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FDA Medical Device Recalls

openfda_devices.safety.recalls
Read-onlyIdempotent

Search FDA medical device recall records — 58,000+ recalls across all device types since 1976. Returns recall status (Ongoing/Terminated/Completed), reason for recall, affected product descriptions, recalling firm, distribution pattern, corrective action taken, and product codes. Filter by device name, firm, status, or date using Lucene syntax: device_name:"insulin pump" or recall_status:"Ongoing". Essential for medical device safety research, regulatory compliance, and patient risk assessment. Source: FDA CFRES database, US public domain.

Input Schema

TableJSON Schema
NameRequiredDescriptionDefault
skipNoNumber of records to skip for pagination (default 0).
limitNoNumber of records to return (1–99, default 10).
searchNoOpenFDA search expression using Lucene syntax. Single field: device_name:"pacemaker" or recall_status:"Ongoing". Combined: device_name:"insulin pump"+AND+recall_status:"Ongoing". Omit to return recent records sorted by date.

Output Schema

TableJSON Schema
NameRequiredDescriptionDefault
errorNoPresent only when the call failed. Includes error code, message, request_id, and any provider-specific extras.
resultNoTool response payload. Shape varies per tool — consult the tool description and inputSchema. May be an object, array, string, or number depending on the upstream provider response.

Schema Changelog

Changes observed during successful MCP inspections.

  1. First observed

TDQS

A4.3/5.0
Behavior4/5

Does the description disclose side effects, auth requirements, rate limits, or destructive behavior?

Annotations already establish readOnlyHint, openWorldHint, idempotentHint, and destructiveHint=false, so the bar is lower. The description adds useful behavioral context: coverage since 1976, 58,000+ records, returned recall fields, and the source database. No contradiction with annotations.

Agents need to know what a tool does to the world before calling it. Descriptions should go beyond structured annotations to explain consequences.

Conciseness4/5

Is the description appropriately sized, front-loaded, and free of redundancy?

The description is well structured and front-loaded: it opens with the core action and scope, then adds return fields, filter syntax, and provenance. The 'Essential for...' clause is mildly promotional but still provides useful selection context.

Shorter descriptions cost fewer tokens and are easier for agents to parse. Every sentence should earn its place.

Completeness4/5

Given the tool's complexity, does the description cover enough for an agent to succeed on first attempt?

For a read-only, optional-parameter search tool with an output schema, this is nearly complete: it covers dataset scope, filters, Lucene syntax, return payload highlights, source, and use cases. The only small gap is that 'date' filtering is mentioned without an exact field name, though the example fields cover the main use cases.

Complex tools with many parameters or behaviors need more documentation. Simple tools need less. This dimension scales expectations accordingly.

Parameters4/5

Does the description clarify parameter syntax, constraints, interactions, or defaults beyond what the schema provides?

Schema coverage is 100%, so the baseline is 3. The description adds meaning beyond the schema by mapping the generic search parameter to specific fields (device_name, recall_status) and demonstrating Lucene syntax with 'or'. Skip and limit are left to the schema, which fully documents them.

Input schemas describe structure but not intent. Descriptions should explain non-obvious parameter relationships and valid value ranges.

Purpose5/5

Does the description clearly state what the tool does and how it differs from similar tools?

States an explicit action ('Search') on a concrete resource ('FDA medical device recall records'), scopes it by dataset size and time range, and lists the return fields. It distinguishes itself from sibling tools like fda_openfda.safety.drug_recalls or vehicle.safety.recalls by naming medical devices and the FDA CFRES source.

Agents choose between tools based on descriptions. A clear purpose with a specific verb and resource helps agents select the right tool.

Usage Guidelines4/5

Does the description explain when to use this tool, when not to, or what alternatives exist?

Provides clear when-to-use guidance via stated filterable fields, Lucene syntax examples, and use cases such as 'medical device safety research, regulatory compliance, and patient risk assessment.' It does not explicitly name sibling alternatives or state when not to use it, but the context is strong enough for an agent to select it correctly.

Agents often have multiple tools that could apply. Explicit usage guidance like "use X instead of Y when Z" prevents misuse.

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