Track Class 1
FDA-Issued Warnings, Bans, or Recalls

Medical devices continue to be subject to any warnings, bans, or recalls issued by the FDA. The FDA does track some medical devices from the manufacturer to the consumer in order to notify consumers and recall devices should a device pose a serious health risk. The FDA does not track medical devices intended for repeated use, often the devices used by reutilization programs. Exchange Programs should encourage consumers to verify whether the devices they may be acquiring are subject to any FDA recalls or bans at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTopic/medicaldevicesafety/recalls.cfm.

Exchange programs should have a mechanism for removing medical devices from their listings if notified that the listed product is recalled or banned.