Philips OmniLab Advanced+ Ventilation Devices Recalled for Plastic Off-Gassing
Philips Respironics is recalling certain Philips OmniLab Advanced+ noninvasive ventilation devices due to motor assemblies with nonconforming plastic that can off-gas volatile organic compounds (VOCs). This is an FDA Class I recall.
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. Per the severity rubric, FDA Class I recalls cannot be scored below 4 (Severe). While no illnesses or deaths have been reported, the product is a medical device for respiratory support, and the nonconforming plastic material presents a potential health risk through VOC off-gassing.
Plain-English summary
Philips Respironics, Inc. is recalling Philips OmniLab Advanced+ Intl (Flow Gen) noninvasive ventilation devices used to provide breathing support for patients with obstructive sleep apnea syndrome and respiratory insufficiency.
The recall affects devices with motor assemblies manufactured from nonconforming plastic that contributes to the release of volatile organic compounds (VOCs). VOCs are chemical emissions that may present a health risk to device users.
Approximately 37 units have been identified as affected. The devices were distributed across multiple US states and internationally, including 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, UAE, and the UK.
Owners of affected devices should contact Philips Respironics, Inc. for information regarding device replacement or repair options.
The recalled product
- Product
- Philips OmniLab Advanced+ Intl (Flow Gen), Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apnea syndrome (OSA) and respiratory insufficiency.
- Manufacturer
- Philips Respironics, Inc.
- Hazard
- voc-off-gassing
- defective-motor-assembly
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: 606959029415
- 606959028791
- Model No.: 1109582
- 1109585
- Serial No. L28664715858F
- L286647269D7C
- L286647278CF5
- L28870204F469
- L28870206D77B
- L28870207C6F2
- L288702092F8C
- L28870210AB95
- L28870211BA1C
- L288702128887
- L28870214EDB1
- L28870215FC38
- L28870216CEA3
- L28870217DF2A
- L290843744520
- L2908437554A9
Distribution
Distributed in 42 states:
- AK
- AL
- AR
- AZ
- CA
- CO
- CT
- DE
- FL
- GA
- IA
- ID
- IL
- IN
- KS
- KY
- LA
- MA
- ME
- MI
- MN
- MO
- MS
- MT
- NC
- ND
- NH
- NJ
- NV
- NY
- OH
- OK
- OR
- PA
- TN
- TX
- VA
- VT
- WA
- WI
- WV
- WY
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