Completed. Not terminated.

A device recall in FDA’s public enforcement record carries a status field with three possible values, and two of them read as near-synonyms until the rule behind them says otherwise. Completed is the firm’s own account of its work. Terminated is FDA’s.

Three words, two different authors

FDA’s own enforcement-report definitions treat all three status words as distinct events, not stages of the same sentence. Ongoing means the recall action is still in progress. Completed means the firm has retrieved, corrected, or otherwise accounted for everything it can reasonably expect to recover — the firm’s own statement that its work is done. Terminated is a different kind of event entirely: under 21 CFR 7.55, a recall is terminated only when FDA determines that all reasonable efforts have been made in accordance with the recall strategy, and that it is reasonable to conclude the product has been removed or corrected commensurate with the degree of hazard. A firm can declare its own work Completed. Only FDA can declare a recall Terminated, and the district office issues that determination in writing.

The step the status field skips over

Between those two words sits the mechanism that is supposed to justify moving from one to the other. 21 CFR 7.42 requires every recall strategy to specify a level of effectiveness check — verification, down the distribution chain, that consignees actually received the recall notice and acted on it. FDA’s guidance sets four levels by the share of consignees to be checked: Level A reaches 100 percent, Level B some case-by-case share between 10 and 100 percent, Level C 10 percent, and Level D 2 percent. The recalling firm ordinarily runs the checks itself; FDA assists only where necessary. Nothing in the public status field says which level applied or whether the checks are finished — that work can still be running underneath a record that already reads Completed.

What the gap actually tells a reader

A recall parked at Completed for months is not necessarily stalled. It can mean the firm has finished its side and FDA’s own review of the strategy, the effectiveness checks, or the periodic status reports a firm files under 21 CFR 7.53 simply hasn’t concluded yet. It can also mean exactly what it looks like — a recall sitting in a queue. The status field alone doesn’t distinguish the two, and reading Completed as synonymous with resolved skips the one step — FDA’s own determination — that the word Terminated is reserved for.

Completed is the firm’s word for its own work. Terminated is FDA’s word that the work actually held.

The practice

Before treating a recall as resolved, check which of the three words the record actually uses. Ongoing means active. Completed means the firm says it’s done. Only Terminated means FDA agreed. A supplier or predicate review asking whether a recall has genuinely closed should look for the third word specifically, not stop at the second one because it reads like an ending.

FDA Radar’s recall ingest carries this field as FDA publishes it, unedited, in an item’s underlying record — Ongoing, Completed, and Terminated stay three separate values, never collapsed into one status a reader has to unpack for themselves. What a specific recall’s current status means for a specific supplier relationship is a judgment for a regulatory or quality professional working that file — regulatory intelligence and method, never regulatory advice.