
Medical device maker Masimo has filed a lawsuit against US Customs and Border Protection (CBP), accusing the agency of improperly allowing Apple to resume importing Apple Watches with blood-oxygen monitoring technology.
The legal challenge comes as Masimo continues its broader fight with Apple over patents tied to pulse oximetry.
Masimo's complaint, filed Wednesday in Washington, DC federal court, argues that Customs quietly reversed a previous ruling that had blocked Apple's watches from including the feature.
According to the filing, CBP issued a decision on August 1 permitting Apple to bring in models with blood-oxygen capability, despite an earlier ban issued by the US International Trade Commission (ITC).
The company said it only learned of the change after Apple announced on August 14 that the blood-oxygen function would return to its devices through a software update.
"CBP's function is to enforce ITC exclusion orders, not to create loopholes that render them ineffective," Masimo stated in its court filing.
The long-running dispute began in December 2023, when the ITC ruled that Apple had infringed Masimo's patents involving pulse oximetry technology.
According to WCCF Tech, that decision temporarily blocked sales of the Apple Watch Series 9 and Apple Watch Ultra 2 in the United States.
Masimo sues US Customs over Apple Watch blood oxygen workaroundhttps://t.co/GnrNIrH68m
— 9to5Mac (@9to5mac) August 20, 2025
Masimo Challenges Customs' Approval of Apple Watch Workaround
Apple responded by disabling the blood-oxygen feature through software updates, allowing sales to continue without violating the order.
However, earlier this month, Apple confirmed it would restore the feature by pairing the watches with iPhones, a move it said had been approved by Customs.
Masimo argues that the agency overstepped its authority and failed to give the company notice or a chance to respond before issuing its new ruling.
Masimo, based in Irvine, California, has also accused Apple of hiring away key staff and misusing its trade secrets in separate ongoing lawsuits, Reuters said.
The company says each day the Customs decision remains in place causes "irreparable harm" to its competitive position in the US market.
In its latest filing, Masimo is asking the court for a temporary restraining order and a preliminary injunction that would reinstate the ITC's original import ban.
The company maintains that CBP's August 1 decision was made without meaningful justification and effectively nullifies the ITC's exclusion order.
Apple and Customs have not yet commented on the lawsuit.
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