Ethicon Stapler Recall

Ethicon Stapler Recall May 2019

The FDA recently recalled over 90,000 surgical staplers from Johnson and Johnson’s subsidiary Ethicon on May 15th, 2019 labeling it a Class-I Recall. The FDA investigation was initiated in the beginning of March 2019, announcing a plan to review and address the safety of Surgical Staplers.

As the Ethicon Staplers went under a safety review, an Alternative Summary Reporting system was surfaced that many doctors and medical professionals were unaware of. This system has brought over 6 million reports in the last 20 years to the public eye. Of many devices reported to this system the surgical stapler is one, with over 100,000 reports since 2011.

Ethicon Staplers Recalled on May 15th, 2019:
• Endoscopic Curved Intraluminal Stapler, 29 mm diameter, Model ECS29A
• Curved Intraluminal Staplers, 21 mm diameter, Model CDH21A
• Curved Intraluminal Staplers, 25 mm diameter, Model CDH25A
• Curved Intraluminal Staplers, 33 mm diameter, Model CDH33A
• Straight Intraluminal Staplers, 33 mm diameter, Model SDH33A
• Straight Intraluminal Staplers, 29 mm diameter, Model SDH29A
• Straight Intraluminal Staplers, 25 mm diameter, Model SDH25A
• Straight Intraluminal Staplers, 21 mm diameter, Model SDH21A
• Endoscopic Curved Intraluminal Stapler, 33 mm diameter, Model ECS33A
• Endoscopic Curved Intraluminal Stapler, 25 mm diameter, Model ECS25A
• Endoscopic Curved Intraluminal Stapler, 21 mm diameter, Model ECS21A

*Please note, these are the staplers recalled on May 15th,2019. Other staplers have been recalled and are under equivalent review.