ETHICON, INC. recalls MONOCRYL" (poliglecaprone 25) Suture REF Y936H MONOCRYL" Sutures are indicated for use in general soft tissue approxima…

Recall date

October 8, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0487-2025

FDA classification

Class II

Brand / firm

ETHICON, INC.

Sold / distributed

U.S.: AK, AL, AR, AZ, CA, CO,CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY. O.U.S.: Not provided.

Why it was recalled

Due a component mix-up in manufacturing, the affected products may contain incorrect needle type/size and suture length.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

MONOCRYL" (poliglecaprone 25) Suture REF Y936H MONOCRYL" Sutures are indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular and neurological tissues, microsurgery or ophthalmic surgery.