Omnipod® Safety Notice: Insulet issues Urgent Field Safety Corrective Action Notice for certain Omnipod® Insulin Pumps

4 June 2026

Insulet is conducting a voluntary Field Safety Corrective Action for specific lots of Omnipod® 5 and Omnipod® Insulin Management System (Omnipod® Eros) Pods (tubeless insulin pump devices) due to a manufacturing issue identified through ongoing product monitoring. This action may affect some of your patients who use these products. Pods not included in the affected lots, remain safe to use.

Information for healthcare providers:

  • The issue is a small tear in the cannula tubing, causing insulin leakage and under-delivery of insulin.
  • Insulet is communicating directly with affected customers and providing clear instructions to help them identify affected lots, discontinue use of impacted Pods, and obtain replacement Pods at no cost.
  • If patients’ Pod supply is depleted due to this issue, Insulet are advising patients to contact their healthcare provider for guidance on alternative insulin delivery options until replacement Pods are received, and to always follow the guidance on appropriate glucose monitoring.

For assistance or questions, healthcare providers may contact their field sales representative or Insulet Product Support at 0800 011 6132 (+44 20 3887 1709) available 24/7.

Further information can be found here.

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