The FDA has classified a Class I recall, the most serious type, for the Omnipod 5. A few weeks ago, Insulet issued a voluntary medical device correction for the system, and this recall escalates that concern.

The recall affects certain lot numbers of the Omnipod 5, with some pods found to have a small tear in the internal tubing that delivers insulin. Rather than entering the body, insulin leaks inside the pod itself, leading to under-delivery. That under-delivery can cause high blood sugar and, in some cases, diabetic ketoacidosis (DKA). As of April 17, Insulet has reported 29 serious injuries and no deaths associated with this issue. It is worth noting that only users with affected lot numbers are impacted, and neither CGM systems nor CGM readings are affected.

The FDA is urging users to stop using any affected pods immediately. To check whether your pods are impacted, look up the lot number on the tray lid, box, or pod itself, then visit omnipod.com/check-pods to verify and request a replacement.

On the manufacturing side, Insulet says the issue has been corrected and does not expect any disruption to customer shipments, product availability, or new patient starts.

The Omnipod 5 is not the only pump facing a recall. Earlier this month, the FDA issued a Class I recall on the Tandem Mobi and a Class II recall on MiniMed insulin pumps, reminding pump users to stay alert for possible risks.