{ "$schema": "http://json-schema.org/draft-07/schema#", "title": "Medical Device Recall", "description": "Medical device recall notice from the FDA or equivalent regulatory authority.", "type": "object", "properties": { "recall_id": { "type": "string", "description": "Regulatory recall identifier. Commonly found in: FDA recall database, recall notice." }, "device_name": { "type": "string", "description": "Name of the recalled device. Commonly found in: FDA recall notice, press release." }, "device_model": { "type": "string", "description": "Model number or name. Commonly found in: FDA recall notice, device label." }, "device_type": { "type": "string", "description": "Type or category of medical device. Commonly found in: FDA device classification, recall notice." }, "manufacturer_name": { "type": "string", "description": "Name of the device manufacturer. Commonly found in: FDA recall notice, press release." }, "manufacturer_country": { "type": "string", "description": "Country of the manufacturer. Commonly found in: FDA recall notice, manufacturer address." }, "recall_class": { "type": "string", "enum": ["I", "II", "III", "other"], "description": "FDA recall class (I = most serious). Commonly found in: FDA recall database." }, "recall_type": { "type": "string", "enum": ["voluntary", "mandatory", "other"], "description": "Whether the recall was voluntary or mandatory. Commonly found in: FDA recall notice." }, "recall_status": { "type": "string", "enum": ["ongoing", "terminated", "completed", "other"], "description": "Current status of the recall. Commonly found in: FDA recall database." }, "initiated_date": { "type": "string", "format": "date", "description": "Date the recall was initiated. Commonly found in: FDA recall notice." }, "terminated_date": { "type": "string", "format": "date", "description": "Date the recall was terminated. Commonly found in: FDA recall database." }, "reason_for_recall": { "type": "string", "description": "Reason or root cause for the recall. Commonly found in: FDA recall notice, press release." }, "hazard_to_health": { "type": "string", "description": "Description of the health hazard. Commonly found in: FDA recall notice." }, "units_affected": { "type": "number", "description": "Approximate number of units affected. Commonly found in: FDA recall notice, press release." }, "lot_numbers": { "type": "array", "items": { "type": "string" }, "description": "Affected lot or batch numbers. Commonly found in: FDA recall notice." }, "distribution_scope": { "type": "array", "items": { "type": "string" }, "description": "Geographic scope of distribution. Commonly found in: FDA recall notice." }, "action_required": { "type": "string", "description": "Required action for customers or healthcare providers. Commonly found in: FDA recall notice, press release." }, "patient_risk_level": { "type": "string", "enum": ["high", "medium", "low", "other"], "description": "Assessed risk level to patients. Commonly found in: FDA recall classification." }, "press_release_url": { "type": "string", "description": "URL of the manufacturer press release. Commonly found in: manufacturer website, FDA press release." }, "page_title": { "type": "string", "description": "Title of the source page. Tabstack auto-fills this from page metadata when left empty." }, "favicon": { "type": "string", "format": "uri", "description": "Favicon URL of the source page. Tabstack auto-fills this from page metadata when left empty." } }, "required": ["device_name", "manufacturer_name", "recall_class", "recall_status", "initiated_date", "reason_for_recall"] }