A recall strategy has a grade. openFDA doesn't.

Two device recalls can carry the same Class I designation and still commit their firms to entirely different amounts of work. The health hazard evaluation under 21 CFR 7.41 answers how dangerous a defect is. A separate document — the recall strategy required under 21 CFR 7.42 — answers how far the firm has to chase it, and openFDA’s public enforcement record does not carry that second document at all.

Three elements, one strategy

21 CFR 7.42(a) has a firm build its recall strategy around the health hazard evaluation’s findings, plus how easy the product is to identify, how obvious its defect is to the person holding it, how much of it is still sitting unused in the market, and whether pulling it would create a shortage of something essential. Paragraph (b) then fixes three concrete elements the strategy has to commit to.

Depth of recall

The first element is depth: how far down the distribution chain the recall has to reach. The regulation sets three levels — consumer or user level, which can include any intermediate wholesale or retail level; retail level, including any intermediate wholesale level; or wholesale level alone. A wholesale-level recall never has to reach the clinician or patient holding the device; a consumer-level recall does. Two recalls of the same product, at two different points in its life, can land at two different depths for the same underlying defect, because depth follows distribution and severity together, not severity alone.

Public warning and effectiveness checks

The second element is whether a public warning goes out — reserved, by the regulation’s own terms, for urgent situations where notifying consignees directly would not be enough to keep the product out of use. The third is the effectiveness-check grade: how thoroughly the firm has to confirm that consignees actually got the message and acted on it, graded from Level A — contacting 100 percent of consignees — down through Level D, roughly 2 percent. It is a documented, FDA-reviewed commitment to verification, not a courtesy follow-up.

None of it is a public field

openFDA’s device enforcement endpoint — the same API behind FDA Radar’s recall coverage — carries a recall’s classification, its reason, its product quantity, and a distribution_pattern field limited to where the firm first shipped the product. It has no field for depth of recall, none for whether a public warning issued, and none for the effectiveness-check grade. The strategy a firm actually committed to, and FDA actually reviewed, is a document exchanged between the firm and FDA’s recall coordinators — not a record the enforcement report was ever built to carry.

The practice

Reading a Class I designation as the whole picture of a recall’s reach is a common shortcut, and an incomplete one. Classification says how bad the defect is; it says nothing about whether the firm is chasing every unit in a hospital’s supply closet or only the ones still on a distributor’s shelf. Where that distinction matters — assessing a competitor’s exposure, or your own — the enforcement report is a starting point, not the strategy itself; the depth and the grade behind a specific recall have to be requested directly, from the firm or from FDA, when they matter to the decision at hand. This is regulatory intelligence about what the public record does and doesn’t carry, never regulatory advice about how deep a specific recall should reach.