I notice there are two types of recall datasets: Recall Enforcement Report and Recall Report. And I downloaded both of them. There are overlaps of recall events and related information, but they are definitely not the same. Could someone advise what's the difference between these two datasets? Which one if more accurate and up to date?
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1 Answer
Recalls and Recall Enforcement Reports are different datasets and serve slightly different purposes. Both datasets get updated on openFDA on a regular basis.
What is a Recall:
The FDA uses the term “recall” when a manufacturer takes a correction or removal action to address a problem with a medical device that violates FDA law. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.
What is an Enforcement Report:
After a recall has been classified, the FDA notifies the public in the weekly Enforcement Report. However, in some cases, a recall may be listed prior to classification when FDA determines the firm’s removal or correction of a marketed product(s) meets the definition of a recall.
The openFDA medical device recalls dataset gets updated monthly based on data from the FDA medical device recall database at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm.
The openFDA medical device recall enforcement report dataset gets updated weekly based on data from https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/enforcement-reports.
