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Frequently Asked Questions on Philips Recall of PAP Devices

When was the recall initiated?

On June 14, 2021, Philips initiated a voluntary U.S. recall (and an international field safety notice) for specific Philips Respironics models of continuous positive airway pressure (CPAP), bilevel positive airway pressure (BPAP), and mechanical ventilator devices. The recall was to address potential health risks related to the polyester-based polyurethane (PE-PUR) sound abatement foam used in certain devices breaking down and, causing users to inhale particles and fumes. Since this initial voluntary recall, the FDA identified hazards sufficient to warrant a Class 1 Recall, the most serious type of recall.

What were the risks associated with the recalled devices?

Risks of using the recalled devices might include airway inflammation; skin, eye, and respiratory tract irritation (including upper airway irritation); headache; asthma; toxic carcinogenic effects; cough; chest pressure; or sinus infection. Philips recommended users of their recalled BPAP and CPAP machines discontinue treatment.

How has the FDA responded to the recall?

On June 30, 2021, the FDA issued a safety communication urging patients who use a recalled device to talk to their health care provider to decide on a suitable treatment for their condition. The FDA worked with Philips to evaluate the issue and the company’s corrective actions for the past several years, issuing various statements for both patient safety and provider resources.

On April 9, 2024, a federal district court entered a consent decree against Philips Respironics, including key provisions aimed at prioritizing patient relief and ensuring the company’s regulatory compliance. Details of the consent decree are available. On April 29, 2024 Philips agreed to pay $1.1 billion to resolve the personal injury litigation and the medical monitoring class action lawsuits. The settlement also covers medical monitoring claims for potential future risks. The company, while not admitting fault, reached a settlement to address uncertainties and frustrations caused by delays in repairing or replacing the machines. This settlement marks a significant step in resolving one of the largest medical devices recalls in history. The decree also mandates a Recall Remediation Plan to provide affected patients with replacement devices, reworks, or partial refunds. Philips must also comply with good manufacturing practices and reporting standards before resuming full operations.

The settlement follows a separate $479 million settlement reached in September 2023 over economic losses to the patients and medical equipment sales companies that financed replacement devices. Philips has halted U.S. sales of new devices which in turn has caused a shortage of equipment.

What resources are available to support clinicians?

Philips has provided safety information and recall details for clinicians, including how they will be supporting the maintenance and transition of the effected devices. The American Academy of Sleep Medicine also has resources available for clinicians to understand the impacts of the recall.

How are patients being supported?

Patients need to work with their healthcare providers to understand what medical devices are included in the recall and what options are available for their individualized treatment. In some cases, due to limited supply or other issues, the benefit of continued usage of the devices may outweigh the risks.

How can I contact Philips with questions?

Help Needed Audience Phone Number
Recall Registration Questions DME, Patient 1 (877) 907-7508
Recall Post Remediation Questions Patient 1 (833) 262-1871
Prescription Assistance Clinician, Patient 1 (888) 511-2797
Mask Magnet Recall DME, Patient 1 (877) 387-3311
General Complaints DME, Patient 1 (800) 345-6443

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