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FDA Recalls

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FDA Enforcement Reports (Recalls)

The FDA Enforcement Reports dataset tracks recalls and enforcement actions for drugs, medical devices, food, and biologics published via the internet Recall Enterprise System (iRES). This MCP lets assistants query recall status, classification, recalling firm, and affected products — refreshed from weekly and daily FDA exports.

Connect

MCP endpoint
https://mcp.polarisray.com/recalls

Transport: http · Auth: none · See the connection guide for client-specific steps.

Tools

  • search_recalls Search enforcement reports by free text and filters — product type, classification, status, firm, geography, date range.
  • semantic_search_recalls Search recalls by meaning over product descriptions and reasons for recall.
  • get_recall Retrieve one recall by recall number / recall id.
  • aggregate_recalls Count and group recalls by classification, product type, firm, status, or as a time trend.
  • resolve Normalize free-text terms to facet labels for precise filtering.

Example questions

  • "Have there been any Class I drug recalls this month?"
  • "List recalls affecting infusion pumps in the last year."
  • "Which firms have the most Ongoing Class I device recalls?"
  • "Find food recalls involving undeclared allergens since 2024."

About this dataset

FDA Enforcement Reports (iRES) list classified and not-yet-classified recalls for drugs, devices, food, biologics, and related product types. PolarisRay downloads the official weekly CSV exports plus the daily “new since last weekly” file into a dedicated recalls database and index (separate from DailyMed / MAUDE / ClinicalTrials).

What you can ask

Filter by Class I/II/III, product type, recalling firm, status, geography, and report date; retrieve a single recall by number; or aggregate trends across the corpus. Search and get hits include an official url field pointing at the FDA iRES record so you can verify what the assistant returned.

Why PolarisRay

Fewer tokens. Search by meaning.

Answer-ready results with far less context than raw APIs — plus concept search the official FDA API can't do.

See why PolarisRay →