FDA notified healthcare professionals of a Class I recall of certain LIFEPAK CR Plus Automated External Defibrillators (AED) manufactured and distributed from July 9, 2008 through August 19, 2008. An extremely humid environment may cause the affected devices to improperly analyze the heart rhythm and may cause the device to delay or fail to deliver … [Read more...]

Arbonne International, LLC ("Arbonne") has voluntarily recalled one lot of its Seasource Detox Spa® Foaming Sea Salt Scrub. The recalled products were manufactured by a third party and distributed nationwide through Arbonne Independent Consultants. The product comes in a 6.8 fluid oz white tube and is identified with a lot number on the crimping at … [Read more...]

Smiths Medical announced that it is initiating a nationwide voluntary recall of Portex® Uncuffed Pediatric-Sized Tracheal Tubes (sizes 2.5, 3.0 and 3.5 mm) manufactured before September 2009. Description of the Issue A small number of tubes were manufactured with internal diameters slightly smaller than indicated on the labeling, which may create … [Read more...]

CONTACT: CONMED Corporation Robert Shallish Chief Financial Officer 315-624-3206 - PRODUCTS INCLUDED IN THE RECALL: * PRO5 and PRO6 Series Handpieces Manufactured and Distributed Prior to May 31, 2008 * MC5057 Universal Cable Manufactured and Distributed Prior to December 1, 2006 CONMED Corporation's (Nasdaq: CNMD) CONMED Linvatec unit announced … [Read more...]

Penumbra and FDA notified healthcare professionals of the Class 1 recall of the Neuron 5F Select Catheter, used to remove blood clots or foreign objects from blood vessels. Due to a manufacturing error, the catheters may contain pin holes and exposed wire braids which may result in a brain clot or a blood vessel puncture, and this may lead to … [Read more...]