Omnipod 5 and Omnipod DASH recall

Products affected:

Omnipod® 5 Automated Insulin Delivery System 
(20385083000548, 10385083000527)

Omnipod DASH® Insulin Management System 
(20385082000020, 10385082000023)

Pods not included in the affected lots remain safe to use. Therapeutic Goods Administration (TGA) have been notified of this action. 

What the problem is

Some Pods from specific lots may have a small tear in the tubing (cannula) just above the skin, between the Pod and the point where the cannula enters the body.  

If this occurs, insulin may leak outside of the Pod instead of being fully delivered into the body as intended, potentially leading to under-delivery of insulin. If you are using an affected Pod, you may notice wetness on your skin or Pod adhesive or detect the smell of insulin. However, in some cases, this may be difficult to detect and may go unnoticed. 

If insulin leakage occurs, your blood glucose levels may rise and may not respond as expected to insulin delivery. 

Do not rely only on Pod alerts to know if something is wrong. 

Note that this problem does not affect continuous glucose monitoring (CGM) systems or CGM readings.

Potential risks

If insulin is not delivered properly, you may experience high blood glucose levels. In the most severe cases, prolonged and persistent high blood glucose levels can lead to diabetic ketoacidosis (DKA), a serious medical condition that requires prompt medical treatment and can be life-threatening if not treated. 

What you need to do

If you are using Omnipod® 5 or Omnipod DASH®, please take the following steps immediately:

1. Check the lot number on your Pod tray lid, the Pod box or the Pod itself to determine if your Pods are affected (see below for more details about where to find the lot number).
   
   All Pods within the box will be from a single lot. If the lot is affected, do not use any of those Pods. 
   
   
2. If your Pods are impacted:
   
   • Discontinue use straight away. If the Pod you are currently using is from an affected lot, it is important that you immediately change your Pod to resume insulin delivery. When changing your Pod, confirm that the new Pod is not from an affected lot.  
     
     
   • You will have received an email with subject line: ACTION REQUIRED: Review and Acknowledge Recall for Omnipod Pods. Open this email and click “Acknowledge & Check Lots” to acknowledge that your Pod is impacted and request a replacement.
3. If your Pods are not impacted:  
   • Find the email with subject line: ACTION REQUIRED: Review and Acknowledge Recall for Omnipod Pods and click “Acknowledge & Check Lots” to acknowledge that your Pods are not impacted.
     
     
4. For additional support, please call the Insulet Product Support phone line at 1800 954 074, available 24/7.

You will receive a return kit with clear instructions on how to send back any unused affected Pods. 

If your Pod supply is depleted due to this problem, consult with your healthcare provider for alternative means of insulin delivery while waiting for Pods to be replaced. Always follow your healthcare provider's guidance on appropriate glucose monitoring. 

For more support: Please visit Frequently Asked Questions or call 1800 954 074, available 24/7. 

Where to find the lot number

The lot number can be located on the Pod tray lid, the 10 pack Pod box, and the flat side of the Pod.

Pod lot number location on the Pod tray lid (circled below in red):

Pod lot number location on the side of the 10-pack Pod box (note all Pods in the same box will have the same Pod lot number): 

Pod lot number location on the Pod itself (flat side):

Affected lots:
Omnipod DASH

PD1U09042421 
PD1U11122421 
PD1U11202421

Omnipod 5

PH1U10212421