Methodology & data sources

How RegWarden compiles these records, what they mean, and where to verify them.

Where the data comes from

Every page is built from the U.S. Food and Drug Administration’s public data. Facility and device details and recalls come from openFDA (opens in a new tab) — the device registration & listing and enforcement (recall) datasets. Inspection classifications (NAI / VAI / OAI) and warning letters come from the FDA Data Dashboard (opens in a new tab) (inspection and compliance-action records). Every fact carries a link back to its FDA source, so it can be checked directly.

How we connect recalls to companies

Facilities are keyed on the FDA Establishment Identifier (FEI), a stable per-establishment number. Recall records, however, carry no FEI — they name a recalling firm as free text. We resolve each recall to a company by matching that firm name and address against the registered establishments, and we deliberately attribute a recall to the company rather than guessing a single facility, because the source data does not identify one. Where a company has exactly one registered facility, the recall is shown against it; otherwise we link to the company’s full facility list. Inspections and warning letters, by contrast, carry an FEI, so they attach directly to the specific facility.

What we publish — and what we don’t

We restate the public record as measured facts: recalls and the FDA’s own severity classification, inspection classifications (NAI / VAI / OAI), warning letters, dates, and reasons — or plainly that none are on record. We do not score, rank, or issue risk verdicts, and we do not infer anything the FDA did not publish.

How current it is

Recall data is refreshed weekly and registration roughly monthly; inspection classifications and warning letters refresh weekly. Every page carries a “data as of” date, and this snapshot reflects data as of 2026-10-06. Warning letters can take up to several weeks after issuance to be posted on FDA.gov, so the most recent letters we list may not yet be publicly available there; letter links open an FDA search that resolves once posted.

Scope & limitations

Coverage is currently U.S. medical-device facilities, with FDA recalls, inspection classifications, and warning letters. Foreign establishments and recalls with sparse identifying information may resolve less completely.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.