Philips BiPAP V30 Auto Ventilator Recalled for Incorrect Indication Labeling
Philips Respironics recalled 5,958 BiPAP V30 Auto Ventilators worldwide due to incorrect labeling indicating use for respiratory failure patients. The device is not indicated for respiratory failure.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: This is an FDA Class I recall. Per the severity rubric, FDA Class I recalls are classified as Critical regardless of other factors.
Plain-English summary
Philips Respironics is recalling 5,958 BiPAP V30 Auto Ventilators worldwide, including the United States, Guam, Puerto Rico, and more than 50 other countries. The BiPAP V30 is a non-invasive ventilator intended to provide ventilatory support for pediatric and adult patients weighing over 10 kg.
The devices were distributed with labeling that incorrectly indicated they are appropriate for use in patients with respiratory failure. The BiPAP V30 is not indicated for respiratory failure patients and should not be used in this patient population.
Healthcare facilities and individuals currently using this device should review the device labeling to confirm appropriate indications before continued use. Clinicians should ensure the device is only used in patients for whom it is properly indicated. Patients and healthcare providers should consult with Philips Respironics or their healthcare provider with any questions about appropriate use of this device.
The recalled product
- Product
- BiPAP V30 Auto Ventilator. Intended to provide non-invasive ventilatory support for pediatric and adult patients weighing over 10 kg.
- Manufacturer
- Philips Respironics, Inc.
- Hazard
- incorrect-indication
- mis-labeling
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)
- Part Number 1111178
- UDI: 0060959049635
- Serial No. N2068642229E4
- N206864244CD2
- N206864255D5B
- N206864277E49
- N2068642886BE
- N206864299737
- N2068643102A7
- N20686432303C
- N2068643321B5
- N20686434550A
- N206864354483
- N206864367618
- N206864376791
- N206864389F66
- N206864398EEF
- N206864405E26
- N206864414FAF
- N206864427D34
Distribution
Distributed nationwide across the United States.
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