Insulet Recalls OmniPod Insulin Devices Due to Cannula Deployment Failures
Insulet Corporation is recalling specific OmniPod insulin devices because the cannula may fail to deploy or retract, potentially interrupting insulin delivery.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class I, which is the most serious classification for medical devices, indicating a reasonable probability that use of the product will cause serious adverse health consequences or death. The failure of an insulin delivery device poses a significant risk to patients with diabetes.
Plain-English summary
Insulet Corporation is recalling the OmniPod Insulin Management System, specifically the OmniPod device (Catalog Number POD-ZXP420), due to a higher rate of failure. The device is intended for the subcutaneous delivery of insulin for the management of diabetes mellitus.
The recall is being conducted because the cannula may fail to deploy or retract. This failure can cause insulin to be pumped when it should not be, or the pod may fail to deliver insulin entirely, displaying an audible alarm on the Personal Diabetes Manager (PDM). The recall covers approximately 24,829 boxes (expanded to 26,230.9 boxes) distributed nationwide in the United States and in Switzerland.
Consumers who have the affected OmniPod devices should stop using them and contact Insulet Corporation for instructions on how to return the product or obtain a replacement. The specific lot numbers affected are listed in the official recall documentation.
The recalled product
- Product
- OmniPod¿ Insulin Management System. Only the OmniPod¿ device is affected. Catalog Number(s): POD-ZXP420 (US). Intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin.
- Manufacturer
- Insulet Corporation
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Lot Numbers: L40806
- L40811
- L40895
- L40976
- L41014
- L41025
- L41067
- L41162
- L41171
- L41197
- L41198
- L41250 Expanded Recall: Lot Codes: L41880
- L41881
- L41892
- L41895
- L41897
- L41898
- L41899
- L41900
- L41901
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Insulet Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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