Ethicon Endo-Surgery Inc: Medical Device Recall in 2019 - (Recall #: Z-0203-2020)

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:

ECHELON FLEX Powered Plus ENDOPATH 60mm Stapler - 340mm shaft, Product Code PSEE60A

Product Classification:

Class I

Date Initiated: October 3, 2019

Date Posted: November 6, 2019

Recall Number: Z-0203-2020

Event ID: 83897

Reason for Recall:

The staplers may contain an out of specification anvil component within the jaw of the device. This condition may lead to malformed staples, which can compromise staple line integrity. If the staple line is compromised, there is a potential risk of prolonged surgery, postoperative anastomotic leak, hemorrhage, hemorrhagic shock, additional surgical intervention, or death.

Status: Terminated

Product Quantity: 2112 units

Code Information:

Lot: T93Z5W, T93Z5X, T9405V, T9405W, T93Z3F, T9401L, T93Y8X, T94008, T9400D, T93Z5R

Distribution Pattern:

Worldwide distribution. US Nationwide. Belgium, Brazil, Canada, Chile, Colombia, Japan, Kuwait, Saudi Arabia, and Singapore.

Voluntary or Mandated:

Voluntary: Firm initiated