Insulet Recalls OmniPod Insulin Devices Due to Deployment Failures
Insulet Corporation is recalling specific OmniPod insulin devices because they may fail to deploy or retract the cannula, potentially disrupting insulin delivery.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source text explicitly identifies the recall as FDA Class I, which mandates a severity score of at least 4 per the rubric, as Class I recalls involve a reasonable probability of serious adverse health consequences or death.
Plain-English summary
Insulet Corporation is recalling the OmniPod Insulin Management System, specifically the OmniPod device, due to a higher rate of failure. The affected devices are intended for the subcutaneous delivery of insulin for the management of diabetes mellitus.
The recall involves 16,017 boxes, with an expanded recall of 5,179.0 boxes. The affected lot numbers are L40771, L40892, L40901, L40905, L40997, L41199, and L41208. The expanded recall includes lot codes L41908, L41910, and F41935. The product was distributed nationwide in the United States and in Switzerland.
The identified issue is that the cannula may fail to deploy or retract. This failure can cause insulin to be pumped incorrectly or result in the pod failing to deliver insulin, with an audible alarm displayed on the Personal Diabetes Manager (PDM). Consumers should check their devices against the listed lot numbers and contact Insulet Corporation for further instructions.
The recalled product
- Product
- OmniPod¿ Insulin Management System. Only the OmniPod¿ device is affected. Catalog Number(s): 14810 (OUS). 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 (9)
- Lot Numbers: L40771
- L40892
- L40901
- L40905
- L40997
- L41199
- L41208 Expanded Recall: Lot Codes: L41908
- L41910
- F41935
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.
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