Class II — Potential Health Hazard

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

PROLENE SUTURE 30"(75CM) 4-0 BLUE Recalled by Ethicon, Inc. Due to The needle associated with certain suture product codes...

Date: May 7, 2018
Company: Ethicon, Inc.
Status: Terminated
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

PROLENE SUTURE 30"(75CM) 4-0 BLUE, D7748

Quantity: 2844

Why Was This Recalled?

The needle associated with certain suture product codes has the potential to perforate the packaging due to a packaging design issue. A perforated package has the potential to cause a soft tissue injury to a healthcare professional handling the subject product or a patient infection due to a breach of sterility within the packaging if it goes unnoticed by the healthcare professional.

Where Was This Sold?

This product was distributed to 25 states: AZ, CA, CO, FL, GA, IL, IN, KS, MA, MN, MO, NE, NJ, NY, NC, OH, OR, SC, SD, TN, TX, VA, WA, WV, WI

Affected (25 states)Not affected

About Ethicon, Inc.

Ethicon, Inc. has 69 total recalls tracked by RecallDetector.

Related Recalls

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