Insulet Recalls Omnipod DASH Insulin Systems Due to Communication Interruption
Insulet Corporation is recalling 264 units of the Omnipod DASH Insulin Management System because a communication interruption may cause inaccurate insulin data to be displayed.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a high-risk medical device where a defect could lead to inaccurate insulin dosing information, representing a risk of harm even though no injuries have been reported.
Plain-English summary
Insulet Corporation is recalling 264 units of the Omnipod DASH Insulin Management System, Product Catalog Number 18239. The affected units are distributed nationwide in the United States and include specific lot numbers ranging from L000120 to L000136.
The recall was initiated because there is a potential for a communication interruption following a bolus command. This technical issue may result in inaccurate information being presented in the insulin on board (IOB), last bolus field, or bolus history. The source text does not report any illnesses or injuries associated with this defect.
Consumers should check their device's lot number against the list provided by the manufacturer. If the device is affected, users should contact Insulet Corporation for further instructions on how to proceed.
The recalled product
- Product
- Omnipod DASH Insulin Management System, Product Catalog Number 18239 M/D: PDM USA1 D001 MG USA1
- Manufacturer
- Insulet Corporation
- Affected units
- 264
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 (10)
- Lot Numbers L000120
- L000121
- L000122
- L000123
- L000124
- L000131
- L000132
- L000133
- L000135
- L000136
Distribution
Distributed nationwide across the United States.
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