Official source
Preserved FDA/openFDA facts
Identifiers, firm wording, product descriptions, recall reasons, dates, classifications, distribution text, and joined device evidence are shown as source facts with provenance.
Methods · provenance · freshness
Check how the record was counted before citing it.
Recall Observatory is an independent research utility built from public FDA/openFDA records. This page states what the app preserves, what it derives, and what the current corpus can support.
Counting rules
Events and products answer different questions.
- Recalled product
- One official FDA enforcement record. Product counts use this unit.
- Recall event
- Products grouped only when they share the same usable official event identifier. Missing, malformed, or ambiguous identifiers are never repaired by inference.
- Timeline date
- Products use their official recall-initiation date. Events use the earliest available initiation date among their products. Undated records remain visible outside chart buckets.
Evidence boundary
Official facts stay separate from app interpretation.
Derived
Published deterministic interpretation
Failure modes are non-exclusive labels derived from preserved recall-reason language. Each label exposes its versioned rule and exact supporting official excerpt.
Audit the current failure-mode catalog- ? Unknown
- Relevant source material exists, but it supports no named conclusion.
- Unavailable
- The relevant public source or enrichment record is absent.
Interpretation rules
Formatting is not identity, and source text is not an estimate.
- Firm keys normalize case, whitespace, and punctuation only. They map to a first-class Firm record, but they do not merge corporate families or imply common ownership.
- Device root-cause evidence is sourced only through documented official identifiers; conflicting candidates remain ambiguous.
- Failure-mode version 1.0.0 assigns every available unmatched recall reason to Unknown; blank reasons receive no assignment. Counts are generated from these persisted outcomes, not copied into documentation.
- Distribution and quantity remain source wording. The app does not infer affected people, exposure, places, or risk.
- The corpus is for historical research, not medical advice, real-time alerts, company safety rankings, or FDA lifecycle tracking.
Current source registry
Latest source check and published import
| Source | Report-date coverage | Latest metadata check | Latest published import | Publication state |
|---|---|---|---|---|
| openFDA Device Recall Metadata · Official data | June 01, 1997 through June 30, 2026 Bounds use FDA report dates; initiation dates in the chart may be earlier. | Check succeeded | 58,737 source records Fingerprint 5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c | Published corpus current No later source change is recorded. |
| openFDA Device Enforcement Metadata · Official data | June 20, 2012 through July 08, 2026 Bounds use FDA report dates; initiation dates in the chart may be earlier. | Check succeeded | 39,519 source records Fingerprint 191b1235443d1a377405f5df6a8cc172a6029fab700b9bca1692428fddc56e5b | Published corpus current No later source change is recorded. |
| openFDA Drug Enforcement Metadata · Official data | June 20, 2012 through July 08, 2026 Bounds use FDA report dates; initiation dates in the chart may be earlier. | Check succeeded | 17,793 source records Fingerprint 02ea6bc2d57c019917ec07e78ca6919c6117e069f5e3e5c8dc62a20efd077ffb | Published corpus current No later source change is recorded. |
| openFDA Food Enforcement Metadata · Official data | June 20, 2012 through July 08, 2026 Bounds use FDA report dates; initiation dates in the chart may be earlier. | Check succeeded | 29,224 source records Fingerprint a8ed3f13b50914790604e363ee373bb3fa89c511b913651715cc84d3b0a82ec1 | Published corpus current No later source change is recorded. |
Coverage and known gaps
A gap is a warning, never a zero.
openFDA Device Recall
Device · Device enrichment
No known report-date gap is recorded for this stated covered range. Recall-initiation dates may precede it; this is not a claim of universal completeness.
openFDA Device Enforcement
Device · Enforcement
-
Report-date coverage gap
2004-01-01 to 2012-06-19
openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
Open gap evidence
openFDA Drug Enforcement
Drug · Enforcement
-
Report-date coverage gap
2004-01-01 to 2012-06-19
openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
Open gap evidence
openFDA Food Enforcement
Food · Enforcement
-
Report-date coverage gap
2004-01-01 to 2012-06-19
openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
Open gap evidence