# Major Recall Alert: Device Intended for the Subcutaneous Delivery of Insulin Recalled Due to Manufacturing Issue That Could Result in Under-Delivery
Individuals relying on Omnipod devices for insulin management: a crucial recall has been issued by Insulet Corporation. A manufacturing issue affecting certain lots of Omnipod® Pods could lead to insulin under-delivery, posing significant health risks for users. Here’s everything you need to know to stay safe and protect your health.
## Why This Recall is Important
For patients managing diabetes, accurate insulin delivery is a critical factor in maintaining stable blood glucose levels. Unfortunately, Insulet Corporation, the manufacturer of Omnipod devices, has identified a defect in specific lots of their Omnipod 5, Omnipod DASH®, and Omnipod® Insulin Management System (Omnipod Eros) Pods.
The defect, identified through routine product monitoring, involves the potential for small tears in the tubing (cannula) of affected Pods. These tears may prevent proper insulin delivery, which can lead to high blood glucose levels or, in severe cases, diabetic ketoacidosis (DKA). With approximately 24 reported serious adverse events, including hospitalizations due to high blood glucose levels, it’s vital that users address this issue immediately.
## Details of the Recall
The voluntary medical device correction announced by Insulet is targeting affected lots that were distributed in the U.S. and some international markets. Key details include:
- **Issue:** Manufacturing defect causing potential tears in the cannula, leading to insulin leakage.
- **Risk:** High blood glucose levels or DKA in cases of under-delivery.
- **Affected Products:** Specific lots of Omnipod 5, Omnipod DASH®, and Omnipod® (Eros) Pods.
- **Number of Pods Impacted:** Approximately 7 million, with 60% already consumed or expired.
- **Serious Cases Reported:** 24 incidents involving high blood sugar levels and hospitalization. No deaths have been reported.
- **Impact on CGM Systems:** Continuous glucose monitoring (CGM) systems or readings are not affected.
Affected users may spot evidence of the defect through wetness on the pod’s adhesive or a noticeable smell of insulin. However, in some cases, the damage may be undetectable, further increasing the risk of insulin under-delivery.
To prevent recurrence, Insulet has implemented corrective measures at their manufacturing facilities and strengthened product monitoring.
### Official Statement
According to Insulet’s official communication, they have sufficient stock to supply replacement Pods and do not anticipate disruption to product availability. The U.S. FDA has been notified of the recall. For more information, visit the FDA’s Recall Alert [here](https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/insulet-initiates-voluntary-medical-device-correction-certain-omnipodr-pods-us-and-affected).
## What You Should Do
If you’re using an Omnipod device, follow these steps to ensure your safety:
- **Identify Impacted Pods:** Check if your Pod lot number is among those affected by visiting the official [Check Pod Lot](https://www.omnipod.com/current-podders) page.
- **Stop Using Affected Devices:** If a Pod from an affected lot is in use, discontinue use immediately and switch to an unaffected Pod.
- **Request Replacement Pods:** Obtain replacement Pods at no cost from Insulet.
- **Contact Customer Support:** For U.S. users, call Insulet Product Support at 1-800-641-2049, available 24/7, or use the live chat feature at their [website](https://www.omnipod.com/current-podders). International users can visit [omnipod.com](https://www.omnipod.com) for more details.
## Stay Safe – Get Instant Recall Alerts
Managing your health shouldn’t be a guessing game. Ensure safety by staying informed about product recalls and device corrections that could impact your daily routine. Download a reliable recall alert app today to receive instant updates on medical device warnings, safety corrections, and other critical announcements.
Staying informed is your first defense against potential risks. Protect your health or that of a loved one by taking action now. Visit the Omnipod product safety page and follow the instructions to secure your replacements.