FDA Recalls

FDA RecallsRecalls 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

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 removal surgery.  To qualify, the female must have undergone a surgery in which the procedure included the use of a morcellator, a power device used to cut the uterine…

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 way to remove tissue or cells out of the body without having to perform the procedure by entering abdominally or vaginally.  During a laparoscopic hysterectomy, a mechanical morcellator is…

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 some of its Gynecare Women’s Health Mesh products. Although this Ethicon mesh recall was voluntary and not mandated by the FDA, Johnson & Johnson will also case to commercialize…

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 return any product in their possession from the October 21, 2010 recall. Consumers with Actavis 25 mcg/h Fentanyl patches may call 1-877-422-7452 (24 hours/day, 7 days/week) for return instructions…

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 a potential for the device to unexpectedly: Power Off then On by itself. Power Off then NOT turn On. Power Off by itself requiring the operator to turn it…

Operating Room System II Surgical Navigation System Recall

Stryker and FDA notified healthcare professionals of a recall of 23 Operating Room System II Surgical Navigation Systems because there is a potential for the navigation PC SPC-1 component to stop working which could result in the screen freezing, the system updating at a slow rate, or not responding at all. The Navigation System II is…

Cardiovascular Systems ViperSheath Sheath Introducer Recall

Cardiovascular Systems, Inc. and FDA notified healthcare professionals of a nationwide recall of all lots of the ViperSheath Sheath Introducer on behalf of Thomas Medical due to reports about stretching or fracture of the sheath during use. In the event of a device fracture, separated segments of the device may require unplanned open surgery to…

Ti Synex II Vertebral Body Replacement Recall

FDA notified healthcare professionals of a Class I Recall of all lots of the Synthes USA, Ti Synex II Vertebral Body Replacement, a device used in the T1-L5 portion of the spine to replace a collapsed, damaged, or unstable vertebral body. Reports of moderate to severe loss of vertebral body replacement height (caused by failure…

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 off the aorta, monitors aortic pressure, and delivers solution to stop the heart during cardiopulmonary bypass procedures. The recall was initiated because the balloon catheters may spontaneously rupture during…

Premie Pack and Meconium Pack Recall

Centurion Medical Products and FDA notified healthcare professionals about a Class I recall of Premie Pack, Kit Code LM 110 and Full Term Meconium Pack, Kit Code LM115. The pediatric tracheal tubes used in these kits were manufactured with an internal diameter smaller than indicated on the label, which could result in an inability to remove secretions…