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FDA Announces a Class 1 Recall of Defective Johnson & Johnson Surgical Staplers

May 23, 2019 in

Johnson & Johnson unit Ethicon has recalled its Endo-Surgery Curved Intraluminal Stapler with Adjustable Height Staples due to a defect that may result in potential failure and misfiring. The U.S. The Food and Drug Administration (FDA) has labeled the recall as Class 1, the most serious possible recall. Here, the product liability attorneys at Sullivan, Papain, Block, McGrath & Cannavo P.C. detail the most recent findings surrounding the recall of Johnson & Johnson’s surgical staplers.

FDA Labels the Recall as Most Severe

Early April 2019, Ethicon recalled 92,496 surgical staplers in a Class 1 recall, the FDA’s most serious recall. Class 1 recalls are typically issued for products or devices that have defects that could potentially result in serious injury or death. The defects found in the surgical staplers, which are used by surgeons during gastrointestinal procedures, have been linked to total staple line failure and insufficient firing during surgery.

Defect in Surgical Staplers Results in Serious Injuries

Ethicon has confirmed that a defect in the surgical staplers can cause deformed or distorted staples as a result of uncut washers in the stapler, which can cause failure or serious harm to the patient. An investigation found a shift in the manufacturing process from March 2018 to March 2019, the manufacturing dates of the potentially defective surgical staplers. So far, two serious injuries have been reported as a result of the defective product, which caused a resection in the middle rectum of one patient and in the lower rectum of another patient, during planned resections of the upper rectum.

Contact Your Doctor Immediately If You Experience These Symptoms

If you are a patient that has undergone gastrointestinal surgery, you may have been affected by the defective surgical stapler manufactured by Johnson & Johnson’s Ethicon. The potential misfiring and failure of the staplers manufactured between March 2018 and March 2019 may result in digestive issues, bleeding, sepsis, anastomotic leaks, additional surgery, the requirement of an ostomy bag or even death. It is imperative you seek the help of a health care professional if you are at risk of developing any of these side effects.

Consult a Dedicated Product Liability Attorney at Sullivan, Papain, Block, McGrath & Cannavo P.C.

Health care manufacturers have the vital responsibility to ensure each and every one of their products is safe for use by surgeons and their patients. The pharmaceutical liability attorneys at Sullivan, Papain, Block, McGrath & Cannavo have years of experience representing victims of pharmaceutical product failure so they can receive compensation for medical expenses and pain and suffering. If you underwent gastrointestinal surgery that used recalled Johnson & Johnson unit Ethicon’s Endo-Surgery Curved Intraluminal Stapler with Adjustable Height Staples, contact the product liability attorneys at Sullivan, Papain, Block, McGrath & Cannavo P.C. today.