Recall Z-1516-2025— Ethicon Endo Surgery, LLC

Name: FDA recall Z-1516-2025
Creator: U.S. Food and Drug Administration
Published: 2025-03-07

Class II · Ongoing

Class II FDA medical device recall by Ethicon Endo Surgery, LLC, initiated 2025-03-07. It names one FDA 510(k) clearance: K946173. Product: ETHIBOND EXCEL GRN 36IN(90CM) USP2-0(M3) D/A MH. Reason: Identified curing issues with the silicone during the needles manufacturing process..

Recalling firm: Ethicon Endo Surgery, LLC
Classification: Class II
Status: Ongoing
Initiated: 2025-03-07
Firm location: Guaynabo, PR, United States

510(k) clearances named in this recall

1 on FDA's record

K946173 — STAINLESS STEEL, GUT, POLY (GLYCOLIDE/L-LACTIDE) POLYAMIDE, POLYPROPYLENE, POLY (ETHYLENE TEREPHTHALATE) AND SILKETHICON, Inc.·cleared 1995-01-09

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

ETHIBOND EXCEL GRN 36IN(90CM) USP2-0(M3) D/A MH

Reason for recall

Identified curing issues with the silicone during the needles manufacturing process.

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