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Balloon Catheter Recalled due to Bursting.

By Burg Simpson

Balloon Catheter Recalled due to Bursting. On June 18, 2019, the FDA reported that Cook Incorporated has recalled a balloon catheter, the Advance Enforcer 35 Focal-Force PTA Balloon Catheter 6mm x 4cm.  This catheter is used to open blocked or narrowed arteries that supply blood to the leg. What are balloon catheters? Balloon catheters are… Read more »

DePuy Synthes Elbow Implant Recall

By Burg Simpson

On December 29, 2016, DePuy issued a recall for over 50,000 elbow joint replacement devices known as the “DePuy Synthes Radial Head Prosthesis System.” The company reported that the device’s radial stem, which attaches the device to the lower arm, may loosen after surgery. If loosening occurs the device may not function properly and can… Read more »

FDA Announces Recall of Hyland’s Homeopathic Teething Tablets

By Burg Simpson

On April 13, 2017 the U.S. Food and Drug Administration (“FDA”) announced the recall of all lots of Hyland’s Baby Teething Tablets and Hyland’s Baby Nighttime Teething Tablets by the manufacturer, Standard Homeopathic Company. This recall follows the FDA’s September 2016 warning against the use of homeopathic teething products. At that time the FDA stated… Read more »

Dangerous Ingredient in Xanthium & Siler Combo (Bi Yan Pian) Dietary Supplements Leads to Recall

By Burg Simpson

On February 7, 2017, Kingsway Trading Inc. issued a recall of Xanthium & Siler Combo (Bi Yan Pian) Dietary Supplement because it contains an ingredient, Ephedra Herba (ma huang), that was not disclosed in the supplement’s ingredients list and that has been banned by FDA. Bi Yan Pian, sometimes called “Nose Inflammation Pills,” are often… Read more »

FDA Issues Class 1 Recall of Stryker OASYS Midline Occiput Plate Used in Spinal Surgery

By Burg Simpson

On August 29, 2013, Stryker issued a recall of a device used in spinal surgery and the FDA designated the recall as a Class 1 recall, warning that the device failure could result in serious injury or death. At issue is the OASYS Midline Occiput Plate, which is part of the OASYS Occipito Cervico Thoracic… Read more »

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