The US International Trade Commission (ITC), which handles international trade disputes, issued an order in October directing Apple to cease the import and sale of Apple Watches. This order was in response to a complaint filed by Masimo, a medical-monitoring technology company. The commission found that a specific feature on the Apple Watch, used for measuring blood-oxygen levels, violated Masimo's pulse oximetry patents. As such, the decision by the ITC applies solely to Apple Watches equipped with the specific light-based pulse oximetry feature under scrutiny. Although the administration of President Joe Biden had the option to veto the order within 60 days, they decided not to do so, citing public policy considerations, thereby enforcing the ban.

Masimo, a company that released a watch last year with blood-oxygen level monitoring and other health-tracking features, accused Apple of poaching its employees and stealing its technology after discussing a potential partnership. A jury trial in California federal court regarding these allegations resulted in a mistrial in May and is yet to be rescheduled. In response, Apple has filed a countersuit against Masimo in Delaware federal court, alleging patent infringement.

Apple plans to challenge the ban by appealing to the U.S. Court of Appeals for the Federal Circuit in Washington. Despite Apple's request to temporarily lift the ban during the appeal, the ITC rejected the motion on 20 December. In an effort to comply with Masimo's patents, Apple is reportedly developing software modifications to ensure its watches do not infringe upon the patents. If approved by U.S. Customs and Border Protection, Apple could resume importing and selling the watches. However, as per Masimo, its patents cover hardware, making a software solution insufficient. Masimo CEO Joe Kiani has further expressed a willingness to reach a settlement in the ongoing dispute.