Ethicon Endo-Surgery Inc: Medical Device Recall in 2019 - (Recall #: Z-1276-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

Straight Intraluminal Staplers, 25 mm diameter, Model SDH25A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers available in four sizes to permit proper matching of instrument to diameter of the lumen. The instrument permits tissue attachment to the anvil shaft in a location remote from the main body of the instrument to improve access and visibility.

Product Classification:

Class I

Date Initiated: April 11, 2019

Date Posted: May 22, 2019

Recall Number: Z-1276-2019

Event ID: 82539

Reason for Recall:

The staplers may have an insufficient firing stroke to break the washer and completely form staples.

Status: Completed

Product Quantity: 434,614 total

Code Information:

All Lots within EXPIRATION Date Range: February 2023 March 2024

Distribution Pattern:

Worldwide Distribution: US (nationwide) and countries of: Argentina, Aruba, Bahrain, Bangladesh, Belgium, Bolivia, Brazil, Canada, Chile, China, Columbia, Costa Rica, Ecuador, Egypt, El Salvador, Guatemala, Honduras, India, Indonesia, Israel, Jamaica, Japan, Jordan, Korea, Kuwait, Lebanon, Malaysia, Maldives, Mexico, Nepal. Nicaragua, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Qatar, Saudi Arabia, Singapore, Sri Lanka, Taiwan, Thailand, UAE, Uruguay, Vietnam, and Yemen.

Voluntary or Mandated:

Voluntary: Firm initiated