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Reference Libraries

openFDA Device Enforcement API Documentation Dataset

openFDA Device Enforcement API Documentation Dataset

19,00 €

Keep openFDA device-enforcement API reference sections in a structured offline dataset, distinct from the recall records themselves.

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-034-2026-09-05-972f49a0e18c
Files
data/full.jsonl, data/full.csv, data/sample.json, schema.json, provenance.json, manifest.json, quality-report.json, LICENSE.md, README.md, CHANGELOG.md, sources/original-document.html, checksums.json
Formats
CSV, HTML, JSON, JSONL, MD
Coverage
Structured documentation snapshot of openFDA device enforcement docs, retrieved 2026-09-05. Records are document sections and paragraphs; the original publisher HTML is included.
Geographic scope
Structured documentation snapshot of openFDA device enforcement docs, retrieved 2026-09-05. Records are document sections and paragraphs; the original publisher HTML is included.
Publisher
open.fda.gov
Source updated
Explicitly unknown; see immutable provenance for the recorded source retrieval.
Source checked
2026-09-05T12:07:45.426063+00:00
Released
2026-09-05T12:07:45.426063+00:00
Licence and attribution
Source records remain subject to the original publisher terms linked in provenance.json. Retain attribution and source notices. Zentra grants use of the normalization, schema and packaging for internal and commercial analysis; this does not grant exclusive rights over public source facts or third-party material. No endorsement by source publishers.

View the publisher source

Schema

FieldTypeDescription
elementstring
sectionstring
section_record_idinteger
source_urlstring
textstring

Sample preview

Open the public sample

elementsectionsection_record_idsource_urltext
pDevice Enforcement Overview1https://open.fda.gov/apis/device/enforcement/The openFDA device enforcement reports API returns data from the FDA Recall Enterprise System (RES), a database that contains information on recall event information submitted to FDA. Currently, this data covers publicly releasable records from 2004-present. The data is updated weekly.
pDevice Enforcement Overview2https://open.fda.gov/apis/device/enforcement/The procedures followed to input recall information into RES when FDA learns of a recall event are outlined in Chapter 7 of FDA’s Regulatory Procedure Manual. The Regulatory Procedures Manual is a reference manual for FDA personnel. It provides FDA personnel with information on internal procedures to be used in processing domestic and import regulatory and enforcement matters.
liKey Facts3https://open.fda.gov/apis/device/enforcement/Source of the data:FDA Recall Enterprise System (RES)
liKey Facts4https://open.fda.gov/apis/device/enforcement/Changes to the source data:openFDA annotates the original records with special fields and converts the data into JSON, which is a widely used machine readable format.
liKey Facts5https://open.fda.gov/apis/device/enforcement/Time period covered in this API:2004 to null
h3Additional Information About Medical Device Recall Enforcement Reports6https://open.fda.gov/apis/device/enforcement/Additional Information About Medical Device Recall Enforcement Reports
pAdditional Information About Medical Device Recall Enforcement Reports7https://open.fda.gov/apis/device/enforcement/Recalls are an appropriate alternative method for removing or correcting marketed consumer products, their labeling, and/or promotional literature that violate the laws administered by the Food and Drug Administration (FDA). Recalls afford equal consumer protection but generally are more efficient and timely than formal administrative or civil actions, especially when the product has been widely distributed.
pAdditional Information About Medical Device Recall Enforcement Reports8https://open.fda.gov/apis/device/enforcement/Manufacturers and/or distributors may initiate a recall at any time to fulfill their responsibility to protect the public health from products that present a risk of injury or gross deception, or are otherwise defective. Firms may also initiate a recall following notification of a problem by FDA or a state agency, in response to a formal request by FDA, or as ordered by FDA.
Category:

Use a focused documentation extract when planning or maintaining an integration with the device-enforcement API. The product turns the selected reference sections into structured text that can be reviewed or indexed with its source context.

What this download contains

The records describe documentation, not recalled devices. That distinction matters when choosing between a reference pack and a data export: this product helps you understand a service, while the separate enforcement dataset provides captured source records.

Working with this edition

Check the section inventory and sample, then add the text to your internal documentation workflow. Refer to the current official API documentation when implementing a live request or interpreting an updated response contract.

Product questions

Are device recall rows included?

No. This is the documentation product; the recall-record export is a separate offer.

Does it include an API key?

No. It is reference material, not an access credential or hosted API subscription.

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