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01-21-2009, 08:40 AM #1
FDA Announces Class I Recalls of Two Unapproved Devices (December 15)
The U.S. Food and Drug Administration (FDA) announced a Class 1 recall today for two unapproved and uncleared devices whose manufacturers claimed could treat various medical conditions. A Class 1 recall means that there is a reasonable probability that the use of a device will cause adverse health consequences or death.