Recall Z-2326-2021— Ethicon Endo-Surgery Inc

Name: FDA recall Z-2326-2021
Creator: U.S. Food and Drug Administration
Published: 2021-06-03

Class II · Terminated

Class II FDA medical device recall by Ethicon Endo-Surgery Inc, initiated 2021-06-03, terminated 2022-09-14. It names one FDA 510(k) clearance: K202665. Product: 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. Reason: Mislabeled: Labeled on the package as 60mm contains 45mm devices.

Recalling firm: Ethicon Endo-Surgery Inc
Classification: Class II
Status: Terminated
Initiated: 2021-06-03
Terminated: 2022-09-14
Firm location: Blue Ash, OH, United States

510(k) clearances named in this recall

1 on FDA's record

K202665 — Echelon Flex 45mm Powered Plus Articulating Endoscopic Linear cutters, Echelon Flex 60mm Powered Plus Articulating Endoscopic Linear cutters, Echelon Endopath Endoscopic Linear Cutter Reloads, 45mm, Echelon Endopath Endoscopic Linear Cutter Reloads, 60mmEthicon Endo-Surgery, LLC·cleared 2020-10-15

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.