Methodology · v3.1

DDRHDrug & Device Recalls

Documented FDA / EMA / national drug & device recalls against {legal_name} in last 5y. EXTRACTION RULES: NEGATIVE-SIGNAL, SUSPICIOUS-ON-ZERO. Search ALL of: FDA Enforcement Reports (fda.gov/safety/recalls-market-withdrawals-safety-alerts), EU Safety Gate, MHRA UK, AIFA recall registry, PMDA recall list. Return type="enumerated_events" with each event: date+url+severity (FDA Class I=critical, Class II=major, Class III=minor)+description with product + lot. MANDATORY URL on regulator host. ZERO-EVENTS IS NOT AUTO-95: returning an empty array does NOT auto-produce the top score — the server treats this index as suspicious-on-zero and will VERIFY/RETRY a clean record rather than publish 95. Only conclude "no recalls" AFTER searching EACH named register above; in _reasoning state which regulator hostnames you queried over the explicit 60-month window and that NO recall was found. Never return [] out of uncertainty. N/A PATH: if {legal_name} is verifiably NOT a manufacturer/distributor of products regulated in any FDA/EMA/MHRA/AIFA/PMDA market, return type="absent" reason="no_company_specific_data" (clean not_applicable) instead of an empty-events score.