Lower risk Medical device recall · FDA · Published October 8, 2024

Ethicon Monocryl" Sutures Recall: Incorrect Needle/Size Risk

Ethicon recalls Monocryl" sutures with incorrect needle type or size due to manufacturing mix-up. Affected products may have wrong suture length. Consumers should check product details and contact Ethicon for remedy.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0487-2025Medical device Ethicon ›

Lower-risk recall

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

Take action

Contact the company

Recalling firmETHICON, INC.Calle Durango 2751, Col. Parque Industrial Americas, Juarez · Juarez, Mexico

✎ GovInfoNow plain-language explainer

Ethicon is recalling Monocry: suture type Y936H due to a manufacturing mix-up that may include incorrect needle size or length. This could lead to improper surgical use if the suture is not the right size for the procedure. Read more at govinfonow.com/recall/53783-ethicon-monocryl-sutures-recall-incorrect-needle-size-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/53783-ethicon-monocryl-sutures-recall-incorrect-needle-size-risk · Updated August 17, 2026 · FDA enforcement record: FDA #Z-0487-2025

Cite this page

“Ethicon Monocryl" Sutures Recall: Incorrect Needle/Size Risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/53783-ethicon-monocryl-sutures-recall-incorrect-needle-size-risk. Based on FDA recall #Z-0487-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0487-2025%22&limit=1).

Ethicon Inc. voluntarily recalled MONOCRYL (poliglecaprone 25) Sutures REF Y936H due to a manufacturing component mix-up that may result in incorrect needle type or suture length, the FDA said on Oct. 8, 2024.

How to tell if you have it

Brand: Ethicon
Product: MONOCRYL (poliglecaprone 25) Suture REF Y936H
Lot Number: TMMDQD
Units affected: 16,524 devices

The hazard

The recalled sutures may contain an incorrect needle type or size and suture length due to a component mix-up in manufacturing.

Context

Ethicon has issued 25 other recalls since Aug. 17, 2017, including a Sept. 25, 2024 recall of Coated VICRYL Sutures for needle pull-off risk and a May 10, 2024 recall of PDS Plus Sutures for packaging holes. Other recent recalls of similar products include W L Gore's GORE VIABIL Short Wire Biliary Endoprosthesis (May 22, 2026), Covidien's Dermalon 4-0 Blue 75cm Sutures (June 24, 2026), and ConMed's Suture Anchor (July 14, 2026).

How to tell if you have this one

Check for product code Y936H on the suture packaging. The lot number starts with TMMDQD. These sutures were sold for general soft tissue procedures but not for cardiovascular, neurological, or eye surgeries.

Brand
Ethicon
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Details
Look for product code Y936H and lot number starting with TMMDQD on the suture packaging.

Where it went and when

Where it was distributed

Distributed in 45 states.

FDA distribution: “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.” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, Florida, Georgia, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, Wisconsin, Wyoming.

Recall timeline

FDA published this recall 50 days after the firm started it.

Oct 8, 2024Firm started the recall
Nov 19, 2024FDA classified it Class II
Nov 27, 2024Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/53783-ethicon-monocryl-sutures-recall-incorrect-needle-size-risk">Ethicon Monocryl" Sutures Recall: Incorrect Needle/Size Risk (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0487-2025 (October 8, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0487-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.