Omnipod 5 recall alert
Insulet has recalled some Omnipod 5 insulin pods after reports of dangerous internal tubing tears that caused insulin leakage—18 serious adverse events with uncontrolled hyperglycaemia have been logged so far [] []. Users should check lot numbers and contact clinicians immediately if delivery failures occur.
Insulet initiated a voluntary Medical Device Correction on March 12, 2026. investors.insulet.com The U.S. Food and Drug Administration posted the company announcement to its recall database on March 13, 2026. fda.gov Insulet said the Pods involved represent roughly 1.5% of annual Omnipod® 5 pod production globally. investors.insulet.com The company said the action applies only to specific identified lots distributed in the United States. omnipod.com Recalled lot numbers have been reported in media as beginning with the prefix "PH1U" followed by an eight‑digit code, though Insulet has not published a public list and directs users to verify individual lot numbers online. everydayhealth.com The lot identifier is printed on the pod tray lid, the bottom of the pod and the five‑pack box. everydayhealth.com Insulet is offering replacement Pods at no cost and directs customers to its "Check Your Pod" tool or live chat, or to call Product Support at 800‑641‑2049 (24/7) to request replacements and return unused affected Pods. investors.insulet.com The company also reported changes to manufacturing controls and said it does not anticipate disruption to customer shipments or new patient starts. investors.insulet.com
