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, retrieved through openFDA. Facility and device details come from the device registration & listing dataset; recall details come from the device enforcement (recall) dataset. Every facility, company, and recall page links back to the exact openFDA query, so any fact can be checked at the source.

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.

What we publish — and what we don’t

We restate the public record as measured facts: “recall on record,” “no recalls on record,” the FDA’s own severity classification, dates, and reasons. 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 data roughly monthly; every page carries a “data as of” date. This snapshot reflects data as of 2026-08-13.

Scope & limitations

Coverage is currently U.S. medical-device facilities with FDA recall history. Inspection and warning-letter records are being added. Foreign establishments and recalls with sparse identifying information may resolve less completely.

Source: U.S. FDA via openFDA (device registration & enforcement). Data as of 2026-08-13. We restate the public record only — measured facts, never risk verdicts.