Zentra Foundry · verified digital download

FDA Medical Device Recall Enforcement Quarterly Archive

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FDA Medical Device Recall Enforcement Quarterly Archive is a versioned Zentra Foundry digital download. Delivery is an immediate Gumroad download after a successful one-time purchase. No Zentra subscription or customer API account is required.

What it is

Immutable normalized edition of current-quarter FDA medical-device recall enforcement reports with classification, firm, product, reason, distribution, and first-party evidence fields. This is a reference archive, not an alerting service.

Who it is for

What you get

One immutable ZIP for this edition, including:

Update cadence: Snapshot-driven.

A labelled sample and schema preview are available on the Foundry product page before purchase.

Schema fields

Source and provenance

Limitations

Foundry page, support, refunds

FDA Medical Device Recall Enforcement Quarterly Archive

Outcome

Immutable normalized edition of current-quarter FDA medical-device recall enforcement reports with classification, firm, product, reason, distribution, and first-party evidence fie

Problem solved

  • Immutable normalized edition of current-quarter FDA medical-device recall enforcement reports with classification, firm, product, reason, distribution, and first-party evidence fie

Who it is for

Procurement, safety, data-quality, marketplace, and AI assurance teams requiring auditable fixed evidence.

Exact contents

  • 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
  • download-manifest.json
  • gumroad-product.json
  • health-check.json
  • output-contract.json

Inputs and outputs

Inputs

  • Inspect README.md, output-contract.json, and checksums.json before using the fixed download.
  • No credential, account, or hosted Zentra service is included in this archive.

Outputs

  • A versioned fixed download with documented output fields: recall_number, report_date, recall_initiation_date, classification, status, recalling_firm, product_description, reason_for_recall, product_quantity, distribution_pattern, voluntary_mandated, country, state, source_url.
  • sample-data.json documents the delivered format; it is not presented as captured runtime output.

Formats

  • ZIP
  • Markdown
  • JSON
  • CSV
  • JSONL
  • Parquet

How it works

  1. Read README.md, LICENSE.md, SUPPORT.md, and REFUND.md before use.
  2. Verify the archive with checksums.json.
  3. Inspect output-contract.json and sample-data.json to understand the documented delivered format.

Compatibility and requirements

  • Use software compatible with the documented files in this immutable fixed download.

Dataset contract and scope

  • Documented delivered-record count: 25.
  • Documented snapshot date: 2026-07-21.
  • Documented fields: recall_number, report_date, recall_initiation_date, classification, status, recalling_firm, product_description, reason_for_recall, product_quantity, distribution_pattern, voluntary_mandated, country, state, source_url.
  • Documented source labels: openFDA Medical Device Recall Enforcement Reports, Zentra prepared product artifact.

Documented sample or preview

  • sample-data.json is a documented archive preview and is not presented as a captured runtime output.

Source provenance and freshness

  • openFDA Medical Device Recall Enforcement Reports — Unless otherwise noted, openFDA data is public domain and dedicated under CC0 1.0. This edition excludes the nested openfda annotation and GMDN content. — Unless otherwise noted, openFDA data is public domain and dedicated under CC0 1.0. This edition excludes the nested openfda annotation and GMDN content. — Declared source reference: https://api.fda.gov/device/enforcement.json
  • Zentra prepared product artifact — Zentra-owned product metadata generated inside the application until an approved route-specific public source is attached.

quarterly_fixed_edition

Version and last verification

Version 2026-Q3.f90d4585599f

Last verified 2026-08-26T16:22:55+02:00

License and permitted use

Use is limited to the rights expressly stated in LICENSE.md in the immutable downloaded archive; this listing grants no additional rights.

Update policy

This is an immutable, versioned fixed download. The archive does not state an automatic update entitlement.

Limitations

  • Do not imply completeness, legal advice, observed customer behavior, or guaranteed commercial outcomes.
  • No third-party redistribution restriction detected for prepared metadata-only artifacts.
  • The edition contains current-quarter records returned by the bounded openFDA query at capture time; it is not a complete recall universe or public alert service.
  • FDA states that enforcement-report status is not a recall lifecycle tracker and may remain unchanged after classification.
  • The records are unvalidated public evidence and must not be used for medical, legal, or regulatory decisions; consult FDA and a qualified professional.
  • The nested openfda annotation is excluded so this edition does not redistribute GMDN or other separately licensed annotation content.

Product-specific FAQ

Is this a recurring hosted Zentra service?
No. The download manifest identifies this as an immutable, one-time fixed download.
Does the archive include credentials or buyer-account access?
No. The buyer documentation states that credentials and external accounts are not included.

Related products and bundle path

    Support boundary

    Support is limited to the fixed download and the documentation described in SUPPORT.md; buyers retain responsibility for their own tools, accounts, and decisions.