Recalls are actions taken by a company to remove a product from the market. Recalls may be conducted on a company’s own initiative, by FDA request, or by FDA order under statutory authority. A Class I recall is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. A Class II recall is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. A Class III recall is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

A market withdrawal occurs when a product has a minor violation that would not be subject to FDA legal action. The company removes the product from the market or corrects the violation. For example, a product removed from the market due to tampering, without evidence of manufacturing or distribution problems, would be a market withdrawal.

Most Recent FDA Recalls

August 8, 2014

Uterine Leiomyosarcoma from Morcellator Device

Unforeseen Cancer Development After Morcellation Financial compensation may be available to females who have been diagnosed with uterine leiomyosarcoma following a laparoscopic hysterectomy or uterine fibroid […]
August 7, 2014

Johnson and Johnson (J&J) Morcellator Recall

 Morcellators Recalled by Manufacturer Johnson and Johnson (J&J) A morcellator is a laparoscopic power device used in fibroid and hysterectomy surgeries. Laparoscopic surgeries are an innovative […]
October 25, 2012

Ethicon Mesh Recall

In June of 2012, the Ethicon, Inc. division of Johnson & Johnson notified the US Food and Drug Administration that it would no longer be offering […]
November 4, 2010

Actavis Fentanyl Patch Recall

Morristown, NJ – Further to its previously announced voluntary recall of 18 lots of Fentanyl Transdermal System 25 mcg/hour C-II patches, Actavis is encouraging consumers to […]
April 23, 2010

LIFEPAK 15 Defibrillator Recall

FDA notified healthcare professionals of a Class I recall of LIFEPAK 15 Monitor/Defibrillator manufactured and distributed between March 26, 2009 and December 15, 2009. There is […]
November 9, 2009

CardioVations EndoClamp Aortic Catheter Recall

FDA and Edwards Lifesciences notified healthcare professionals about the Class 1 recall of CardioVations EndoClamp Aortic Catheter, Model Numbers EC1001 and EC65, a device that blocks […]