Johnson & Johnson’s Ethicon division has issued a correction and Class 1 recall of its Echelon surgical stapler reload cartridges, following reports of a serious defect linked to at least one death and multiple injuries. The U.S. Food and Drug Administration (FDA) has confirmed that 678,526 units are affected by the recall, which involves staplers used to cut and staple tissue during surgery.
The FDA warned that the stapler may lock during use, failing to properly cut or seal tissue. This malfunction can result in the device becoming trapped in the patient, causing surgical delays, excessive bleeding, hemorrhagic shock, emergency conversion to open surgery, and even death.
Legal Responsibilities of Manufacturers, Hospitals, and Surgeons
While Ethicon is facing scrutiny for the product’s design and post-market safety response, liability does not end with the manufacturer. Hospitals, surgical centers, and the physicians who choose to continue using a known defective device may also be held legally accountable.
Healthcare providers have a legal duty of care to stay informed about product recalls and adverse safety alerts. If a surgeon uses a recalled stapler after receiving a warning—especially in light of an FDA Class 1 designation—and a patient is injured as a result, that may constitute medical malpractice. The same applies to hospitals that fail to remove recalled devices from surgical inventory or fail to train staff on handling known malfunctions.
Ethicon’s recall notice includes instructions on how to manage a lockout if it occurs, but relying on workaround videos and post-hoc fixes is not a substitute for safe and effective medical care. When patient safety is compromised by either a dangerous product or a failure to act on known risks, legal accountability may extend to both the device manufacturer and the medical providers involved.
What You Can Do
If you or a loved one suffered complications during or after a surgery involving an Ethicon stapler, you may have a legal claim. Depending on the facts, this could involve product liability, medical malpractice, or both.
At Gair, Gair, Conason, Rubinowitz, Bloom, Hershenhorn, Steigman & Mackauf, we have decades of experience litigating high-stakes cases involving defective medical devices and negligent healthcare providers. We work with top medical experts to investigate surgical injuries and uncover whether a faulty product or substandard care was to blame.
Contact Us
For a free consultation with one of our experienced attorneys, call 212-943-1090 or visit our product liability or medical malpractice pages to learn more.