Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

MONOCRYL" (poliglecaprone 25) Suture REF Y936H MONOCRYL" Sutures are indicated Recalled by ETHICON, INC. Due to Due a component mix-up in manufacturing, the affected...

Date: October 8, 2024
Company: ETHICON, INC.
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact ETHICON, INC. directly.

Affected Products

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.

Quantity: 16,524 devices

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed to 45 states: AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, ID, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WV, WI, WY

Affected (45 states)Not affected

About ETHICON, INC.

ETHICON, INC. has 1 total recall tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report