The U.S. Food and Drug Administration (FDA) emphasizes the importance of being prepared for device recalls.

FDA product recalls are on the rise in the post-pandemic era. There has been a clear upward trend from 2021 through 2023, and medical devices ranked the highest of all product types. (See Figures 1 and 2.)

Recall means a firm’s removal or correction of a marketed product that the FDA considers to be in violation of the laws it administers, and against which the agency would initiate legal action, e.g., seizure. Recall doesn’t include a market withdrawal or a stock recovery. 

Recall strategy means a planned course of action to be taken when conducting a specific recall, which addresses the depth of recall, need for public warnings, and extent of effectiveness checks for the recall.

Figure 1: Recalled products by fiscal year

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