Insulet has begun recalling specific lots of its Omnipod 5 insulin pumps in the U.S. after discovering a manufacturing defect that could cause them to leak insulin into the wearable device.
The diabetes tech company said it is aware of 18 cases of serious complications related to the under-delivery of insulin to the body, including hospitalizations linked to persistent high blood sugar levels as well as diabetic ketoacidosis.
Insulet said no deaths have been reported, and that it has notified the FDA of the issue.
Related
The company traced the problem to a small tear in the Omnipod’s internal tubing. It said the defect does not affect any connected continuous glucose monitoring systems or their readings.
Users can check to see if their pump is included by searching for the specific lot number on the company’s website. Affected customers should discontinue use and request a replacement at no cost.
Insulet said all other Omnipod products remain safe to use, and that the total number of defective pumps amounts to about 1.5% of its annual global production. The company said it will continue to manufacture and ship new Omnipod 5s without delays.
Related
Following its initial launch in the U.S. and Europe in 2022, the Omnipod 5 scored an FDA clearance in August 2024 as the agency’s first automated insulin pump for people with Type 2 diabetes. Currently, it is available in 19 countries and connects with CGMs from Dexcom and Abbott.
Insulet lists two “highly automated” manufacturing facilities in its latest annual report, located in Acton, Massachusetts and Johor, Malaysia. It is currently investing in a third plant in Costa Rica, and also works with a contract manufacturer in China to supply a significant portion of its inventory. In 2025, U.S. sales made up about 70% of the company’s revenue.