Omnipod Insulin Pod Recall 2026: FDA Warns of Under-Delivery Risk
Insulet Corporation has issued a voluntary recall for select lots of Omnipod 5, Omnipod DASH, and Omnipod Eros insulin delivery pods after a manufacturing defect was linked to insulin under-delivery. A microscopic tear in the cannula can let insulin leak onto the skin instead of flowing under it. Users could receive too little insulin and develop severe hyperglycaemia or diabetic ketoacidosis (DKA). Stop using any affected lots, verify your pods, and request free replacements immediately.
Quick Recall Facts for Omnipod Users
- Recall type: Voluntary Medical Device Correction
- Date announced: 26 May 2026 (FDA posting same day)
- Affected products: Omnipod 5, Omnipod DASH, Omnipod Eros insulin pods
- Defect: Cannula tear may cause insulin to leak and under-deliver
- Scale: About 7 million pods (≈ 8.5 % of 2025 global output)
- Serious events: 24 reports of extreme hyperglycaemia/DKA; no fatalities
How to Check If Your Omnipod Pods Are Recalled
Insulet maintains a searchable database of affected lot numbers. Follow these steps:
- Find the lot number on the outer box, individual pod blister, or the paper insert.
- Open the official Check Pod Lot tool and enter the number.
- If listed, cease using that lot and follow the replacement process below.
What Omnipod Users Should Do Right Now
- Immediately swap any in-use pod from an affected lot with an unaffected one.
- Monitor blood glucose frequently; seek medical help for sustained high readings or DKA symptoms (thirst, nausea, rapid breathing).
- Request complimentary replacement pods through the Check Pod Lot tool or by calling Insulet Product Support (1-800-641-2049, 24/7).
- Outside the U.S., select your region via the banner at omnipod.com.
What Causes the Omnipod Cannula Tear Issue?
Routine quality testing found that a small fraction of pods have a hairline tear in the cannula tubing at skin level. When this happens, insulin can seep onto the adhesive pad instead of being delivered subcutaneously. Warning signs include:
- Moisture under or around the pod
- Noticeable insulin smell
- Unexplained high blood glucose
The leak may be subtle, so users may only realise there is a problem once glucose levels rise.
How to Get Free Omnipod Pod Replacements
Insulet has confirmed it can replace every affected pod at no charge:
- U.S. customers: Phone 1-800-641-2049 or use live chat at omnipod.com/current-podders.
- International customers: Go to omnipod.com and follow the country-specific banner instructions.
FDA & Global Oversight of the Omnipod Recall
The U.S. Food and Drug Administration (FDA) and other international regulators have been notified. Full details are posted on the FDA recall database (see Sources below).
Sources
Frequently Asked Questions About the Omnipod Recall
1. Which Omnipod products are affected by the recall?
Only specific lots of Omnipod 5, Omnipod DASH, and Omnipod Eros pods manufactured in 2025 are affected. The PDM, Omnipod 5 Controller, and any continuous glucose monitor you use are not recalled.
2. How do I locate my Omnipod lot number?
The lot number is printed on the outer carton, each individual pod blister pack, and the paper instructions. Compare it with the online database.
3. Is it safe to keep using unaffected Omnipod lots?
Yes. Insulet confirms pods not listed in the recall remain safe when used as directed.
4. What signs show my Omnipod pod is leaking insulin?
Look for dampness under the adhesive, a strong insulin odour, or unexplained high blood glucose readings.
5. Will I have to pay anything for Omnipod replacement pods?
No. Insulet is shipping replacements for verified affected lots at no cost, including delivery.
6. Can I continue using recalled Omnipod pods until my replacements arrive?
No. Switch to an unaffected lot immediately to avoid the risk of under-delivery and DKA.
7. Does the Omnipod recall affect my Omnipod 5 Controller or DASH PDM?
No. The recall is limited to insulin pods. All controllers, PDMs, and software are unaffected.