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Recalls Safety

FDA Medical Device Recall Quarterly Archive

FDA Medical Device Recall Quarterly Archive

34,00 €

Explore FDA medical-device recall enforcement reports in a versioned quarterly archive with source classifications and evidence.

Purchase terms

Your purchase includes the edition described on this page. Later releases are separate unless this offer explicitly includes an update entitlement.

Source checks and new-release publication do not change the historical coverage or automatically add future editions to an earlier purchase.

Edition details

Edition
zf-025-2026-q3-f90d4585599f
Files
CHANGELOG.md, LICENSE.md, README.md, REFUND.md, SUPPORT.md, artifacts/changelog-CHANGELOG.md, artifacts/checksums-checksums.json, artifacts/data-dictionary-DATA-DICTIONARY.md, artifacts/full-full.csv, artifacts/full-full.jsonl, artifacts/full-full.parquet, artifacts/known-limitations-KNOWN-LIMITATIONS.md, artifacts/license-LICENSE.md, artifacts/manifest-manifest.json, artifacts/provenance-provenance.json, artifacts/quality-report-quality-report.json, artifacts/readme-README.md, artifacts/sample-sample.csv, artifacts/schema-schema.json, artifacts/source-policy-source-policy.json, checksums.json, cover.svg, download-manifest.json, gumroad-product.json, health-check.json, output-contract.json, quality-manifest.json, rollback.json, sample-data.json, smoke-fixture.json
Formats
CSV, JSON, JSONL, MD, PARQUET, SVG
Coverage
Immutable normalized edition of current-quarter FDA medical-device recall enforcement reports with classification, firm, product, reason, distribution, and first-party evidence fields.
Geographic scope
Immutable normalized edition of current-quarter FDA medical-device recall enforcement reports with classification, firm, product, reason, distribution, and first-party evidence fields.
Publisher
openFDA Medical Device Recall Enforcement Reports
Source updated
Explicitly unknown; see immutable provenance for the recorded source retrieval.
Source checked
2026-07-21T15:52:06+02:00
Released
2026-07-21T15:52:06+02:00
Licence and attribution
# Marketplace licence Use is governed by the licence and terms shown on the canonical marketplace listing. Source provenance and third-party source rights remain attached to delivered artifacts. No custom or negotiated licence is implied.

View the publisher source

Schema

FieldTypeDescription
recall_numberstring
report_datestring
recall_initiation_datestring
classificationstring
statusstring
recalling_firmstring
product_descriptionstring
reason_for_recallstring
product_quantitystring
distribution_patternstring
voluntary_mandatedstring
countrystring
statestring
source_urlstring

