Insulet Recalls OmniPod Insulin Starter Kits Due to Mislabeling
Insulet Corporation is recalling 1,719 OmniPod Insulin Management System Starter Kits because the included alcohol prep pads are not properly labeled.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves a minor labeling error regarding alcohol prep pads, which fits the rubric criteria for moderate severity involving minor labeling issues.
Plain-English summary
Insulet Corporation is recalling 1,719 OmniPod Insulin Management System Starter Kits (Model Reference Number: SKT-UST400). The recall is due to a labeling error where the alcohol prep pads contained within the kits are not properly labeled.
The affected starter kits were distributed nationwide in the United States and in Israel. The specific lot numbers involved in this recall are L13483, L13485, L13478, and L13481.
Consumers who possess these starter kits should stop using the alcohol prep pads and contact Insulet Corporation for further instructions or a replacement.
The recalled product
- Product
- OmniPod Insulin Management System Starter Kit; Model Reference Number: SKT-UST400 (Starter Kit) Product Usage: The Starter Kit (SKT-UST400) is provided to users as an introduction to the OmniPod Insulin Management System prior to initiating care. It includes the Personal…
- Manufacturer
- Insulet Corporation
- Hazard
- Affected units
- 1,719
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 (4)
- Lot Numbers: L13483
- L13485
- L13478
- & L13481
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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