Recall Z-0147-2026— Ethicon Endo-Surgery Inc

Name: FDA recall Z-0147-2026
Creator: U.S. Food and Drug Administration
Published: 2025-09-11

Class II · Ongoing

Class II FDA medical device recall by Ethicon Endo-Surgery Inc, initiated 2025-09-11. It names one FDA 510(k) clearance: K223760. Product: ECHELON LINEAR Cutters Reload 80 mm Blue, intended for transection, resection, and/or creation of anastomoses, Product Number GLC80. Reason: The devices were shipped unsterilized..

Recalling firm: Ethicon Endo-Surgery Inc
Classification: Class II
Status: Ongoing
Initiated: 2025-09-11
Firm location: Blue Ash, OH, United States

510(k) clearances named in this recall

1 on FDA's record

K223760 — ECHELON LINEAR 60 mm Cutter (GLC60) +8 moreEthicon Endo-Surgery·cleared 2023-03-15

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 LINEAR Cutters Reload 80 mm Blue, intended for transection, resection, and/or creation of anastomoses, Product Number GLC80

Reason for recall

The devices were shipped unsterilized.

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