Lower risk Medical device recall · FDA · Published September 9, 2020

Ethicon VICRYL Suture Recall: Incorrect Size May Cause Surgical Errors

Ethicon recalls VICRYL monofilament sutures that may have wrong size (6-0 vs 10-0) for eye surgery. Incorrect sutures could lead to improper wound closure. Affected products sold between 2020-2024.

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

🇺🇸 FDA recall #Z-0116-2021Medical device Ethicon ›

Lower-risk recall

Product in the foil package for VICRYL V960 may not match the foil label and sales unit carton. The correct VICRYL suture is size 10-0, 4 inches (10 cm) in length, has monofilament construction, and a single needle. The incorrect VICRYL suture is size 6-0, 18 inches (45 cm) in length, has braided construction, and two needles

Take action

Contact the company

Recalling firmEthicon, Inc.Us Highway 22 West · Somerville, NJ 08876

✎ GovInfoNow plain-language explainer

Ethicon is recalling VICRYL monofilament sutures that might be the wrong size for eye surgery. Using the incorrect suture could cause improper wound closure during procedures. This affects surgeons and medical staff who use these sutures. Read more at govinfonow.com/recall/64329-ethicon-vicryl-suture-recall-incorrect-size-may-cause-surgical-errors.

Source Summary by GovInfoNow · govinfonow.com/recall/64329-ethicon-vicryl-suture-recall-incorrect-size-may-cause-surgical-errors · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0116-2021

Cite this page

“Ethicon VICRYL Suture Recall: Incorrect Size May Cause Surgical Errors.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/64329-ethicon-vicryl-suture-recall-incorrect-size-may-cause-surgical-errors. Based on FDA recall #Z-0116-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0116-2021%22&limit=1).

Ethicon, Inc. recalled VICRYL MONOFILAMENT VIOLET sutures on Sept. 9, 2020, after the product in the foil package did not match the label, according to the FDA. The agency announced the Class II recall of 1,032 units distributed internationally.

How to tell if you have it

Brand: Ethicon
Product: VICRYL MONOFILAMENT VIOLET 4IN (10CM) USP 10-0 (M0.2) SINGLE-ARMED CS140-6
Product Code: V960G
Lot No.: PJ5352
Expiry Date: 07/31/2024
UDI (GTIN): 10705031051324

The hazard

The hazard involves a mismatch where the foil package contains an incorrect VICRYL suture instead of the intended monofilament size 10-0, single-needle product. The incorrect item is size 6-0, 18 inches long, with braided construction and two needles.

Context

GovInfoNow's records show ETHICON, INC. has 25 other recalls on record since 2017-08-17. Other recent recalls of similar products include Ethicon Monocryl Sutures Recall (2024-10-08), Ethicon Coated VICRYL Suture Recall (2024-09-25), and Ethicon VICRYL Plus Suture Recall (2024-05-10). Other recent recalls of similar products include Covidien Dermalon 4-0 Blue 75cm Sutures Recall (2026-06-24), Boston Scientific OverStitch Suture Cinch Recall (2026-07-14), and Covidien V-Loc 180 Absorbable Wound Closure Device Recall (2026-06-24).

How to tell if you have this one

Check for the product code V960G on the foil package. Products with lot/serial number PJ5352 and expiry date 07/31/2024 are affected. These were sold between 2020 and 2024.

Brand
Ethicon
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Details
Verify the product code on the foil package is V960G and the lot/serial number is PJ5352 with expiry date 07/31/2024.

How this recall unfolded

Recall timeline

FDA terminated this recall 3.2 years after the firm started it.

Sep 9, 2020Firm started the recall
Oct 16, 2020FDA classified it Class II
Oct 28, 2020Published in FDA’s Enforcement Report
Nov 7, 2023FDA terminated the recall

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/64329-ethicon-vicryl-suture-recall-incorrect-size-may-cause-surgical-errors">Ethicon VICRYL Suture Recall: Incorrect Size May Cause Surgical Errors (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-0116-2021 (September 9, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0116-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 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.