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FDA: Insulet Omnipod DASH Recall Deemed Class I

18 Nov 2022

Batteries used in the diabetes management devices may leak fluids or overheat, posing a potential fire risk. The recall, which the US FDA has now announced qualifies as high-risk class I, was first announced in October.

FDA (Food and Drug Administration) sign at its headquarters in Washington — • Source: JHVEPhoto / Shutterstock.com

Insulet’s recall of its Omnipod DASH personal diabetes manager (PDM) has been labeled class I by the US Food and Drug Administration, the most serious level. Class I recalls are reserved for devices that may cause serious injury or even death if used.

The recall, which is related to battery issues, was first announced on 17 October. It includes almost 250,000 devices distributed...