Insulet announced on Tuesday that it is voluntarily recalling approximately 7 million patch insulin pumps due to a manufacturing defect. The recall involves a potential issue with tiny tears in the tubing above the skin, which could cause insulin to leak out of the body, preventing users from receiving adequate medication. For people with diabetes, insufficient insulin can lead to serious hyperglycemia-related complications, such as diabetic ketoacidosis—a medical emergency caused by a severe lack of insulin.

Insulet stated in Tuesday's announcement that it has received 24 reports of serious adverse events, including hospitalizations and cases of diabetic ketoacidosis. The company has not received any reports of deaths related to this recall.

This correction involves specific batches of Insulet's Omnipod 5, Omnipod DASH, and earlier Omnipod insulin management systems. The affected devices account for 8.5% of the company's global production. Insulet stated that more than half of the affected devices may have already been used or expired. Users of affected products may notice a damp feeling on the skin or smell insulin, but the company also noted that the issue may be difficult to detect.

Insulet said in a filing with the U.S. Securities and Exchange Commission that it expects costs of up to $50 million this year due to this action. Leerink Partners analyst Mike Kratky noted in a research report that most of the expected expenses are related to product replacement and customer support. Insulet expects this correction will not affect its 2026 guidance, new customer acquisition, or churn rate.

Two recalls related to tears

In March of this year, Insulet recalled some Omnipod 5 devices due to a different tubing issue. At that time, the company stated that internal tubing tears could cause insulin to leak inside the pump. This event is separate from the current correction, affecting approximately 1.5% of Insulet's global Omnipod 5 production, and is expected to cost the company $40 million this year.

An Insulet spokesperson said via email that the latest recall involves a different tear location and different product batches.

The two issues stem from different manufacturing processes at Insulet's facility in Acton, Massachusetts. RBC Capital Markets analyst Shagun Singh noted in a research report that after the March recall, Insulet strengthened quality control measures to detect cannula tears, but the devices involved in the latest action were produced before these measures were implemented.

Leerink Partners' Kratky said Insulet reported that process improvements implemented due to the correction have been rolled out across the network, not just at the Acton facility.