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FDA Class 1 Recall of J&J/Ethicon Surgical Staplers


The FDA has issued a Class I Recall for surgical staplers made by Johnson & Johnson’s Ethicon unit. Surgical staplers are devices used for tissue closure. Surgical staplers are an alternative to nylon sutures because surgical staples tend to cause less inflammation and reduced surgical procedure time.

FDA Issues Safety Recall to Medical Providers

The FDA has recalled the Echelon Flex Endopath stapler because the stapler can produce misshapen staples that do not correctly close incisions. Class I recalls are issued when there is risk of serious injury or death. The FDA has received reports of 1 death and 7 serious injuries associated with the surgical stapler product line.

Injuries Associated with Ethicon Surgical Stapler/Staples

The injuries were largely caused by surgical staplers that do not correctly close incisions.

When a malfunction happens, the FDA warns that patients can suffer from:

  • Post-operative connection leaks
  • Hemorrhage
  • Hemorrhagic shock
  • Need for additional surgeries
  • Death

Contact Brett Oppenheimer, Attorney with your Potential Surgical Stapler Injury Claim

Surgical staplers and surgical staples are commonly used in a variety of medical procedures. Many victims of faulty staplers have already filed lawsuits against the manufacturers, and a number of them have gone to trial and received jury verdicts in their favor, or reached a settlement with the manufacturers.

Contact an attorney if you feel you have been injured as the result of a faulty surgical stapler or faulty staples. An attorney can help you identify if your injury is related to a faulty device, and if so, work to compensate you for your damages. Brett H. Oppenheimer is an attorney who has experience in holding medical device companies accountable for their defective products.

Make an appointment with Brett today by calling (502) 242-8877 or by filling out the contact form on this page.

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