November 17, 2022

FDA: Class I recall of Insulet Omnipod DASH PDM

By: Judy Mathias

Editor's Note

The Food and Drug Administration (FDA) on November 16 identified the recall by Insulet of its Omnipod DASH Insulin Management System Personal Diabetes Manager (PDM) as Class I, the most serious.

The recall was initiated because of PDM battery issues, including:

  • Battery swelling
  • Fluid leakage from the battery
  • Extreme overheating that may pose a fire hazard.

The company reports 455 complaints, three fires, and no injuries or deaths.

Distribution dates were July 27, 2018, to August 31, 2022.

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