If you use this insulin pump, check the lot number immediately. A manufacturing defect has just been reported by the ANSM and the consequences could be serious.
Around 4.5 million people live with diabetes in France, some of whom use an insulin pump to regulate their daily blood sugar levels. The National Medicines Safety Agency (ANSM) published a safety alert on June 3, 2026 concerning several batches of insulin pumps distributed in France and around the world.
The problem is this. A small tear may appear in the small tube located just above the skin, between the pod and where insulin is injected into the body. The insulin then flows out of the device instead of entering the body. The person receives less insulin than expected without necessarily realizing it, but the consequences can be serious. Not enough insulin in the blood causes sugar levels to rise dangerously: what we call severe hyperglycemia. In the most severe cases, this can lead to diabetic ketoacidosis (DKA). It is “a serious condition requiring rapid medical attention and which may be life-threatening in the absence of treatment” recalls the manufacturer.
The insulin pumps concerned belong to the Omnipod range produced by the American company Insulet Corporation. The recalled lots are those of the Omnipod® 5, Omnipod DASH® and Omnipod® models. Around 60% of the devices concerned have already been used or have expired, but the risk exists for those still in circulation.
| Omnipod | Omnipod DASH | Omnipod 5 |
|
L71480 L72509 L72510 L72511 L72513 L72514 L72515 |
PD1U04262521 PD1U04292521 PD1U09032421 PD1U11112421 PD1U11132421 PD1U11142421 PD1U11152411 PD1U11152421 PD1U11162421 PD1U11182421 |
PH1U01072521 PH1U01242521 PH1U03082521 PH1U04172521 PH1U04182521 PH1U04212521 |
What to do if you are affected? First check the batch number written on the packaging or directly on the pod. If this number appears in the list of affected lots, no longer use the device and request a replacement. If you did not receive this letter and are using an Omnipod, talk to your pharmacist or doctor.
If you are using an Omnipod 5 in automated mode, the system may display an alarm on your screen if high sugar levels persist. But this alarm may also not appear. If in doubt, check your blood sugar immediately. And if you experience unusual symptoms – intense thirst, sudden fatigue, stomach aches or difficulty breathing – call 15 without delay. To this day, “A total of 24 reports of serious adverse events associated with hyperglycemia, including hospitalizations and cases of ADC, have been reported worldwide. No deaths have been reported.” specifies the manufacturer in a press release.
This alert does not concern other models of insulin pumps or injector pens. It is separate from a previous recall from March 2026, which only targeted certain Omnipod 5 pods in the United States for a different issue. For any questions, you can consult the dedicated page on the omnipod.com website.
