BiPAP A30 and BiPAP Hybrid A30 Ventilators Recalled by Philips
Philips Respironics is recalling BiPAP A30 and BiPAP Hybrid A30 ventilators. The devices do not have an indication for use in patients with respiratory failure.
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: This is an FDA Class I recall of a medical device, which requires a minimum severity score of 4 per the rubric. The hazard involves a labeling or indication defect on a critical-use respiratory device that could lead to misuse in contraindicated patient populations.
Plain-English summary
Philips Respironics, Inc. is recalling BiPAP A30 and BiPAP Hybrid A30 ventilators. These devices are intended to provide noninvasive ventilation support in adult and pediatric patients weighing more than 10 kg. According to the FDA, the devices do not indicate for use in patients with respiratory failure.
The recall affects approximately 22,416 units in the United States, including Guam and Puerto Rico, as well as 49 units distributed outside the United States to multiple countries worldwide.
If you have one of these devices, contact Philips Respironics, Inc. for instructions on how to proceed. Consumers should not use the device for patients with respiratory failure.
The recalled product
- Product
- BiPAP A30 Ventilators. Intended to provide noninvasive ventilation support in adult and pediatric patients weighing more than 10 kg. BiPAP Hybrid A30 Ventilator. Used to provide noninvasive ventilation support for the purpose of treating adult and pediatric patients.
- Manufacturer
- Philips Respironics, Inc.
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)
- BiPAP A30 Part No. 1111143
- 1111144
- CN1111143
- 1111145
- 1111147
- 1111149
- 1111148
- 1111150
- 1116155
- BR1111143
- 1111144M
- 1111144L
- 1111144V
- R1076491
- 1111154
- R1111143
- 1101109
- 1109594
- 1076540
- 1076581
Distribution
Part of a larger recall action
This product is one of 3 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 3 products in this recall →Related recalls
Same manufacturer · Philips Respironics, Inc.
See all →- SevereTrilogy Evo 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 Universal obstruction alarm may take up to four breaths
FDA (Devices) · 2026-04-08
- SevereTrilogy EV300 obstruction alarm may take up to four breaths
FDA (Devices) · 2026-04-08
- SevereTrilogy Evo O2 ventilator recalled as Class I over tidal volume
FDA (Devices) · 2026-04-01
Same hazard · contraindicated use
See all →- HighRadial Head Replacement System implant: contraindications added to safety instructions
FDA (Devices) · 2022-05-18
- HighSynthes Recalls Small Notch Titanium Reconstructive Plate Sets
FDA (Devices) · 2015-11-18
- ModerateIntegra Recalls Accell Evo3C Bone Matrix Due to Packaging Error
FDA (Devices) · 2014-07-02
- HighSynthes Small Notch Titanium Reconstructive Plate Recalled for Contraindicated Spine Use
FDA (Devices) · 2014-03-19
Similar recalls
- SevereBiPAP A30 Ventilator Recall: Risk of Therapy Interruption and Respiratory Failure
FDA (Devices) · 2024-05-29
- SeverePhilips Respironics BiPAP ventilators recalled for foam degradation and off-gassing
FDA (Devices) · 2021-07-21
- SeverePhilips BiPAP A-Series Ventilators Recalled for Foam Degradation Risk
FDA (Devices) · 2021-07-21
- SeverePhilips BiPAP A30 respiratory device motor assemblies recalled for VOC off-gassing
FDA (Devices) · 2022-09-14
- SeverePhilips Respironics BiPAP A30 Ventilator Recall for Motor Assembly Defect
FDA (Devices) · 2021-06-02
- SeverePhilips Respironics BiPAP A40 Ventilators Recalled for Motor Assembly Defects
FDA (Devices) · 2021-06-02