FDA Recalls: The Health Hazard Evaluation Sets the Class

A recalling firm proposes a strategy. It does not assign the class. Under 21 CFR Part 7, Subpart C, FDA runs its own health hazard evaluation and classifies every recall as Class I, II, or III — and that classification, not the company's own risk narrative, decides how deep the recall has to reach, whether a public warning is required, and how long the field action stays open.

The evaluation FDA runs before it assigns a class

Once FDA is notified of a recall, or considering initiating one on its own authority, an ad hoc committee of agency scientists conducts the health hazard evaluation described in §7.41. The committee weighs whether disease or injury has already occurred, whether any existing conditions could turn the exposure into a genuinely hazardous clinical situation, and how the hazard falls across different segments of the population — with particular attention to whoever is at greatest risk. It then assesses the seriousness of the hazard, the likelihood it actually occurs, and the immediate and longer-range consequences if it does. The inputs to that evaluation are frequently the same records a mature complaint handling and MDR reporting system already produces — which is why firms with thin complaint files tend to get classified against, not with, the benefit of the doubt.

Correction, removal, and the two things that are neither

§7.3 defines a correction as repairing, modifying, adjusting, relabeling, destroying, or inspecting a product without moving it — and a removal as physically moving it elsewhere for the same purpose. A recall is the firm's voluntary use of one or the other to address a product that violates the law. Two adjacent terms get mistaken for recalls constantly, and the distinction matters because neither one carries a recall classification or, in most cases, a Part 806 report:

• Correction. Repair, relabeling, or in-place inspection of product that stays where it is — a hospital's field-service update is a correction, not a removal.
• Removal. Physical relocation of the product away from its point of use for repair, destruction, or inspection.
• Market withdrawal. Removing or correcting a minor violation not subject to legal action — routine stock rotation, for example — with no health hazard involved.
• Stock recovery. Removal of a violative product that has not yet left the firm's direct control, so it never reached a customer or user.

Classification is not a formality applied after the fact. It decides the depth of the recall, whether a public warning is required, and how the termination letter eventually reads. Why the health hazard evaluation comes before the strategy

What decides recall strategy, and when it ends

§7.42 ties recall strategy — how deep the recall reaches (consumer or user level, retail level, or wholesale level only) and whether public notification is warranted — to the health hazard the classification identified. A Class I recall of product already in patients' hands calls for a materially different strategy than a Class III labeling correction sitting in distributor warehouses. The recall stays open, and FDA keeps checking on it, until the agency is satisfied under §7.55 that the firm's corrective action was effective and the grounds for continuing have been resolved; only then does FDA issue a termination letter. Firms that treat CAPA remediation as a parallel, disconnected workstream routinely extend their own recalls by months, because the termination evidence FDA is waiting on was never built into the plan.

None of this is exotic once it is sequenced correctly. It is a bounded body of work: an honest health hazard assessment, a strategy scaled to the classification rather than to internal comfort, a Part 806 report that runs on the regulation's clock rather than the legal team's, and a termination package built alongside the recall instead of after it. Keep in mind that Part 806's correction-and-removal reporting is a separate obligation from adverse-event reporting — see the 5-day and 30-day MDR reportability clock for the distinction most teams conflate. A field action tests inspection readiness as much as any scheduled visit does; the firms that hold up are the ones that treated classification as FDA's decision from the start, not a negotiation.