Sample preview

Open the public sample

classificationcountrydistribution_patternproduct_descriptionproduct_quantityreason_for_recallrecall_initiation_daterecall_numberrecalling_firmreport_datesource_urlstatestatusvoluntary_mandated
Deterministic fixture Classification for FDA Medical Device Recall Enforcement Quarterly ArchiveDeterministic fixture Country for FDA Medical Device Recall Enforcement Quarterly ArchiveDeterministic fixture Distribution Pattern for FDA Medical Device Recall Enforcement Quarterly ArchiveDeterministic fixture Product Description for FDA Medical Device Recall Enforcement Quarterly ArchiveDeterministic fixture Product Quantity for FDA Medical Device Recall Enforcement Quarterly ArchiveDeterministic fixture Reason For Recall for FDA Medical Device Recall Enforcement Quarterly ArchiveDeterministic fixture Recall Initiation Date for FDA Medical Device Recall Enforcement Quarterly ArchiveDeterministic fixture Recall Number for FDA Medical Device Recall Enforcement Quarterly ArchiveDeterministic fixture Recalling Firm for FDA Medical Device Recall Enforcement Quarterly ArchiveDeterministic fixture Report Date for FDA Medical Device Recall Enforcement Quarterly Archivehttps://api.fda.gov/device/enforcement.jsonDeterministic fixture State for FDA Medical Device Recall Enforcement Quarterly Archivefixture_validatedDeterministic fixture Voluntary Mandated for FDA Medical Device Recall Enforcement Quarterly Archive
Deterministic fixture Classification for FDA Medical Device Recall Enforcement Quarterly Archive 2Deterministic fixture Country for FDA Medical Device Recall Enforcement Quarterly Archive 2Deterministic fixture Distribution Pattern for FDA Medical Device Recall Enforcement Quarterly Archive 2Deterministic fixture Product Description for FDA Medical Device Recall Enforcement Quarterly Archive 2Deterministic fixture Product Quantity for FDA Medical Device Recall Enforcement Quarterly Archive 2Deterministic fixture Reason For Recall for FDA Medical Device Recall Enforcement Quarterly Archive 2Deterministic fixture Recall Initiation Date for FDA Medical Device Recall Enforcement Quarterly Archive 2Deterministic fixture Recall Number for FDA Medical Device Recall Enforcement Quarterly Archive 2Deterministic fixture Recalling Firm for FDA Medical Device Recall Enforcement Quarterly Archive 2Deterministic fixture Report Date for FDA Medical Device Recall Enforcement Quarterly Archive 2https://api.fda.gov/device/enforcement.json 2Deterministic fixture State for FDA Medical Device Recall Enforcement Quarterly Archive 2fixture_validated 2Deterministic fixture Voluntary Mandated for FDA Medical Device Recall Enforcement Quarterly Archive 2
Deterministic fixture Classification for FDA Medical Device Recall Enforcement Quarterly Archive 3Deterministic fixture Country for FDA Medical Device Recall Enforcement Quarterly Archive 3Deterministic fixture Distribution Pattern for FDA Medical Device Recall Enforcement Quarterly Archive 3Deterministic fixture Product Description for FDA Medical Device Recall Enforcement Quarterly Archive 3Deterministic fixture Product Quantity for FDA Medical Device Recall Enforcement Quarterly Archive 3Deterministic fixture Reason For Recall for FDA Medical Device Recall Enforcement Quarterly Archive 3Deterministic fixture Recall Initiation Date for FDA Medical Device Recall Enforcement Quarterly Archive 3Deterministic fixture Recall Number for FDA Medical Device Recall Enforcement Quarterly Archive 3Deterministic fixture Recalling Firm for FDA Medical Device Recall Enforcement Quarterly Archive 3Deterministic fixture Report Date for FDA Medical Device Recall Enforcement Quarterly Archive 3https://api.fda.gov/device/enforcement.json 3Deterministic fixture State for FDA Medical Device Recall Enforcement Quarterly Archive 3fixture_validated 3Deterministic fixture Voluntary Mandated for FDA Medical Device Recall Enforcement Quarterly Archive 3
Deterministic fixture Classification for FDA Medical Device Recall Enforcement Quarterly Archive 4Deterministic fixture Country for FDA Medical Device Recall Enforcement Quarterly Archive 4Deterministic fixture Distribution Pattern for FDA Medical Device Recall Enforcement Quarterly Archive 4Deterministic fixture Product Description for FDA Medical Device Recall Enforcement Quarterly Archive 4Deterministic fixture Product Quantity for FDA Medical Device Recall Enforcement Quarterly Archive 4Deterministic fixture Reason For Recall for FDA Medical Device Recall Enforcement Quarterly Archive 4Deterministic fixture Recall Initiation Date for FDA Medical Device Recall Enforcement Quarterly Archive 4Deterministic fixture Recall Number for FDA Medical Device Recall Enforcement Quarterly Archive 4Deterministic fixture Recalling Firm for FDA Medical Device Recall Enforcement Quarterly Archive 4Deterministic fixture Report Date for FDA Medical Device Recall Enforcement Quarterly Archive 4https://api.fda.gov/device/enforcement.json 4Deterministic fixture State for FDA Medical Device Recall Enforcement Quarterly Archive 4fixture_validated 4Deterministic fixture Voluntary Mandated for FDA Medical Device Recall Enforcement Quarterly Archive 4
Deterministic fixture Classification for FDA Medical Device Recall Enforcement Quarterly Archive 5Deterministic fixture Country for FDA Medical Device Recall Enforcement Quarterly Archive 5Deterministic fixture Distribution Pattern for FDA Medical Device Recall Enforcement Quarterly Archive 5Deterministic fixture Product Description for FDA Medical Device Recall Enforcement Quarterly Archive 5Deterministic fixture Product Quantity for FDA Medical Device Recall Enforcement Quarterly Archive 5Deterministic fixture Reason For Recall for FDA Medical Device Recall Enforcement Quarterly Archive 5Deterministic fixture Recall Initiation Date for FDA Medical Device Recall Enforcement Quarterly Archive 5Deterministic fixture Recall Number for FDA Medical Device Recall Enforcement Quarterly Archive 5Deterministic fixture Recalling Firm for FDA Medical Device Recall Enforcement Quarterly Archive 5Deterministic fixture Report Date for FDA Medical Device Recall Enforcement Quarterly Archive 5https://api.fda.gov/device/enforcement.json 5Deterministic fixture State for FDA Medical Device Recall Enforcement Quarterly Archive 5fixture_validated 5Deterministic fixture Voluntary Mandated for FDA Medical Device Recall Enforcement Quarterly Archive 5
Category:

Review the medical-device recall enforcement reports captured for the archive’s stated quarter. The release keeps classification, firm, product, reason and distribution information together so the record can be understood in its original reporting context.

What this download contains

This is a device recall archive, not an adverse-event database, product approval list or individual-device assessment. If the quarter is still open, the release is explicitly quarter-to-date. Source terminology and relevant dates should remain visible in any derived report.

Working with this edition

Load the documented fields and inspect representative rows before making aggregations. Use source references to investigate a report and compare editions only when their filters and reporting periods are compatible.

Product questions

Does this include all medical-device incident reports?

No. Recall enforcement and adverse-event reporting are different datasets.

Does a missing device mean there is no recall?

No. Absence from a period-specific extract is not a safety clearance or an exhaustive current recall check.

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