Editorial policy
Last updated Oct 16, 2026.
Device Safety Index exists for one reason: to make the FDA's public medical device safety records easy to find and understand for patients, caregivers and clinicians. This page explains the rules we follow so you can judge how far to trust what you read here.
1. Official data only
Every device detail, adverse event report and recall on this site comes from three public FDA datasets — GUDID, MAUDE and Medical Device Recalls — downloaded in bulk through openFDA. We do not add information from manufacturers, press releases, social media or lawsuits, and we do not publish user comments or reviews. Each page links to the original FDA records so you can check them yourself.
2. We report, we do not judge
- We never call a device "safe", "dangerous", "best" or "worst", and we do not rank devices against each other. Report counts depend on how many devices are in use and how often problems are reported, so they cannot measure risk on their own.
- Report narratives are shown exactly as the FDA publishes them, without editing.
- Nothing on this site is medical advice. Pages remind readers to talk to their healthcare provider and not to stop using a prescribed device on their own.
3. How pages are written
Device pages are built automatically from the data, using fixed templates. Pages with too little data to be useful are kept out of search engines. The exact matching rules — which reports and recalls are attached to which device, and why — are published in How the data works.
4. How we use AI
Some device pages carry a short "Quick summary" written by an AI model (Claude, by Anthropic). The model sees only the FDA records shown on that page and is instructed not to add outside facts or give safety verdicts. Before anything is published, a script checks every number in the summary against the data and rejects summaries that contain verdicts, advice or unsupported claims. AI summaries are always labelled, and the records below them remain the source of truth.
5. Independence and money
- We are not affiliated with the FDA, any government agency, any device manufacturer or any law firm.
- No one can pay to add, remove, change or reorder information on this site.
- The site may show advertising to cover its costs. Ads are labelled "Advertisement", are kept visually separate from the data, and advertisers have no influence over content. We do not sell personal data.
6. Keeping it current
We check openFDA for new files regularly and rebuild the site when the FDA publishes new data. Every device page shows when its data was last updated. The current data was built on Oct 13, 2026 from FDA files dated Oct 13, 2026 (devices), Oct 13, 2026 (reports) and Oct 13, 2026 (recalls).
7. Corrections
If something looks wrong — a report on the wrong device, a broken link, a confusing sentence — use the "Report an error" link on any page or the contact form. We read every message and reply when we can if you leave an email address. When a mistake is on our side (matching, display or wording) we fix it and rebuild the affected pages. If the error is in the FDA record itself, we will tell you how to report it to the FDA or the manufacturer, because we do not alter official records.
Significant corrections are listed below.
- No corrections yet.
8. Privacy
FDA adverse event reports are published by the FDA with patient identities removed. We do not try to identify anyone in them. How we handle visitor data is described in our privacy notice.