Ongoing, as of when?
openFDA's recall status field reads like a live indicator — Ongoing, Completed, Terminated. FDA's own documentation says it isn't one. What gets corrected on a recall record after it posts, what doesn't, and the practice for telling the difference.
By Connor Griggs — Regulatory & Quality Strategist
Pull a device recall record from openFDA and one field looks built to update itself: status, holding one of three values — Ongoing, Completed, or Terminated. It reads like a tracking number, the kind of field worth checking again next month to see whether the word has caught up with what happened. It has not. FDA says so plainly — in a sentence that lives on a definitions page, not on the field itself.
What FDA actually commits to
FDA’s own enforcement report documentation states the rule without hedging: the agency does not update the status of a recall once it has been classified, and the status shown in a published Enforcement Report — open, completed, or terminated — remains exactly as published. A record reading Ongoing today is reporting the state FDA recorded at classification, on that date. Nothing downstream promises to revisit it. The field is not live. It is timestamped, wearing a live field’s vocabulary.
What does get corrected, and what doesn’t
The record is not frozen end to end. FDA separately tracks later corrections to four fields — product description, reason for recall, classification, and code information — through an Update History section on the record itself and a Recently Updated flag on search results, for recalls posted or updated from July 2018 forward. Status is not one of the four. FDA will revise what a recall is about, on the record, dated. It has not committed to revising whether the record still calls it open.
Termination has real criteria — they are just not visible in the field
None of this makes “terminated” an empty label where it does appear. 21 CFR 7.55 sets a real bar: FDA terminates a recall once it determines that all reasonable efforts to remove or correct the product have been made, and it is reasonable to assume the disposition or correction accomplished is commensurate with the hazard. A firm can request termination directly — in writing, to its FDA district office, with a current status report and a description of the product’s disposition. Termination is a determination with real inputs behind it. It just does not reach backward and rewrite every earlier report that called the same recall Ongoing.
The practice
Read statusas a fact about the report’s publication date, not about today. If a recall is worth tracking — a supplier, a device cited as a predicate, a product code in your portfolio — the word on the record you first pulled is not where its resolution will announce itself. Re-pull the record, or check FDA’s enforcement report search directly, rather than trusting a saved response to have kept up on its own. A stale “Ongoing” is closer to an unanswered question than a comforting confirmation: the field’s silence is not evidence that a recall is still open, only evidence that no later report has told this particular copy otherwise.
Whether a given recall is closed enough to stop watching is a judgment for whoever owns that portfolio, made on the current record — this is a description of what one field does and does not promise, not a determination about any specific recall. FDA Radar’s ingest job re-fetches the enforcement window on every run and hashes each record it already holds by recall number; if the same recall comes back with status changed, or anything else in it changed, that is a different hash, and it surfaces as a revision for a reviewer rather than sitting unchanged in the corpus because nobody thought to look again.
Primary sources
- FDA — Enforcement Report Information and Definitions
- FDA — Enforcement Report History Feature
- 21 CFR 7.3 — Definitions
- 21 CFR 7.55 — Termination of a recall
- openFDA — Device Enforcement overview
Regulatory intelligence, not regulatory advice. This post describes method and published FDA records as of its date; decisions about a specific device belong with your regulatory professional.