Insulet has recalled specific batches of its Omnipod 5 pods due to a manufacturing defect in the form of a small tear in the internal tubing that can cause insulin to leak inside the device instead of being fully delivered to the body.[1][3][4] This error leads to insufficient dosing of insulin, causing high blood sugar levels and, in the most severe cases, diabetic ketoacidosis (DKA).[1][4] The company had 18 reports of serious adverse events, including hospitalizations, but no deaths.[1][3][4] Affected pods account for approximately 1.5 percent of total annual production.[1][3][4] The problem does not affect continuous glucose monitoring (CGM) systems or their measurements.[3][4] Users can verify the batch number on the company's website and request a free replacement.[1][3] Insulet implemented changes in manufacturing processes to strengthen quality control.[4]