FDA Issues Update on Most Serious Recall for Certain Ventilators

So far, 13 injuries and eight deaths have been reported in connection with the devices, the FDA says.

A U.S. Food and Drug Administration (FDA) sign is seen outside the agency's White Oak campus in Silver Spring, Md., on July 17, 2025. Issam Ahmed/AFP via Getty Images

The Food and Drug Administration (FDA) issued a notice warning that medical ventilators made by Philips Respironics are still under a Class I recall due to the potential for serious injury or death.

The agency noted that the recall notice for the company’s V30, A30, and A40 ventilators, which are used for obstructive sleep apnea (OSA), primarily “involves correcting devices and does not involve removing them from where they are used or sold.”

So far, according to the health agency, 13 injuries and eight deaths have been reported in connection with the devices.

In the notice on Aug. 4, the FDA said that problems with the firm’s A30, A40, and V30 Auto ventilators need a correction. The company in March 2024 warned its customers of an urgent medical device recall that made several recommendations.

According to the notice, Philips Respironics says it is updating use instructions on the ventilators due to the risk of failure on the device’s inoperative alarm, which can cause a loss or interruption in therapy. The FDA notice said the recall still involves correcting the devices.

“If interruptions of therapy can be tolerated and the ventilator inoperative alarm occurs, the patient/caregiver will have instructions to remove the patient from the device and to place them on an alternative device,” the FDA said in the notice, which cited the new instructions from Philips.

If the “interruptions of therapy cannot be tolerated, the patients and caregivers are instructed to provide alternate ventilation AND contact the Equipment Supplier for immediate device alternative.”

Problems with the ventilator, the FDA said, “can result in therapy interruption or loss, potentially leading to hypoventilation, hypoxemia, hypercarbia, respiratory failure, or death in vulnerable patients.”

Philips updated the use instructions for the ventilators because, due to the issue, the device may reboot intermittently for five to 10 seconds before either restarting with the same patient settings or restarting with the default settings from the factory.

“In these cases, the device stops therapy with a blank screen and single audible alert before restarting,” the notice said.

The V30 device is used in either health-care settings or hospitals and not used for life support, but “can be used for intra-facility support,” while the A30 is used in the home and clinical settings such as sleep labs, hospitals, and intermediate care facilities. The A40 is “intended for home and clinical settings, including portable applications like wheelchairs and gurneys,” said the notice.

A Class I recall is considered by the FDA to be the most serious, indicating that there is a possibility that the product could cause serious health problems or death.

Last year, Philips said it reached a $1.1 billion deal in the United States to settle lawsuits filed over some of its ventilators. The manufacturer did not admit any fault and said it reached an agreement to resolve any uncertainty over the cases. The payout also includes medical monitoring claims from patients who used the company’s devices and could be exposed to future risks.

Also last year, the company reached a settlement with the U.S. government that requires an overhaul of how it manufactures sleep apnea devices. The agreement also requires the company to replace or reimburse patients for recalled machines.

The Epoch Times contacted Philips for comment on Tuesday.

The Associated Press contributed to this report.