1 Answer 1


Class I that you see on the FDA recall page is actually a classification of the recall itself:

Class I - a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.

The device itself is Class 2. You can verify it by clicking on the "Pump, infusion" link on the FDA recall page here.

  • i see, then where in API i can get recall's class?
    – svetlana
    Aug 22, 2023 at 7:01
  • Unfortunately, this information is not available via the API. But we will work on adding it at some point in the future. Aug 24, 2023 at 15:18

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