Ethicon, LLC recalls PERMA-HAND Silk Black Braided Sterile Nonabsorbable Surgical Suture

Recalling company

Ethicon, LLC

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.

Classification

Class II – may cause temporary or medically reversible health consequences

Recall date

Sep 8, 2026

Reported

Oct 21, 2026

Distribution

Worldwide - US Nationwide distribution in the states of SC, PA, TX, CA, ID, LA, MO, AL, NC, UT, IL, MA, OH, AZ, TN, OK, NE, ME, IN, WI, FL, CO, WY, NH, NY, NC, MN and the country of CA.

Status

Ongoing

Quantity

1764

Lot / codes

UDI-DI:Box/Unit: 30705031047369/10705031047365. Lot: RLBDPJ. Expiration: SEPTEMBER 30, 2026

Company location

San Lorenzo, PR

Recall type

Voluntary: Firm initiated

Recall number

Z-0153-2027

Agency

U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-0153-2027 in the FDA Enforcement Report. Also see FDA recall press releases.