The Recall Desk
SevereFDA (Devices)·Z-1657-2022·Announced 2022-09-14

Philips OmniLab Advanced+ sleep apnea devices recalled for off-gassing

Philips Respironics is recalling 85 units of the OmniLab Advanced+ ventilation device due to motor assemblies containing nonconforming plastic that off-gasses volatile organic compounds.

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 device recall is classified as FDA Class I, a designation reserved for serious hazards. Per the severity rubric, FDA Class I status establishes a minimum rating of Severe (score 4).

Plain-English summary

Philips Respironics, Inc. is recalling 85 units of the Philips OmniLab Advanced+, a medical device designed to provide noninvasive ventilation support for patients with obstructive sleep apnea syndrome and respiratory insufficiency.

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

The recall affects devices distributed throughout the United States and internationally to multiple countries including Australia, Canada, China, Germany, Japan, and the United Kingdom. Specific model and serial numbers affected are detailed in the FDA recall notice.

The recalled product

Product
Philips OmniLab Advanced+, 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 — Sleep apnea ventilation device
Hazard
Affected units
85

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: 606959028791
  • Model No.: 1109581
  • Serial No. L28664716B714
  • L28664717A69D
  • L286647185E6A
  • L286647194FE3
  • L28664720F84A
  • L28664721E9C3
  • L28664722DB58
  • L28664723CAD1
  • L28664724BE6E
  • L28870984130F
  • L288709850286
  • L28870986301D
  • L288709872194
  • L28870988D963
  • L28870989C8EA
  • L288709904CF3
  • L288709915D7A
  • L288709926FE1

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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