Ethicon Surgical Stapler Injury & Wrongful Death Lawsuit Lawyers

Ethicon Stapler Cartridges Recalled Over Critical Device Lockout Risk

A nationwide recall of surgical stapler cartridges manufactured by Johnson & Johnson’s Ethicon unit has raised significant alarm following the report of one death and one injury. According to the U.S. Food and Drug Administration (FDA), the recall has been classified as a Class I, the most serious type, due to the potential for life-threatening surgical complications. The issue stems from a defect that can cause the device to lock and fail to perform its essential function of cutting and stapling tissue during surgical procedures.

Surgical staplers are used in a wide range of surgeries to seal internal tissue and blood vessels. When these devices fail, surgeons are forced to take emergency measures to protect the patient. In the Ethicon recall, the cartridges can misfire, resulting in failed activation and lockout. The device may not cut or staple as intended, and may become stuck in the patient’s tissue. Such a malfunction can result in severe bleeding, life-threatening hemorrhagic shock, surgical delays, and the need to convert from a minimally invasive procedure to open surgery.

Ethicon has advised healthcare providers to stop using the affected products immediately and follow the protocols laid out in the company’s urgent medical device correction letter. Over 678,000 affected units were in circulation when the issue was identified.

Devices Impacted and Surgical Settings Affected

Ethicon’s surgical stapler cartridges are used in operating rooms across hospitals nationwide and are an essential tool in general, gynecological, and gastrointestinal surgeries. These cartridges are part of reloadable stapling systems that cut and seal tissue simultaneously. The cartridges contain staggered rows of staples and are designed to fit into reusable device jaws.

The defect does not lie in the stapler handle but in the cartridge. If a lockout occurs, the stapler’s knife blade may not travel far enough to complete the cut. Meanwhile, the staples remain unformed and below the tissue surface, putting critical blood vessels and organs at risk. Removing a jammed stapler requires extra steps and can cause surgical delays that threaten patient safety.

The recalled devices include specific lots that were distributed widely to hospitals, surgical centers, and outpatient facilities. Ethicon has provided a video tutorial for surgeons on what to do if the device locks during use, though that is small comfort for patients harmed before the defect became widely known.

FDA Class I Recall Classification and Its Meaning

The FDA’s decision to classify this recall as Class I signals an extremely high risk of patient harm. Class I recalls are reserved for situations where a product defect is likely to cause serious injury or death. Ethicon’s staplers were designed with safety features meant to prevent exactly this type of lockout scenario. However, those features failed to protect at least one patient, and possibly more whose cases have yet to be confirmed.

Lockout-related injuries are not limited to bleeding. Other possible complications include internal organ damage, infection, the need for revision surgery, extended recovery times, and post-operative trauma. The presence of a locked surgical device during a procedure creates a crisis situation for the surgical team, especially when working in delicate areas of the body.

While Ethicon has issued correction letters and updated its training protocols, the damage caused by the defect has already been done in some cases. Patients who underwent surgeries involving these staplers should review their operative reports and consult their physicians about which devices were used.

Legal Rights for Patients Harmed by Recalled Ethicon Staplers

Patients who experienced surgical complications involving the recalled staplers may have legal options. Device manufacturers have a legal responsibility to design and produce medical tools that are safe, effective, and rigorously tested. When a device fails during a critical procedure and causes harm, that responsibility has been breached.

Legal claims may arise under product liability law, particularly for manufacturing defects and failure to warn. Victims may be entitled to pursue financial compensation for:

• Medical costs, including additional surgeries or hospitalization
• Lost wages due to extended recovery or permanent disability
• Pain and suffering
• Emotional and psychological trauma
• Long-term medical care

In some cases, claims may also extend to negligent marketing if the manufacturer continued distribution after knowing of the defect. The existence of one confirmed death and multiple adverse reports supports the seriousness of potential litigation.

Steps Patients Should Take If Affected

Patients who underwent surgery between early 2023 and 2025 should consult with their surgical team and obtain a copy of their operative records. These records may identify whether Ethicon staplers or cartridges were used. Patients who experienced unexpected post-surgical complications, such as heavy internal bleeding, extended surgery times, or emergency conversion to open surgery, may have been impacted by the defect.

It is important not to wait. Medical device litigation is subject to strict time limits under state and federal law. A legal evaluation can determine whether a claim is viable and what kind of compensation might be available. Legal representation is especially critical in medical device cases, which often involve complex technical evidence and well-resourced corporate defendants.

Contact Parker Waichman LLP For A Free Case Review

If you or a loved one suffered complications after surgery involving Ethicon surgical staplers, you may have a right to compensation. Parker Waichman LLP is investigating claims nationwide and has a long history of representing victims harmed by defective medical devices. Call 1-800-YOUR-LAWYER (1-800-968-7529) today for a free and confidential consultation. Let us help protect your rights and fight for the justice you deserve.

Regardless of your location or where your injury occurred, our nationwide product injury law firm is ready to assist you and provide you with a free consultation.