The FDA has officially classified Insulet's recall of certain Omnipod insulin delivery pods as a Class I recall — the agency's most serious label. That means using the affected devices could lead to serious injury or even death.

The problem? Some pods may not deliver the full dose of insulin they're supposed to. Instead, a small tear in the cannula tubing — the part that sits just under the skin — can cause insulin to leak out of the body. That can leave users with dangerously high blood sugar, and in severe cases, lead to diabetic ketoacidosis (DKA), a life-threatening condition.

Omnipod devices are wearable insulin pumps that deliver insulin subcutaneously at programmed rates for people with diabetes who need insulin therapy. The recall covers three product lines: the Omnipod 5 Automated Insulin Delivery System, the Omnipod DASH Insulin Management System, and the Omnipod Insulin Management System (also called Omnipod Eros).

The FDA said Thursday that the recall involves removing specific pods from where they are used or sold. Insulet is asking customers not to use pods from affected lots and to check the lot number printed on the pod tray lid, box, or the pod itself. If you're currently wearing an affected pod, the FDA recommends swapping it out immediately for one from an unaffected lot to restore proper insulin delivery.

If you've already used up your supply because of the recall, don't panic — but do call your healthcare provider to figure out an alternative insulin delivery method while you wait for replacements.

How do you know if your pod is leaking? You might notice wetness around the pod or smell insulin. But the leak can also go undetected, which is part of what makes this recall so tricky. Even users of the Omnipod 5 system in automated mode shouldn't rely solely on device alerts, the FDA warned, because the issue may not trigger a warning.

The good news: this problem doesn't affect continuous glucose monitoring (CGM) readings, so your CGM data should still be accurate. But if your blood sugar is running higher than expected and not responding to insulin, it could be a sign your pod is leaking.

As of May 20, Insulet had reported 24 serious injuries tied to the issue. No deaths have been reported so far.

Insulet shares were down 3.30% at $159.05 at the time of publication on Monday, according to market data.