The U.S. Food and Drug Administration has issued a Class 1 recall, the strictest form of recall, for a Johnson & Johnson surgical product. Nearly 95,000 surgical staplers made by Johnson & Johnson’s Ethicon unit have been labeled under a Class 1 recall, meaning the devices may cause serious injury or death. Ethicon has confirmed at least two serious injuries related to the product.
These staplers are used during gastrointestinal procedures to create anastomoses and are regulated as Class I medical devices, not requiring a pre-market submission to the FDA. The staplers may insufficiently fire, compromising staple line integrity. The company has instructed device owners to cease use and return affected devices.
Johnson and Johnson has marketed several products both to doctors and the public that have resulted in recalls and/or lawsuits, such as talcum powder, certain hip replacements, and transvaginal and hernia mesh implants, among others. If you have been injured by a medical device or other product, contact the lawyers at The Ruth Law Team for a free consultation. We can be reached at 888-783-8378.