The U.S. Food and Drug Administration (FDA) has announced a voluntary recall of Philips Respironics BiPAP ventilators over concerns that the devices may contain plastics contaminated with toxic chemicals known as Volatile Organic Compounds (VOCs).
Affected BiPAP devices were distributed between August 6, 2020 and September 1, 2021 and include:
- A-Series BiPAP A30 (Ventilator)
- A-Series BiPAP A40 (Ventilator)
- A-Series BiPAP V30 (Auto Ventilator)
- OmniLab Advanced+
Some of the same devices may have been a part of a previous recall over polyester-based polyurethane (PE-PUR) foam degradation. If previously recalled devices were not repaired or replaced, they may place the user at additional risk.
People who used or were injured by a Philips BiPAP ventilator or autoventilator breathing machine may be eligible for compensation.
BiPAP Machines Recalled Due to Possible Plastic VOC Contamination
On August 29, 2022, the U.S. Food and Drug Administration (FDA) issued a safety communication regarding a voluntary recall of certain Philips BiPAP models which had been distributed from August 2020 to September 2021.
The recall includes Bilevel PAP (BiPAP) breathing devices which may contain plastic contaminated with volatile organic compounds (VOCs). The plastic may also cause machines to stop working, which may increase a risk of complications or even death if the machine fails.
VOCs are known to be toxic, particularly when inhaled or absorbed through mucous membranes. Symptoms of VOC exposure include:
- Nasal irritation
- Lung irritation and inflammation
- Eye irritation
- Skin sensitivity
- Nausea or vomiting
The FDA has estimated that Philips distributed 1,700 affected machines worldwide, 386 of which were issued in the U.S. Affected devices may be present in homes, private care settings and institutions like hospitals and nursing facilities, depending on the model.
No deaths have been associated with this recall, but failure of an affected device is potentially serious.
Previous Philips CPAP and BiPAP Recall Not Related
A previous, June 2021 recall of thousands of Philips CPAP, BiPAP and ventilator devices is not related to the new August 2021 recall however, some of the same BiPAP machines may be affected.
In June 2021, the FDA issued a massive recall involving thousands of Philips CPAP, BiPAP and Ventilator devices over reports of degrading PE-PUR sound-abatement foam liners. The June 2021 recall was upgraded to Class I, indicating that the devices could pose serious risk of injury or death. The PE-PUR recall has been associated with thousands of adverse events, including a number of deaths which have been reported to the FDA.
Philips is facing hundreds or thousands of lawsuits due to the PE-PUR foam degradation and now may be facing additional lawsuits over plastic contamination.
Philips BiPAP Plastics Recall FDA Guidance
The August 2022 Philips BiPAP Plastic Contamination Recall currently affects 386 devices distributed in the U.S. between August 2020 and September 2021, however past Philips recalls have later been expanded to include additional units.
Some of the devices included in the current recall may have also been a part of the separate PE-PUR recall. FDA recommendations for actions to be taken may be determined by previous repair and replacement arrangements.
If the recalled devices were repaired or replaced as part of the prior PE-PUR recall, they may not require additional attention. People whose devices were a part of the prior recall but have not been repaired or replaced should discuss treatment plans with their healthcare provider and register the device with Philips.
Facilities using Philips BiPAP ventilators including the A-Series BiPAP V30 (Auto Ventilator) and OmniLab Advanced+ machines which were not previously recalled, are advised to replace them with alternative, unaffected devices immediately. Affected machines should be quarantined and corrected or replaced through arrangements with Philips Respironics. People who used a Philips A-Series A30, A40 or V30 or OmniLab Advanced BiPAP machine in home or institutional settings, may have been placed at risk of injury or death. If you were affected by the Philips Respironics BiPAP Plastic Contamination Recall, you may be eligible for compensation.
Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.