Millions of Insulin Pods May Be Leaking, FDA Warns: Here's How to Check Yours
Insulet is replacing affected pods for free after 24 serious adverse events and reports of high blood glucose, the FDA said.
- On Tuesday, May 26, the FDA and Insulet Corporation announced a voluntary Medical Device Correction for approximately 7 million Omnipod insulin pods due to a manufacturing error causing potential insulin under-delivery.
- Specific lots of Omnipod 5, Omnipod DASH, and Omnipod Insulin Management System pods contain a small tear in the tubing, impacting roughly 8.5% of 2025 global production.
- Globally, there have been 24 reports of "serious adverse events" associated with high blood glucose levels, including hospitalization and DKA; users may notice wetness on their skin or the smell of insulin.
- Insulet Product Support is contacting affected customers to offer free replacements for defective units, while consumers should stop using the pods immediately and verify their lot numbers online.
- These products were distributed to at least 22 countries, though Insulet stated that an estimated 60% of impacted pods have already expired or been used, and the correction does not impact CGM readings.
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Millions of insulin pods may be leaking, FDA warns: Here's how to check yours
Millions of Onmipod insulin pods can possibly under-deliver medicine. Here's what to know about the issue that lead to the global correction. (Adobe Stock)
Insulet flags dosing defect in some Omnipod devices, sees up to $50 million cost
Insulet said on Tuesday it is carrying out a voluntary correction of certain insulin pump pods across its Omnipod product lines after identifying a manufacturing issue that could result in patients receiving too little insulin.
Insulet initiates another Omnipod 5 recall, affects Dash, Eros too
The Omnipod 5 worn on the arm. [Image courtesy of Insulet]Insulet (Nasdaq:PODD) today announced a voluntary medical device correction for specific lots of its Omnipod 5, Dash and Eros pods. The company identified a manufacturing issue through ongoing product monitoring that could result in insulin under-delivery with the affected current-generation Omnipod 5, previous-generation Omnipod Dash or the prior Omnipod Insulin Management System (Eros).…
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