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.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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.
- 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
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.
See all →- SevereTrilogy EV300 obstruction alarm may take up to four breaths
FDA (Devices) · 2026-04-08
- SevereTrilogy Evo O2 obstruction alarm may take up to four breaths
FDA (Devices) · 2026-04-08
- SevereTrilogy Evo obstruction alarm may take up to four breaths
FDA (Devices) · 2026-04-08
- SevereTrilogy Evo Universal obstruction alarm may take up to four breaths
FDA (Devices) · 2026-04-08
- SevereTrilogy EV300 ventilator recalled as Class I over tidal volume
FDA (Devices) · 2026-04-01
Same hazard · voc off gassing
See all →- SeverePhilips OmniLab Advanced+ Ventilation Devices Recalled for Plastic Off-Gassing
FDA (Devices) · 2022-09-14
- SeverePhilips OmniLab Advanced+ sleep apnea devices recalled for off-gassing
FDA (Devices) · 2022-09-14
- SeverePhilips BiPAP A30 respiratory device motor assemblies recalled for VOC off-gassing
FDA (Devices) · 2022-09-14
Similar recalls
- SeverePhilips Respironics BiPAP V30 Auto Recall for Non-Conforming Plastic Material
FDA (Devices) · 2021-06-02
- SeverePhilips Respironics BiPAP A30 Ventilator Recall for Motor Assembly Defect
FDA (Devices) · 2021-06-02
- SevereBiPAP V30 Auto ventilators are not indicated for respiratory failure
FDA (Devices) · 2025-07-09
- SevereBiPAP V30 Auto Ventilator May Interrupt Therapy During Malfunction Alarm
FDA (Devices) · 2024-05-29
- SeverePhilips Respironics BiPAP ventilators recalled for foam degradation and off-gassing
FDA (Devices) · 2021-07-21
- SeverePhilips Respironics BiPAP A40 Ventilators Recalled for Motor Assembly Defects
FDA (Devices) · 2021-06-02