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Medical Device Recalls
WHAT: Manufacturer takes a correction or removal action for medical device problem. FDA reviews strategy, assesses health hazard, violatiion of law, assigns classification
  • Class I: Reasonable chance to cause serious health problems or death
  • Class II: May cause temporary/reversible health problem
  • Class III: Not likely to cause health problem or injury
WHY:

  • Inspecting for problems
  • Repairing device
  • Adjusting settings
  • Re-labeling
  • Destroying
  • Notifying patients of problem
  • Monitoring patients for health issues

WHO: Company (voluntarily) or by FDA

HOW: FDA notifies public
recall database.JPG

Searchable Database

  • Recalls since Nov 2002
  • Beginning Jan 2017, includes correction or removal actions prior to recall classification

LINK


api
Downloads [/device/recall]
  • OpenFDA is Elasticsearch-based API that serves public FDA data
  • Zipped JSON files
  • Records in same format as API calls to endpoint

LINK


 

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