US Customs and Border Protection unlawfully let
CBP exceeded its authority in an Aug. 1 internal advice ruling that overturned its own January decision without notice or input from Masimo, the medical-device maker said in a complaint filed Wednesday in the US District Court for the District of Columbia. Masimo brought claims under the Administrative Procedure Act and the Fifth Amendment’s due process clause.
Apple announced Aug. 14 that software updates would restore the blood-oxygen feature for US Apple Watch owners by shifting calculations to paired iPhones rather than the watch itself. Masimo said that was the first time it learned CBP had quietly reversed course two weeks earlier in an ex parte ruling, despite the agency’s policy that such decisions normally require both sides to be heard. The feature has been banned on US Apple Watches since the US International Trade Commission in October 2023 found it infringes claims in two Masimo patents.
Masimo’s complaint notes the timing of Apple investment pledges around CBP’s Aug. 1 ruling. Following more than $500 billion revealed earlier this year, Apple announced another $100 billion ahead of an Aug. 6 Oval Office event with President Donald Trump. At that event, Cook highlighted $2.5 billion for Corning glass production and presented the president with a gold-plated plaque—gestures Bloomberg Intelligence analysts said could “soften the White House’s ire” over Apple’s reliance on India for iPhone assembly.
Masimo on Wednesday also asked the court for a temporary restraining order and preliminary injunction to block enforcement of CBP’s Aug. 1 ruling. The company wants to restore the January decision, reached after a proceeding in which both Apple and Masimo participated, that allowed imports only if the oxygen-tracking function was disabled.
“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 U.S. marketplace,” Masimo said in its supporting brief.
Masimo said the reversal “effectively nullified” an October 2023 limited exclusion order from the ITC, which found Apple Watches infringe US Patent Nos. 10,912,502 and 10,945,648 covering non-invasive pulse oximetry. Apple’s appeal of the ban is pending at the Federal Circuit.
The company called CBP’s ex parte decision “an extraordinary departure” from its mandate and a violation of its own policy requiring adversarial proceedings absent “exceptional circumstances.”
CBP didn’t immediately provide comment on the allegations.
Quinn Emanuel Urquhart & Sullivan LLP represents Masimo.
The case is Masimo Corp. v. US Customs and Border Protection, D.D.C., No. 25-cv-2749, complaint filed 8/20/25.
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