Ethicon is the manufacturer of surgical staples used in procedures such as gastric bypass surgery. A staple recall occurs when a medical device is deemed to have significant risks of serious or even fatal consequences if it is used. A staple recall can involve any part of the manufacturing process from raw materials to finished products. Lines, sutures, and other staples are commonplace tools in surgical practices due to their ability to quickly and cleanly close wounds. All three types of staples are utilized for almost every type of procedure. When a stapler fails, there may be serious consequences for the patient if the wound does not heal properly. This article details everything you need to know about Ethicon’s surgical staple recall, including frequently asked questions, what you should do if you have specific products, and an Ethicon Surgical Staples Lawsuit.
What is the Ethicon Surgical Staple Recall?
Ethicon is conducting a surgical staple recall due to a potential failure of certain surgical staples it manufactures. This fault can cause failure to properly close a wound, leading to an increased risk of infection, scarring, and the potential need for additional surgery. It is important to note that no specific product is inherently defective. Rather, certain lots of surgical staples with specific manufacturing dates may fail at a greater rate than others.
Why is Ethicon Conducting a Staple Recall?
Ethicon discovered that some surgical staples manufactured at two of their plants have a greater than expected failure rate. Ethicon reported this information to the U.S. Food and Drug Administration (FDA) as required by law. As a result of this discovery, Ethicon decided to conduct a surgical staple recall. While Ethicon believes the likely risk of injury is low for these products, it is not worth the risk for patients. Ethicon is conducting a surgical staple recall to minimize any potential risks associated with these products.
Which Products Are Part of the Ethicon Surgical Staple Recall?
On Oct. 30, 2019, the FDA announced the Class 1 recall of Ethicon’s Echelon Flex Endopath staplers. The FDA recall, initiated by the Johnson & Johnson subsidiary earlier in October, includes a variety of products, such as the following
What are the Risks Associated with These Products?
Ethicon has reported that certain lots of surgical staples manufactured at two of their plants have a greater than expected failure rate. The company has not yet determined why these products are failing at a higher rate than expected. Patients who receive any of the recalled products listed above may experience delayed healing and increased risk for infection, wound dehiscence, and the need for additional surgery. These products are made from stainless steel. Stainless steel is a common and safe material for surgical staples. However, Ethicon may have created these products with defects.
What Should You Do if You Have These Products?
If you have any of the three types of products listed in the Ethicon surgical staple recall, your doctor will recommend a different type of closure. If you have any of these products, you should not return them to a pharmacy or discard them. Instead, you should store them in a safe place until your doctor tells you what to do with them. Ideally, these products should be kept in their original packaging. If you have any of these products, you should call the manufacturer’s patient hotline at 833-355-3395 to check the status of your specific product. The company will work with you to determine what to do with your product.
Surgical staples are a common tool in surgical practices due to their ability to quickly and cleanly close wounds. However, all staples, including those manufactured by Ethicon, are capable of failing. If you needed corrective surgery due to complications from staples in surgery, you probably meet the Ethicon lawsuit criteria, so contact Ethicon Recall Lawyer Timothy L. Miles today at 855/846-6529 or submit the contact form here, and see if you qualify for an Ethicon Surgical Staples Lawsuit.
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