What Is the Track Record of Philips Respironics in Product Recalls and Safety Concerns?

For U.S. medical equipment suppliers, Philips Respironics is a particularly important company to evaluate from a safety, fulfillment and replacement-service perspective. The company’s respiratory portfolio has a large installed base, but its record has also been significantly affected by the major 2021 recall involving CPAP, BiPAP and ventilator devices.

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The central issue was degradation of PE-PUR sound-abatement foam, which could release particles and volatile organic compounds into the device air pathway. The FDA said the recall affected 15 million devices worldwide.

What Is Philips Respironics and How Large Is the Business?

Philips Respironics is part of Royal Philips and has historically been a major supplier of sleep therapy, respiratory care and home-care devices, including CPAP, BiPAP and ventilators.

Royal Philips generated €17.8 billion in total sales in 2025, compared with €18.0 billion in 2024. Its Connected Care segment generated €5.08 billion, representing about 28% of group sales. Connected Care comparable sales increased 3% in 2025.

Sleep & Respiratory Care represented approximately 19% of Connected Care sales in 2025, indicating that Respironics remains commercially significant even though Philips has been restructuring the business following the recall.

Key Philips Financial and Recall Data

• Philips total sales, 2025: €17.8B
• Connected Care sales, 2025: €5.08B
• Connected Care comparable growth: 3%
• Sleep & Respiratory Care share of Connected Care: approximately 19%
• 2021 global recall: approximately 15M devices
• U.S. devices covered in Philips’ recall remediation plan: approximately 10.79M
• 2025 Respironics-related U.S. settlement payment: €1.025B

Philips reported that the €1.025 billion payment in 2025 related to Respironics recall-related medical monitoring and personal injury settlements in the U.S.

What Caused the Major Philips Respironics Recall?

The major recall began in June 2021.

Philips identified potential risks associated with the PE-PUR foam used to reduce noise and vibration in certain devices. The FDA explained that the foam could degrade and potentially release black particles or chemicals called VOCs, which could be inhaled or swallowed.

The issue affected multiple product families, including:

• DreamStation
• DreamStation Go
• SystemOne
• Trilogy
• BiPAP A-Series
• E30
• OmniLab Advanced+
• Certain other CPAP, BiPAP and ventilator models

The recall covered devices manufactured between 2009 and April 26, 2021 for the affected product families.

How Large Was the U.S. Recall?

The U.S. impact was substantial.

According to the Philips remediation-plan documentation available through the FDA, approximately 10.79 million U.S. devices were included in the recall scope.

The largest categories included:

• DreamStation CPAP: 4.15M devices
• SystemOne 60 Series Base: 2.63M
• SystemOne 50 Series Base: 2.18M
• DreamStation BiPAP: 517,270
• SystemOne 60 Series BiPAP: 373,441
• SystemOne 50 Series BiPAP: 338,711
• Trilogy 100/200 and related ventilators: 141,896

This scale is particularly relevant for medical equipment suppliers because a recall of this magnitude creates demand for patient identification, replacement equipment, setup, training, accessories and ongoing service.

What Happened With Replacement and Remediation?

Philips initiated a repair and replacement program, but the process became a significant regulatory concern.

In April 2023, the FDA stated that the number of replacement and remediated devices actually shipped to U.S. consumers was considerably lower than the 2.46 million replacement devices and repair kits Philips had previously reported on its website.

The FDA subsequently took stronger action.

In April 2024, a federal court entered a consent decree requiring Philips to implement a recall remediation plan agreed with the FDA. Depending on the device and circumstances, patients could receive a new device, a reworked/remediated device or, for certain devices, a partial refund.

Were There Additional Safety Issues After the Original Recall?

Yes.

The recall history did not end with the original 2021 action.

In 2022, Philips recalled certain reworked Trilogy 100, Trilogy 200 and Garbin Plus ventilators because of potential silicone-foam adhesion failure and residual PE-PUR foam debris.

The FDA classified this as a Class I recall, its most serious recall category, and reported 13,811 affected U.S. devices.

In 2023, Philips also recalled certain reworked DreamStation devices because of the risk of inaccurate or insufficient therapy. The FDA classified that recall as Class I and identified 1,088 U.S. devices.

