williamTLmiller/fda-medical-device-recalls-510k-openfda

FDA Medical Device Recalls, Enforcement Reports & 510(k)/PMA Approvals (openFDA, Normalized)

Release name: SafetyGraph v1 — Free Sample

A ~10% sample of the MatrixNorm SafetyGraph build over openFDA's device regulatory endpoints, under CC BY-NC 4.0 (non-commercial, attribution). The full dataset is licensed separately.

Sample rule: recall, enforcement and premarket records with sha1("sample:" + record_id)[0] < 26, plus the whole classification table; every other stream is filtered to stay closed over that set (an atom is kept only when its subject and every cited span are kept). Records with a personal-data privacy finding are excluded.

Sources

openFDA device endpoints: recall, enforcement, 510(k), PMA, classification (public domain, CC0 1.0). MAUDE adverse events are published separately as MatrixNorm MAUDENorm; UDI/GUDID is not included in this version.

Contents

Path	Contents
canonical/<kind>.jsonl.gz	One normalized record per line, with field states, withheld fields and source locator
extended/evidence.jsonl.gz	Character-level evidence spans back into the source record
extended/atoms.jsonl.gz	Reasoning atoms (regulatory status, recall reason, root cause, temporal order, identity…), each citing evidence
extended/identity_candidates.jsonl.gz	Cross-record links (exact, classified-as, references-submission) with basis and evidence
graph/nodes.jsonl.gz, graph/edges.jsonl.gz	The typed graph over records, atoms and reported organisations
tasks/splits.jsonl.gz	Leakage-safe grouped split (98/1/1) per record

Stream	Rows
canonical/regulatory_classification	7,096
canonical/recall_action	5,884
canonical/enforcement_action	3,980
canonical/premarket_record	23,963
extended/evidence	246,514
extended/atoms	150,995
extended/identity_candidates	38,017
graph/edges	260,300
graph/nodes	203,786
tasks/splits	40,923

Split: train 40,191 / validation 335 / test 397 (grouped so linked records never straddle splits).

Quality

Build audit at packaging time passed: atom evidence, graph, leakage, output hashes, raw receipts, replay, schemas. Every atom cites evidence spans with character offsets into the source record. No engine routing fields are shipped.

Limits

• Labels and links are produced by a deterministic extractor (silver), not human-reviewed.
• Free-text FDA notices contain firm contact phone numbers and emails as published by the FDA.
• Not produced or endorsed by the FDA; not medical or regulatory advice.

License

CC BY-NC 4.0 (LICENSE) for williamTLmiller's normalization and packaging work; the openFDA data itself is CC0 (LICENSE-CC0-1.0-UNDERLYING-openFDA.txt). See NOTICE.

Built 2026-10-31T09:06:22Z. Contact: energea@energeatech.com