Recall Z-0153-2027— Ethicon, LLC

Name: FDA recall Z-0153-2027
Creator: U.S. Food and Drug Administration
Published: 2026-09-08

Class II · Ongoing

Class II FDA medical device recall by Ethicon, LLC, initiated 2026-09-08. It names one FDA 510(k) clearance: K946173. Product: PERMA-HAND Silk Black Braided Sterile Nonabsorbable Surgical Suture, 1X18" TF-5, Product Code: N271H. Reason: Silk sutures, indicated for use in cardiovascular, ophthalmic and neurological procedures, packaged with alcohol-based fluid, not part of product design, that if discovered prior to use may cause surgical delay. If used, fluid could cause reduced suture tensile strength or knot security, tissue irritation/inflammatory tissue response, and treatment failure, including wound dehiscence/bleeding..

Recalling firm: Ethicon, LLC
Classification: Class II
Status: Ongoing
Initiated: 2026-09-08
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

PERMA-HAND Silk Black Braided Sterile Nonabsorbable Surgical Suture, 1X18" TF-5, Product Code: N271H

Reason for recall

Silk sutures, indicated for use in cardiovascular, ophthalmic and neurological procedures, packaged with alcohol-based fluid, not part of product design, that if discovered prior to use may cause surgical delay. If used, fluid could cause reduced suture tensile strength or knot security, tissue irritation/inflammatory tissue response, and treatment failure, including wound dehiscence/bleeding.

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