Agent skill

Maude Recall Risk

by hh-health-AI in hh-health-AI/healthcare-equity

This skill should be used when the user asks about "MAUDE", "device adverse events", "malfunction reports", "recall risk", "Class I recall", "device franchise at risk", "510(k) predicate safety", or…

MITAuto-check passed

Install Maude Recall Risk

skills CLI
$ npx skills add hh-health-AI/healthcare-equity --skill maude-recall-risk -a claude-code

Project install by default; add -g for ~/.claude/skills/.

GitHub CLI
$ gh skill install hh-health-AI/healthcare-equity maude-recall-risk --agent claude-code

Project scope by default; add --scope user for a personal install. Needs GitHub CLI 2.90.0 or later (public preview).

Manual copy
$ git clone --depth 1 https://github.com/hh-health-AI/healthcare-equity.git skills-src && mkdir -p .claude/skills && cp -r skills-src/modules/fda-safety-signals/skills/maude-recall-risk .claude/skills/maude-recall-risk && rm -rf skills-src

Use ~/.claude/skills/ instead of .claude/skills for a personal install. The folder must contain SKILL.md.

Claude Code skills documentation · loads skills from .claude/skills/

Facts

Skill name
maude-recall-risk
GitHub stars
101
Token cost
~836 tokens
SKILL.md length
430 words
Files
2 (incl. references)
Skills in repo
72
Repo updated
First seen
Licence
MIT

At a glance

This skill should be used when the user asks about "MAUDE", "device adverse events", "malfunction reports", "recall risk", "Class I recall", "device franchise at risk", "510(k) predicate safety", or…

  • Works in 9 steps: Resolve the franchise to device… → Pull the event series… → Normalise, or say you cannot. MAUDE has… → …
  • Asks about MAUDE
  • SKILL.md covers Workflow, Human-factors angle and Not-automatic
  • Instructions only: no scripts, shell commands, URLs or credentials in SKILL.md

What it does

Maude Recall Risk is an agent skill from hh-health-AI/healthcare-equity. This skill should be used when the user asks about "MAUDE", "device adverse events", "malfunction reports", "recall risk", "Class I recall", "device franchise at risk", "510(k) predicate safety", or wants to trend post-market device event reporting for a medtech franchise.

Its SKILL.md is about 840 tokens, which your agent loads only when the skill is triggered. The skill folder holds 2 other files, including reference files (for example `references/maude-mechanics.md`).

The repository describes itself as: Synthesis engine for buy-side healthcare equity research. The licence is MIT.

When your agent uses it

  • Asks about MAUDE
  • Device adverse events
  • Malfunction reports
  • Device franchise at risk

Example prompts

  • “device adverse events”
  • “malfunction reports”
  • “recall risk”
  • “/maude-recall-risk”

Workflow steps

9 steps, taken from the first numbered list in SKILL.md.

  1. Resolve the franchise to device identifiers. Map brand to product codes,
  2. Pull the event series (scripts/openfda_query.py --endpoint device/event),
  3. Normalise, or say you cannot. MAUDE has no denominator either. Where the
  4. Watch the mix, not the total. A rising malfunction count with flat injuries is
  5. Pull enforcement/recall records (/device/enforcement) for the same codes.
  6. Check the regulatory pathway. 510(k)-cleared devices reach market on predicate
  7. Look for the warning letter. FDA warning letters and Form 483 observations are
  8. Size it. Revenue attributable to the affected codes, the switching cost for
  9. Emit the brief.

What it can do on your machine

Read from SKILL.md and the folder at commit 6c7bda8. It shows what the files ask for, not the result of running them.

  • Tool permissions

    Pre-approves nothing: there is no allowed-tools line, so your agent's usual permission prompts apply.

    From allowed-tools in the SKILL.md frontmatter.

  • Runs code

    No scripts in the folder and no shell commands in SKILL.md.

    From the folder's file list and the shell code blocks in SKILL.md.

  • Network

    No URLs in SKILL.md.

    From URLs in SKILL.md, links to its own repository left out.

  • Credentials

    Names no API keys, tokens, secrets or passwords.

    From names ending in _API_KEY, _TOKEN, _SECRET, _KEY or _PASSWORD in SKILL.md.

