This is not a full product recall. On May 26, 2026, Insulet issued a voluntary correction; however, it is separate from an earlier March 2026 correction involving certain Omnipod 5 lots.
According to the FDA, corrections and recalls play a critical role in protecting public health and ensuring medical devices perform as intended.
What You Need to Know
- Approximately 7 million Omnipod insulin pods are included in this voluntary medical device correction.
- The defect involves a small tear in the tubing, causing insulin to leak externally rather than being delivered into the body.
- This can result in under‑delivery of insulin, leading to dangerously high blood glucose levels or life‑threatening diabetic ketoacidosis (DKA)
Important Information for Omnipod Users
The issue: A tear in the tubing just above the skin can cause insulin to leak out of the body, preventing full insulin delivery.
Signs your pod may be affected:
- Wetness on the skin or pod adhesive
- The smell of insulin
- Unexplained high blood glucose levels
What You Need to Do
- Visit Check Pod Lot to confirm whether your Pod lot number is included in this voluntary Medical Device Correction. (Locate the lot number on the pod tray lid or on the pod itself. Enter the lot number on Insulet’s recall lookup page.)
- Stop using any defective pods immediately
- Request replacement Pods (Insulet will replace all affected pods at no cost). A full list of affected lots is available on this site.
For customers in the U.S. who have questions or need assistance, contact:
Insulet Product Support 📞 1‑800‑641‑2049 💬 Live chat: www.omnipod.com/current-podders
Details of the Omnipod Insulin Pod Correction (May 2026)
Roughly 7 million pods fall within the scope of this action, though about 60% have already been used or have expired.
The correction affects specific lots of:
- Omnipod® 5
- Omnipod DASH®
- Omnipod® Insulin Management System (Eros)
Insulet has identified the manufacturing cause and implemented corrective measures to prevent recurrence.
According to the FDA, 24 serious adverse events have been reported globally, including hospitalizations and cases of DKA. No deaths have been linked to this issue.
Pods not included in the affected lots remain safe to use.
Do You Have a Potential OmniPod Claim?
If you believe a recalled Insulet Omnipod caused you injury, speaking with an experienced product liability attorney is the best way to protect your rights.
The Nash & Franciskato Law Firm has extensive experience representing individuals harmed by defective medical devices. Our team has secured significant results against major manufacturers and understands the complexities of medical device litigation.
Medical device manufacturers have a responsibility to ensure their products are safe. When they fail, patients pay the price—and legal action may be the only way to hold them accountable.
Call (877) 284‑6600 or start your free, no-obligation case review below.
Sources
- Company Announcement: Insulet Initiates Voluntary Medical Device Correction for Certain Onmipod (R) Pods in the U.S. and Affected International Markets
- Recalls, Corrections, and Removals, U.S. Food & Drug Administration
- Urgent Medical Device Correction
Photo Credits:
- Romaset(Roman Zaiets) – Medical Device for Glucose Check. Continuous Glucose Monitor. – via www.depositphotos.com
- Kzenon(Arne Trautmann) – Image File – via www.depositphotos.com