Medical device manufacturer Insulet Corporation announced Tuesday it is conducting a voluntary recall of specific insulin pump pods following the discovery of a manufacturing defect that may prevent patients from receiving adequate insulin doses.
The company’s stock price dropped 8% during after-hours trading following the announcement.
Key details of the recall include:
• The recall impacts particular batches of Omnipod 5, Omnipod DASH and the Omnipod Insulin Management System that were distributed throughout the United States and certain international markets.
• The defect, discovered during standard quality monitoring procedures, can create a small rupture in the cannula tubing above the patient’s skin, which may cause insulin to leak out rather than being properly administered.
• Patients might observe moisture or detect the odor of insulin, although the malfunction could potentially remain unnoticed.
• Insufficient insulin delivery can result in elevated blood glucose levels and, in extreme situations, diabetic ketoacidosis, a potentially fatal complication.
• This recall is distinct from a previous correction in March 2026 and stems from a separate manufacturing procedure, although both issues involved cannula processing at the company’s Massachusetts manufacturing plant, according to Insulet’s regulatory submission.
• Approximately 7 million pods are covered by this current recall, with roughly 60% already consumed or past their expiration date, accounting for about 8.5% of worldwide pod manufacturing in 2025, the company stated.
• Insulet documented 24 serious adverse reactions, including hospital admissions, but reported no fatalities.
• The company anticipates no interruptions to product supply and estimates related expenses could reach $50 million this year.
