Insulet Recalls OmniPod Insulin Systems Due to Needle Deployment Failure
Insulet Corporation is recalling OmniPod Insulin Management Systems because the needle mechanism may fail to deploy or deploy with a delay.
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 agency classification is Class I, which per the rubric mandates a minimum score of 4 (Severe).
Plain-English summary
Insulet Corporation is recalling approximately 26,230.9 boxes of OmniPod Insulin Management Systems (Catalog Number: PODZXP420). The recall is due to a defect where the pod's needle mechanism fails to deploy or there is a delay in the deployment of the needle mechanism.
The affected products were distributed nationwide in the United States and in Switzerland, Germany, and Israel. The specific lot codes involved in this recall are L41880, L41881, L41892, L41895, L41897, L41898, L41899, L41900, L41901, L41902, L41903, L41904, L41905, L41906, and L41907.
The OmniPod Insulin Management System is intended for the subcutaneous delivery of insulin for the management of diabetes mellitus. Consumers should check their product lot codes against the list provided and contact Insulet Corporation for further instructions.
The recalled product
- Product
- OmniPod¿, Insulin Management System (US) Catalog Number: PODZXP420 Product Usage: The OmnniPod¿ Insulin Management System is intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin and for…
- 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 (15)
- Lot Codes: L41880
- L41881
- L41892
- L41895
- L41897
- L41898
- L41899
- L41900
- L41901
- L41902
- L41903
- L41904
- L41905
- L41906
- L41907
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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