- Insulet Corporation, Inc. recalled millions of Omnipod insulin pumps, according to the U.S. Food & Drug Administration.
- The pumps were recalled over a potentially dangerous manufacturing issue.
- Here’s where to find a list of impacted products.
If you have type 1 diabetes, you probably rely on an insulin pump to regulate your symptoms. But if you use an Omnipod pump, you should double-check that you’re getting the insulin you need—and consider trading your device in for another—as millions of the devices are being recalled nationwide.
According to the U.S. Food & Drug Administration’s announcement, the recall was initiated by Insulet Corporation, Inc. due to a potentially hazardous manufacturing issue. A “small tear” in the pump’s tubing could cause insulin to “leak outside of the Pod [sic] instead of being fully delivered into the body as intended, potentially leading to under-delivery of insulin,” per the FDA.
While this issue doesn’t affect the functionality of the device’s continuous glucose monitoring (CGM) and reading features, it’s still serious. The under-delivery of insulin could result in high blood sugar levels, which, if left untreated, could lead to life-threatening diabetic ketoacidosis (DKA). As of publishing, there have already been 24 reported “serious adverse events” resulting from use of the recalled pods, including some hospitalizations and instances of DKA. No deaths have been reported.
Here’s everything you need to know about the recall.
Which products are impacted by the recall?
Approximately seven million Omnipod 5 Pods, which were distributed nationwide, are included in the recall. About 60% of the recalled pods are estimated to be expired or out of use.
Per the FDA, a noticeable smell of insulin, or a feeling of wetness on the skin or the pod’s adhesive, could signal that something’s wrong with your pump. But in many cases, the malfunction goes unnoticed, which means you’ll want to confirm whether your pump is included in one of the affected lots.
You can check if your pod is impacted by visiting Omnipod’s Check Pod Lot site and entering its lot number. The page also provides instructions for locating the lot number on your pod, and a full list of impacted lot numbers.
What should I do with a recalled product?
If your pod is from a recalled lot, stop using it immediately and replace it with one that isn’t impacted.
Per the FDA, Insulet will replace any affected pods at no cost. Customers can request replacement pods on the company’s Check Pod Lot page. Insulet customer support is also available to answer questions and can be reached at 1-800-641-2049 or via online chat.
If you’ve been using one of the affected pods and are experiencing any health concerns, be sure to contact your doctor right away.
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