The litigation centers on the performance and safety of the company’s flagship products, including the Omnipod 5 and Omnipod Dash systems. According to the complaint, Insulet failed to disclose significant vulnerabilities in its manufacturing procedures, creating a heightened risk of regulatory violations and potential injury. These omissions surfaced in two distinct waves of voluntary medical device corrections.

On March 12, 2026, the company announced the first correction for specific lots of Omnipod 5 Pods, causing the stock price to drop 6.88%. A second, broader correction followed on May 26, 2026, involving the Omnipod 5, Omnipod Dash, and the legacy Omnipod Insulin Management System. The company cited manufacturing issues capable of causing insulin under-delivery, triggering a further 5.07% decline in share value. Investors seeking to serve as lead plaintiff have until August 31, 2026, to petition the court.