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BioWorld - Tuesday, May 12, 2026
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Home » FDA announces two recalls of Medtronic insulin pumps
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FDA announces two recalls of Medtronic insulin pumps

Oct. 6, 2021
By Mark McCarty
The FDA reported two class I recalls associated with insulin pumps made by Dublin-based Medtronic plc, albeit for two significantly different issues. The two recalls affect roughly 495,000 units combined, and may significantly affect access to some patients. One of the recalls was for Minimed 600 series insulin pumps, a recall announced in 2019 and expanded in October. The recall addresses the risk of incorrect dosing of insulin due to a faulty clear retainer ring, which is used to lock the insulin cartridge into place in the insulin pump reservoir. The second recall is for remote controllers used with Medtronic insulin pumps. In this instance, the action was undertaken due to cybersecurity concerns, although the controllers in question are no longer in distribution.
Medical technology Regulatory Diabetes FDA Product recall

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