Ethicon Endo-Surgery Inc: Medical Device Recall in 2021 - (Recall #: Z-2326-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

ECHELON FLEX Powered Plus Stapler-intended for transection, resection, and/or creation of anastomoses. The instruments have application in multiple open or minimally invasive general, gynecologic, urologic, thoracic, and pediatric surgical procedures. Product Code: PSEE60A

Product Classification:

Class II

Date Initiated: June 3, 2021

Date Posted: August 25, 2021

Recall Number: Z-2326-2021

Event ID: 88349

Reason for Recall:

Mislabeled: Labeled on the package as 60mm contains 45mm devices

Status: Terminated

Product Quantity: 763 eaches

Code Information:

Lot U94V47 Exp Date: July 31, 2023 GTIN: 10705036014607

Distribution Pattern:

Worldwide distribution - US Nationwide distribution in the states of MD, WA and the countries of Belgium, China, Denmark, Estonia, France, Germany, Italy, Japan, Korea, Latvia, Lithuania, Netherlands, Poland, Portugal, Russia, Spain, Sweden, Switzerland, United Kingdom.

Voluntary or Mandated:

Voluntary: Firm initiated