FDA Flags Safety Concerns Over Ethicon Surgical Staplers After Reports of Lockout Events

The FDA has issued a safety notice regarding Johnson & Johnson’s Ethicon surgical staplers, highlighting a malfunction that may result in device lockout during procedures. This issue, linked to one death and one injury, may prevent the stapler from cutting or sealing tissue, potentially leading to bleeding, surgical delays, or life-threatening complications.

Ethicon, which sells reloadable stapler cartridges, observed a rise in lockout incidents and contacted customers in April. The issue was formally added to the FDA’s Class I recall list in May, impacting over 678,000 products.

Though the stapler includes safeguards against vessel injury during clamping, the failure to advance the knife or properly staple tissue creates risks if healthcare providers are unfamiliar with the removal protocol.

Ethicon has issued an Urgent Medical Device Correction and provided training materials, including a video, to guide clinicians in safely addressing the malfunction.

31-07-2025