In 2024, Philips updated instructions for certain BiPAP A30, A40 and V30 Auto devices because of potential interruptions or loss of therapy. The FDA again classified the action as Class I.

Philips Respironics Safety Timeline

What Does This Mean for a U.S. Medical Equipment Supplier?

For a non-manufacturing supplier, the key issue is not simply whether Philips has had recalls. It is how effectively the supplier can manage patients using Philips devices within the current regulatory and service environment.

The recall history makes several operational capabilities especially important:

• Serial-number and device-status verification
• Recall eligibility checks
• Replacement coordination
• Patient communication
• Device setup and configuration
• Patient/caregiver training
• Accessory replacement
• Documentation
• Escalation of safety concerns
• Backup-device planning
• Reliable fulfillment

For ventilator-dependent patients, the stakes can be particularly high. The FDA has instructed that where interruption of therapy cannot be tolerated, patients should have alternative ventilation available and suppliers should be contacted for an immediate alternative device.

What Is Philips Doing Differently Now?

Philips has been operating under significantly greater regulatory oversight.

The 2024 consent decree requires Philips to meet specific conditions before certain new CPAP and BiPAP devices can be produced and sold from affected facilities. It also requires independent review of testing related to the replacement silicone-based foam.

Philips’ 2025 annual report states that, until the relevant consent-decree requirements are met, Respironics will not sell new CPAP or BiPAP sleep-therapy devices or other respiratory-care devices in the U.S., although it continues to provide accessories, consumables, replacement parts and services.

This distinction is important for suppliers: replacement parts and service availability may remain relevant even while new-device sales are restricted.

Who Are the Actual Buyers and Users?

The respiratory-device ecosystem involves several stakeholders:

• Patients: primary users of CPAP, BiPAP and home respiratory devices
• Caregivers: important for setup and ongoing maintenance
• DME suppliers: responsible for fulfillment, setup and replacement services
• Hospitals and clinics: prescribe and coordinate therapy
• Sleep physicians: influence CPAP and BiPAP selection
• Pulmonologists: important for respiratory and ventilator therapies
• Medicare and private insurers: determine coverage and reimbursement
• Home-health organizations: support patients requiring respiratory care

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For your business model, DME suppliers and healthcare providers are particularly important operational partners, while patients and caregivers remain the ultimate service recipients.

What Should Suppliers Evaluate Before Working With Philips Respironics?

Given the recall history, suppliers should evaluate:

• Current U.S. product availability
• FDA recall status
• Replacement-device pathways
• Parts and accessory availability
• Warranty support
• Technical escalation procedures
• Patient training requirements
• Insurance and Medicare requirements
• Documentation and compliance
• Alternative-device availability
• Response times for safety issues

The most important consideration is continuity of therapy. A supplier should have a clear process for what happens when a patient’s device is recalled, fails, requires replacement or cannot safely provide therapy.

How Does the Track Record Affect Philips’ Position?

Philips Respironics remains a major respiratory-care name, but its 2021 recall and subsequent regulatory actions represent a significant negative mark on its safety and operational track record.

At the same time, Philips continues to generate substantial revenue from its broader healthcare technology portfolio and reported €17.8B in 2025 group sales. The company also reported a €1.025B payment related to Respironics recall-related U.S. settlements, demonstrating that the financial consequences remain material.

For a medical equipment supplier, therefore, Philips should be evaluated through two lenses:

Product opportunity + operational risk.

The critical question is whether the company’s current regulatory compliance, replacement infrastructure, service availability and product reliability meet the requirements of the patients and payers you serve.

How Towards Healthcare Can Help You?

Towards Healthcare Research & Consulting can help DME suppliers, healthcare organizations and investors evaluate respiratory-device companies through:

• Product recall and safety intelligence
• Competitor benchmarking
• FDA regulatory tracking
• Product and device portfolio analysis
• Revenue and sales tracking
• DME and healthcare-buyer identification
• Insurance and reimbursement intelligence
• Replacement-service benchmarking
• Patient and provider needs analysis
• Regional opportunity assessment
• Technology and product-development tracking

The objective is to help suppliers understand which respiratory-device manufacturers offer the strongest combination of product reliability, regulatory compliance, fulfillment, replacement support and long-term patient service.