FDA Sends C.R. Bard a Stern Warning for Unapproved Devices

7/23/2015 Los Angeles Food and Drug Administration (FDA) compliance officer Dr. Raymond W. Brullo issued a scathing warning letter to Thomas Ring, the CEO of New Jersey-based device manufacturer C.R. Bard. The letter contained a litany of violations regarding several single-use devices for IVC and foreign body retrieval. The letter follows a series of inspections


Ikea Issues Recall for 27 Million Dressers after Deaths of Two Children

7/23/2015 Ikea, the Swedish furniture icon, along with the Consumer Product Safety Commission (CPSC), has recalled seven million dressers from its popular Malm collection, along with 20 million other dressers and chests of drawers following the deaths of two children who were crushed in 2014. Although technically considered a recall, the CPSC and the company’s


NHTSA, General Motors both Score Huge Victories in Congress

7/20/2015 Auto safety became political last week  on Capitol Hill as lawmakers debated a series of attachments to a transportation bill to be presented next month. Much of the debate went along partisan lines, with the Republican majority blocking several key measures surrounding the massive auto recall epidemic that has plagued the industry over the


NHTSA Deputy Administrator Friedman Leaves Agency for Energy Department Post

7/17/2015 Deputy administrator David Friedman, who oversaw the National Highway Transportation Safety Administration (NHTSA) through the majority of its most challenging year ever, left the agency on Friday to take a position at the U.S. Energy Department. Former NHTSA head David Strickland left the agency in January 2014 to join Venable LLP, a law firm


‘Et tu Prius?’ Toyota Issues another Recall

7/16/2015 On Wednesday, Toyota announced that it was recalling over 625,000 hybrid vehicles, the large majority of them Prius models, due to a flaw in the software that controls the power converter. The defect could cause the vehicles to shut down and come to a complete stop. The recall affects the Prius V wagon/minivan, which


FDA to Review Birth Control Device Essure due to Side Effect Concern

The U.S. Food and Drug Administration (FDA) is joining famous environmental and consumer activist Erin Brockovich in its skepticism of Bayer’s popular birth control device, Essure. Bayer claims that the coil-like device is the only non-surgical permanent form of birth control on the market. The FDA announced last month that it will be conducting a


Takata Says no to Victims’ Compensation Fund

7/12/2015 Embattled Japanese airbag manufacturer Takata has roiled some lawmakers by announcing that the company will not set up a victim’s compensation fund similar to that for the General Motors’ ignition switch recall. Takata’s North American senior vice-president Kevin Kennedy made the announcement in a letter penned to Senator Richard Blumenthal (D-CT), who had strongly


NHTSA Releases Takata Airbag Recall List, More Honda, GM Recalls Announced

7/10/2015 It’s been a busy 48 hours for National Highway Transportation Safety Administration (NHTSA) chief Michael Rosekind. On Wednesday, the agency released the list of vehicles affected by the massive Takata airbag recall. In addition to the list that is published at the end of this posting, the NHTSA has created a vehicle identification number


NHTSA Announces in Safety Hearing that Fiat-Chrysler will be sanctioned for Recalls

7/5/2015 For the first time in nearly three years, the National Highway Transportation Safety Administration (NHTSA) conducted a public hearing on Thursday, July 2nd. In the hearing, the agency scrutinized Fiat-Chrysler’s handling of 23 recalls involving 11 million vehicles. Acting director of the agency’s Office of Defects Investigation (ODI), Jennifer Timian, began the hearing by