February 20, 2023

Recall Classification: U.S. FDA

For the U.S. FDA, a risk-based approach is required for categorizing a recall; for planning and implementing a recall (e.g., to assure proper recall depth and effectiveness); for resolving the issues that caused the recall; for writing the recall notification, etc., etc.

First, a proposed remedial action needs to be properly categorized using the following terms, as applicable:

• Correction: Repair, modification, adjustment, relabeling, destruction, or inspection (including patient monitoring) of a product without its physical removal to some other location.

• Removal: The physical removal of a device from its point of use to another location for correction.

• Recall: A manufacturer’s or distributor’s removal or correction of a product marketed in the U.S. that the Food and Drug Administration considers to be in violation of the laws it administers and against which the agency would initiate legal action, e.g., seizure. Recall does not include a market withdrawal or a stock recovery.

• Market Withdrawal: A manufacturer’s or distributor’s removal or correction of a distributed product which involves a minor violation that would not be subject to legal action by the Food and Drug Administration or which involves no violation, e.g., normal stock rotation practices, routine equipment adjustments and repairs, etc.

Again, the associated risk will have a considerable impact on which of these categories apply.  Remember to characterize the risk in terms of the frequency and severity of harm associated with the issue.

For any recall queued from the aforesaid qualitative categorizations, the recall needs to be classified as either class I, II, or III:

• 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.

• Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

• Class III: A situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.

Some will say that a firm’s classification of a recall is only voluntary since FDA will ultimately assign the recall classification for U.S. recalls (i.e., generally class I and II recalls) reported to the FDA. Nonetheless, I recommend that the recalling firm always suggest a classification to FDA, and to do so based on the outcome of the firm’s internal Health Hazard Assessment (HHA) or Health Risk Assessment (HRA) performed to mimic FDA’s own internal operating procedures.  Moreover, even if a firm decides not to report a recall to the FDA (i.e., class III recalls only), then the firm is still basically obligated to, at least internally, apply and record its class III recall classification and corresponding rationale.  So, in these terms, U.S. recall classification is not really voluntary for the recalling firm.

Ultimately, be sure your U.S. FDA recall procedures clearly and properly address these various aspects of recall categorization.  If you need assistance with this, then ComplianceAcuity would be glad to help.  This is important, not only for assuring proper remedial action categorization, but also, for example, to avoid confusion regarding other jurisdictions’ similar/identical terms (e.g., EU MDR/IVDR “Recall” and ” Withdrawal”), which nonetheless don’t have the same meanings as the U.S.’s definitions of “Recall”, “Market Withdrawal”, etc.