The Recall Desk
SevereFDA (Devices)·Z-1656-2022·Announced 2022-09-14

Philips BiPAP V30 Auto Respirators Recalled for VOC Off-Gassing Risk

Philips Respironics recalls 295 BiPAP V30 Auto respiratory devices due to motor assemblies with nonconforming plastic. These assemblies off-gas volatile organic compounds (VOCs) during device operation.

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 recalls carry a minimum severity of 4 per the rubric. Since no deaths, illnesses, or injuries are reported in the source, the score remains at Severe (4) rather than escalating to Critical (5).

Plain-English summary

Philips Respironics is recalling 295 BiPAP V30 Auto respiratory support devices. These prescription devices are designed to provide noninvasive ventilation support for patients with obstructive sleep apnea syndrome and respiratory insufficiency.

The motor assemblies in the recalled devices were manufactured with nonconforming plastic that contributes to off-gassing of volatile organic compounds (VOCs).

The affected units have been distributed domestically across all U.S. states and internationally to multiple countries including Australia, Canada, Germany, Japan, and the United Kingdom.

The recalled product

Product
Philips BiPAP V30 Auto, 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
Hazard
Affected units
295

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: 606959039377
  • 606959067936
  • Model No.: 1111155
  • 1111178
  • Serial No. N2908453138CE
  • N290845949213
  • N2909527493F9
  • N286646884854
  • N28664691CC4D
  • N28664692FED6
  • N28664693EF5F
  • N286646949BE0
  • N286646958A69
  • N28664696B8F2
  • N28664697A97B
  • N28664698518C
  • N286646994005
  • N286647005000
  • N286647014189
  • N286647027312

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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