2 medical device recalls to know

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The FDA has flagged two Class I medical device recalls and corrections, affecting blood glucose monitors and insulin pumps.

Here are two recalls to know:

  1. Blood glucose monitors (Trividia Health): On April 28, Trividia issued a correction for True Metrix blood glucose monitoring systems due to an issue with the E-5 error code, which may indicate either very high blood glucose levels or a test strip error. Misinterpretation could delay treatment or lead to improper treatment, with risks including loss of consciousness or death. The FDA reported 114 serious injuries and one death.
  2. Insulin pumps (Insulet): On April 30, Insulet recalled certain Omnipod 5 Pods due to a defect that may cause insulin under-delivery. The issue could lead to high blood glucose levels and, in severe cases, diabetic ketoacidosis. The FDA reported 29 serious injuries and no deaths.

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