Omnipod 5 Recall 2026: Insulin-Leak Hazard—Verify Your Lot Numbers Now
Insulet Corporation has issued a voluntary medical-device correction for certain lots of Omnipod 5 insulin-delivery pods sold in the United States. A manufacturing defect can cause insulin to leak inside the pod, leading to under-delivery and potentially serious hyperglycemia or diabetic ketoacidosis (DKA). Users should stop using affected pods, confirm lot numbers, and request free replacements right away.
Omnipod 5 Recall Overview
- Recall type: Voluntary Medical Device Correction (FDA-posted)
- Announcement date: March 12, 2026
- FDA publish date: March 13, 2026
- Brand: Omnipod 5 (Insulet Corporation)
- Product: Alternate-controller-enabled insulin-infusion pod
- Hazard: Internal tubing tear may leak insulin, causing under-delivery
- Reported events: 18 serious adverse events (hospitalizations & DKA); no deaths reported
Sources
Health Risks From Under-Delivery of Insulin
If the pod’s tubing tears, insulin can pool inside the device instead of entering the body. Insufficient delivery may lead to:
- Persistent high blood glucose (hyperglycemia)
- Nausea, vomiting, or dehydration
- Diabetic ketoacidosis (DKA), a life-threatening emergency
How to Check Whether Your Omnipod 5 Pods Are Affected
Only specific lots are included in this correction. Follow these steps:
- Find the lot number on each pod box or on the foil pouch.
- Go to omnipod.com/check-pods.
- Enter the lot number to confirm status and request free replacements if needed.
Do not use pods from an affected lot. Replace them immediately with an unaffected pod.
Steps Omnipod 5 Users Should Take Now
- Stop using any affected Omnipod 5 pod currently in service.
- Switch to an unaffected pod or another insulin-delivery method.
- Monitor blood glucose closely until replacement pods arrive.
- Dispose of defective pods according to local sharps regulations.
Omnipod 5 Customer-Support Contacts
Insulet Product Support is available 24/7 at 1-800-641-2049 or via live chat at omnipod.com/current-podders.
Frequently Asked Questions
1. Why were Omnipod 5 pods recalled?
The recall was issued because some Omnipod 5 pods have a tiny tear in internal tubing that can leak insulin, causing under-delivery and potentially dangerous hyperglycemia or DKA.
2. Does the Omnipod 5 recall affect my continuous glucose monitor (CGM)?
No. The tubing defect is confined to select Omnipod 5 pods and does not interfere with any CGM devices or readings.
3. How can I confirm whether my Omnipod 5 lot number is included?
Locate the lot number on your pod packaging and enter it at omnipod.com/check-pods to verify recall status.
4. Will Insulet replace my affected Omnipod 5 pods for free?
Yes. Once your lot is validated as affected, complete the online form to receive replacement Omnipod 5 pods at no cost.
5. I’m already experiencing high blood glucose with an Omnipod 5 pod—what should I do?
Immediately switch to an unaffected Omnipod 5 pod or a backup insulin-delivery method and follow your healthcare provider’s guidance. Seek urgent care if you suspect DKA.
6. Is insulin leakage from an Omnipod 5 pod visible?
Not always. Leaks may be internal and invisible, which is why any pod from a recalled Omnipod 5 lot should be replaced even if no liquid is seen.
7. Will the Omnipod 5 recall delay my future pharmacy shipments?
Insulet states that unaffected Omnipod 5 inventory is available. Once your replacement request is processed, shipments should resume on a normal schedule.