Context cost

Maude Recall Risk loads about 836 tokens when it runs, and up to ~1.5k if it reads all its reference files. Until then it costs about 73 tokens; SKILL.md has 430 words of instructions outside code blocks.

Always · name and description, kept in context so the agent knows when to use it
~73
When it runs · the whole SKILL.md, loaded when a task matches
~836
With references · SKILL.md plus every file in references/, read only if the agent opens them
~1.5k

Estimates: characters ÷ 4, the usual rule of thumb; real counts depend on the model's tokenizer. Scripts and assets cost tokens only if the agent reads them.

Safety

Auto-check passed

The automated check found no risky patterns in SKILL.md.

Automated static check — not a guarantee. Review scripts before installing. It scans the text of SKILL.md for risky patterns (piping downloads into a shell, reading credential files, hidden Unicode, destructive commands); files beside SKILL.md are not scanned.

SKILL.md

The full file from hh-health-AI/healthcare-equity at commit 6c7bda8, republished under its MIT licence (© hh-health-AI). 430 words, ~836 tokens.

Download SKILL.mdSave it as .claude/skills/maude-recall-risk/SKILL.md (or your agent's skills folder). This skill also uses 1 other file; get the full folder from GitHub.
name
maude-recall-risk
description
This skill should be used when the user asks about "MAUDE", "device adverse events", "malfunction reports", "recall risk", "Class I recall", "device franchise at risk", "510(k) predicate safety", or wants to trend post-market device event reporting for a medtech franchise.
metadata.version
0.1.0
metadata.layer
Regulatory

MAUDE recall risk

Trend device event reporting for a franchise, classify the recall exposure, and size the revenue at risk.

Workflow

  1. Resolve the franchise to device identifiers. Map brand to product codes, 510(k)/PMA numbers, and — where available — UDI/GUDID device identifiers. A medtech franchise usually spans several product codes; missing one understates the trend.
  2. Pull the event series (scripts/openfda_query.py --endpoint device/event), split by event type: malfunction, injury, death. Trend quarterly.
  3. Normalise, or say you cannot. MAUDE has no denominator either. Where the company discloses procedure or unit volumes, normalise to them and say so. Where it does not, use a same-class comparator device's series as the control for market-wide reporting trends, and report only the relative move.
  4. Watch the mix, not the total. A rising malfunction count with flat injuries is a quality-system story. Rising injuries and deaths is a clinical story and a different order of risk. Never report a combined count.
  5. Pull enforcement/recall records (/device/enforcement) for the same codes. Classify: Class I (reasonable probability of serious harm or death), Class II, Class III. Class I is the one that moves numbers.
  6. Check the regulatory pathway. 510(k)-cleared devices reach market on predicate equivalence rather than fresh clinical evidence; published work has associated 510(k) clearance with higher recall rates than PMA. Where a franchise sits on a long predicate chain, that is a standing risk factor to name — and it links directly to a catalyst engine → device-diligence (510(k) predicate validity).
  7. Look for the warning letter. FDA warning letters and Form 483 observations are public and often precede recalls at the same facility. A 483 with repeat observations at a plant that makes the franchise is a strong leading indicator.
  8. Size it. Revenue attributable to the affected codes, the switching cost for hospitals, and whether a same-class competitor has capacity to take the share. A Class I recall on a device with two alternative suppliers moves share fast; one with no substitute produces a shortage, not a share shift.
  9. Emit the brief.
Show full SKILL.md (91 more words)Show less

Human-factors angle

Many device events are use errors rather than device failures, and FDA treats use error as a design problem. A cluster of events describing the same misuse points at a human-factors design deficiency, which is both a recall risk and a regulatory gate for the next-generation device. Cross-read to the desk's human-factors reference in a catalyst engine → device-diligence.

Not-automatic

MAUDE counts do not establish a failure rate, and a recall classification does not establish the size of the affected installed base. Both need company disclosure.

Reference: references/maude-mechanics.md. Contract: ../../references/evidence-brief.md.

© hh-health-AI, MIT. Rendered from Markdown: HTML in the file is shown as text, images as links, and headings moved down two levels. Raw file

Files

SKILL.md and 1 other file (references) in modules/fda-safety-signals/skills/maude-recall-risk of hh-health-AI/healthcare-equity.

