Recall Z-0284-2027— Ethicon, LLC

Name: FDA recall Z-0284-2027
Creator: U.S. Food and Drug Administration
Published: 2026-09-23

Class II · Ongoing

Class II FDA medical device recall by Ethicon, LLC, initiated 2026-09-23. It names one FDA 510(k) clearance: K946173. Product: ETHILON Nylon Suture, Product Code 697G. Reason: Nylon suture indicated for use in general soft tissue approximation and/or ligation may have needles with distorted curvature, that may break during use, or could cause additional soft tissue or vessel injury, including tearing or bleeding intraoperatively..

Recalling firm: Ethicon, LLC
Classification: Class II
Status: Ongoing
Initiated: 2026-09-23
Firm location: San Lorenzo, 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

ETHILON Nylon Suture, Product Code 697G

Reason for recall

Nylon suture indicated for use in general soft tissue approximation and/or ligation may have needles with distorted curvature, that may break during use, or could cause additional soft tissue or vessel injury, including tearing or bleeding intraoperatively.

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