Medical technology firm Masimo has filed a lawsuit against US Customs and Border Protection (CBP), arguing that the agency unlawfully cleared Apple to reactivate a blood-oxygen monitoring feature on its Apple Watch models. Masimo says the feature still infringes on its patents and that CBP exceeded its authority in reversing an earlier ban.
Masimo Challenges CBP’s Reversal
The lawsuit, filed in the US District Court for the District of Columbia, claims CBP violated the Administrative Procedure Act and due process protections when it issued an internal advice ruling on August 1. According to Masimo, the agency overturned its own January decision without notifying the company or allowing it to respond. That earlier decision had permitted Apple Watch imports only if the blood-oxygen function was disabled.
Apple announced on August 14 that a software update would restore the feature for US users by shifting the oxygen-level calculations to paired iPhones instead of the watch itself. Masimo says it learned of the agency’s reversal only after Apple’s announcement, calling the move an “extraordinary departure” from CBP’s established practice of requiring adversarial proceedings.
In its supporting brief, Masimo warned that “each passing day that this unlawful ruling remains in effect irreparably deprives Masimo of its right to be free from unfair trade practices and to preserve its competitive standing in the US marketplace.”
Ongoing Patent Dispute
The International Trade Commission (ITC) ruled in October 2023 that Apple Watches infringed two Masimo patents related to non-invasive pulse oximetry. That ruling led to a limited exclusion order blocking import of the devices with the disputed technology. Apple has appealed the ITC decision, with the case pending before the Federal Circuit.
Masimo also noted the timing of Apple’s investment pledges in the United States around the CBP reversal. According to Bloomberg Law, Apple announced another $100 billion in commitments ahead of an August 6 Oval Office event, where CEO Tim Cook highlighted $2.5 billion for Corning glass production. The filing pointed out these announcements while questioning why CBP suddenly allowed Apple to restore the feature despite the ITC’s prior findings.
Masimo is asking the court for a temporary restraining order and preliminary injunction to block the August 1 ruling and reinstate the January restriction. The case is Masimo Corp. v. US Customs and Border Protection, D.D.C., No. 25-cv-2749, complaint filed August 20, 2025.