  • SKILL.md
  • references/maude-mechanics.md

Open the folder on GitHubat commit 6c7bda8

Compare with similar skills

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Risk Management Specialistalirezarezvani/claude-skills28k1 repos~4.1kAutomated safety check: PassMIT
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Prediction Market Risk Reviewaffaan-m/ECC276k1 repos~471Automated safety check: PassMIT

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Questions about Maude Recall Risk

What does Maude Recall Risk do?

This skill should be used when the user asks about "MAUDE", "device adverse events", "malfunction reports", "recall risk", "Class I recall", "device franchise at risk", "510(k) predicate safety", or…. Maude Recall Risk is an agent skill from hh-health-AI/healthcare-equity. This skill should be used when the user asks about "MAUDE", "device adverse events", "malfunction reports", "recall risk", "Class I recall", "device franchise at risk", "510(k) predicate safety", or wants to trend post-market device event reporting for a medtech franchise.

When should I use Maude Recall Risk?

Maude Recall Risk fits situations like: asks about MAUDE; device adverse events; malfunction reports; device franchise at risk.

How do I install Maude Recall Risk in Claude Code?

Run `npx skills add hh-health-AI/healthcare-equity --skill maude-recall-risk -a claude-code`. Or copy the skill folder (modules/fda-safety-signals/skills/maude-recall-risk in hh-health-AI/healthcare-equity) into .claude/skills/maude-recall-risk in your project. Claude Code loads it when a task matches its description.

How do I install Maude Recall Risk in Codex?

Run `npx skills add hh-health-AI/healthcare-equity --skill maude-recall-risk -a codex`. Or copy the skill folder (modules/fda-safety-signals/skills/maude-recall-risk in hh-health-AI/healthcare-equity) into .agents/skills/maude-recall-risk in your project. Codex loads it when a task matches its description.

Can I use Maude Recall Risk in Cursor, Gemini CLI or GitHub Copilot?

Cursor, Gemini CLI, GitHub Copilot and OpenCode also load SKILL.md folders. With the skills CLI, run `npx skills add hh-health-AI/healthcare-equity --skill maude-recall-risk -a cursor` (or -a gemini-cli, github-copilot or opencode for the others). To copy it by hand, put the folder in .cursor/skills/maude-recall-risk, .gemini/skills/maude-recall-risk, .github/skills/maude-recall-risk and .opencode/skills/maude-recall-risk in your project.

What does Maude Recall Risk need to run?

SKILL.md names no scripts, command-line tools or credentials: Maude Recall Risk is instructions for the agent only.

Does Maude Recall Risk access the network?

SKILL.md contains no URLs. Any network use would come from the scripts or tools the agent runs. This is read from the text; nothing was executed.

Is Maude Recall Risk safe to install?

Our automated static check of SKILL.md found no risky patterns, such as piping downloads into a shell, reading credential files or hidden Unicode. It is not a guarantee. Review the folder before installing.

What licence does Maude Recall Risk use?

Maude Recall Risk is published under the MIT licence (the repository's licence). It allows redistribution, so the full SKILL.md is shown on this page.

How many tokens does Maude Recall Risk use?

About 836 tokens (SKILL.md is roughly 3.3k characters). Agents keep only the skill's name and description in context until a task matches; then they load SKILL.md in full. Its references folder adds about 629 tokens, read only when the agent opens those files.

What are the alternatives to Maude Recall Risk?

Skills that share tags, products or a category with Maude Recall Risk: Risk (alsk1992/CloddsBot, 3k stars), Trader Risk (ruvnet/ruflo, 74k stars), Risk Management Specialist (alirezarezvani/claude-skills, 28k stars) and Conducting Cyber Risk Assessment With Nist 800 30 (mukul975/Anthropic-Cybersecurity-Skills, 34k stars). The comparison table on this page puts their stars, adoption, token cost, safety result and licence side by side.

Who maintains Maude Recall Risk?

hh-health-AI (a GitHub user) maintains it in hh-health-AI/healthcare-equity, which has 101 GitHub stars. The repository holds 72 skills in this directory. The repository was last updated on October 8, 2026.

Source: hh-health-AI/healthcare-equity on GitHub. Facts on this page come from the repository at the commit we read; the author's words are quoted as theirs.