The Comment Period, Ep. 4: Recall Me, Maybe?

When a potential product problem surfaces, determining what happens next can require companies to move quickly while assessing risk, regulatory obligations, and potential consequences.

In Episode 4 of The Comment Period, Mark Gardner and Nathan Downing are joined by Gardner Law Associate Attorney and mechanical engineer, Brynn Stanley, to discuss FDA recalls and other field actions. The conversation covers Class I, II, and III recalls, health hazard evaluations, market withdrawals, medical device reporting, postmarket surveillance, and the role of risk management documentation in determining an appropriate response.

They also discuss working with FDA during a recall, the importance of having strong quality systems and documentation in place before a problem arises, and the legal consequences that can follow a field action. One theme runs throughout the episode: when a potential recall issue surfaces, delay can make an already difficult situation harder to manage.

The Comment Period: Recall Me, Maybe: Navigating FDA Recalls, Risk, and Response, is now open.

Watch below, or listen and subscribe on Spotify, YouTube, or Apple Podcasts