilator. Used to provide noninvasive ventilation support for the purpose of treating adult and pediatric patients.
Manufacturer
Philips Respironics, Inc.
Category
Medical Device — Respiratory / Ventilation
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)

  • BiPAP A30 Part No. 1111143
  • 1111144
  • CN1111143
  • 1111145
  • 1111147
  • 1111149
  • 1111148
  • 1111150
  • 1116155
  • BR1111143
  • 1111144M
  • 1111144L
  • 1111144V
  • R1076491
  • 1111154
  • R1111143
  • 1101109
  • 1109594
  • 1076540
  • 1076581

Distribution

Distributed nationwide across the United States.

The notice also names 10 states specifically:

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

Same manufacturer · Philips Respironics, Inc.

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Same hazard · contraindicated use

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