FDA hands Philips its 5th Class I recall of the year for faulty ventilators

Philips’ respiratory device-focused Respironics business has been in the hot seat for well over a year now, ever since it identified a potentially fatal safety issue with the sound-muffling foam of around 5.5 million of its CPAP and BiPAP machines and other ventilators.

Even with that massive recall—and its equally massive repair-and-replace program—well underway, the company has continued to uncover even more issues within its Respironics lineup, resulting in a handful of additional recalls this year alone.

The latest of these, which began at the end of August and concerns several models of Philips’ BiPAP machines, is now the fifth this year to receive the FDA’s most serious rating, denoting an increased risk of serious injury or death. The agency handed down the Class I tag on Friday.

The recall concerns just under 1,700 devices distributed around the world between August 2020 and the beginning of September 2021, about 400 of which were sold in the U.S. It spans only certain serial numbers of the A30, A40 and V30 models of Philips’ BiPAP machines, as well as the OmniLab Advanced+ titration device.

According to the recall notice, the affected machines have been found to potentially contain plastic pieces that have been contaminated with a non-compatible material. Not only could that plastic cause the machine to suddenly fail and stop working while in use, but if it’s located within the device’s motor, it could release volatile organic compounds, or VOCs.

If the VOCs end up in a user’s airflow, it could lead to health issues like headache, dizziness, eye and skin irritation, allergic and immune system reactions, nausea or other “toxic and cancer-causing effects,” per the FDA.

To date, neither Philips nor the FDA has received any reports of serious injury or death linked to the contaminated plastic.

In the meantime, however, the devicemaker has asked users of the affected BiPAP machines to stop using them immediately. The devices should be either replaced with an alternative device or registered with Philips for a correction—excluding those that have already been replaced or repaired in the company’s major ongoing ventilator recall since the plastic pieces are also being replaced in those efforts.