PDA

View Full Version : FDA Announces Class I Recalls of Two Unapproved Devices


News Reader
12-15-2008, 09:04 PM
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.

More... (http://www.fda.gov/bbs/topics/NEWS/2008/NEW01925.html)