Insulet Corporation recalls
15 recalls in our records from 2013 to 2026: 15 FDA medical devices.
Recalls with full detail pages
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Insulet Corporation medical device recall: Omnipod 5 Pods. Includes the below Model/REF Numbers: 1.…
External soft cannula damage during manufacturing that results in insulin leaking around the Pod instead of being delivered to the user regardless of basal or bolus…
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Insulet Corporation medical device recall: Omnipod 5 Pods. Model/Catalog number: PT-001662 ASM 5PK Pod STRL OPS…
Due to a manufacturing defect, certain Omnipod 5 Pods from 49 lots have an internal soft cannula tear that results in insulin leaking into the Pod instead of being…
Earlier and other recalls
These link to the official agency notice.
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Insulet Corporation medical device recall: The failure occurs if a user on the Omnipod 5 iOS application selects… Official notice ↗
The failure occurs if a user on the Omnipod 5 iOS application selects and holds down on a manual entry field, to magnify the visual field using the magnifying feature of…
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Insulet Corporation medical device recall: Omnipod 5 Automated Insulin Delivery System Official notice ↗
Insulet Corporation is recalling Omnipod 5 iOS App, due to a software design issue in which a comma is not recognized as a decimal separator and the user cannot enter a…
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Insulet Corporation medical device recall: Omnipod 5 App Official notice ↗
The bolus calculator is not recording the decimal point if it is the first value entered when changing a bolus dose. This may lead to an over-delivery of insulin to the…
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Insulet Corporation medical device recall: Omnipod 5 Automated Insulin Delivery System Official notice ↗
An error message was received when using the Omnipod 5 App on compatible smartphones that prevented phone control users from controlling the Omnipod 5 Automated Insulin…
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Insulet Corporation medical device recall: Omnipod 5 Automated Insulin Delivery System Product catalog numbers:… Official notice ↗
The firm has become aware of an issue with the Omnipod 5 Controller where the Controller charging port and charging cable are melting, deforming, or discoloring due to…
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Insulet Corporation medical device recall: 18239: ASM Omnipod Dash PDM Official notice ↗
The firm has become aware of PDM battery issues, including battery swelling, fluid leaking from the battery, and extreme overheating, which may pose a fire hazard. The…
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Insulet Corporation medical device recall: Omnipod DASH Insulin Management System User Guide Official notice ↗
Certain foreign user guides include a misprint which could lead to an incorrect bolus delivery and hypoglycemia. Only Outside the US (OUS): Error in the Omnipod DASH…
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Insulet Corporation medical device recall: Omnipod DASH Insulin Management System Official notice ↗
After the device has been in use for about 2 months, data processing in the PDM can be slowed such that the Bolus Calculator fails to accurately subtract the correct…
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Insulet Corporation medical device recall: Omnipod DASH Personal Diabetes Manager Official notice ↗
In certain scenarios, the Omnipod DASH PDM may suggest an inaccurate bolus amount based on a blood glucose value that is more than 10 minutes old when the user does not…
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Insulet Corporation medical device recall: Omnipod DASH Insulin Management System Official notice ↗
There is a potential for a communication interruption following a bolus command that may result in inaccurate information presented in insulin on board (IOB), last bolus…
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Insulet Corporation medical device recall: OmniPod¿ Official notice ↗
Pod's needle mechanism fails to deploy or there is a delay in the deployment of the needle mechanism.
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Insulet Corporation medical device recall: OmniPod¿ Insulin Management System. Only the OmniPod¿ device is… Official notice ↗
OmniPods¿ (Pods) have a higher rate of failure causing: Cannula fails to deploy/retract causing insulin to be pumped or the audible alarm is displayed on the PDM and pod…
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Insulet Corporation medical device recall: OmniPod Insulin Management System Starter Kit Official notice ↗
Alcohol Prep Pads contained within the kit are not properly labeled.
Firm names are matched across agencies by name only. Different companies with similar names may be grouped together; check each official notice.