Class 2 Device Recall ETHILON" Nylon Suture

• Date Initiated by Firm: September 23, 2026
• Date Posted: October 23, 2026
• Recall Status: Open, Classified
• Recall Number: Z-0284-2027
• Recall Event ID: 99947
• 510(K)Number: K946173
• Product Classification: Suture, nonabsorbable, steel, monofilament and multifilament, sterile - Product Code GAQ
• Product: ETHILON Nylon Suture, Product Code 697G
• Code Information: GTIN Box/Unit: 30705031008568/10705031008564. Lot: 10B3QS
• FEI Number: 2648650
• Recalling Firm/ Manufacturer: Ethicon, LLC; Highway 183 Km 8.3; San Lorenzo PR 00754
• For Additional Information Contact: 787-783-7070
• Manufacturer Reason for Recall: Nylon suture indicated for use in general soft tissue approximation and/or ligation may have needles with distorted curvature, that may break during use, or could cause additional soft tissue or vessel injury, including tearing or bleeding intraoperatively.
• FDA Determined Cause: Process control
• Action: On 9/3/2026, field safety notices were mailed to customers who were asked to do the following: 1) Examine your inventory immediately to determine if you have product subject to this recall on hand and quarantine such product(s). If you have product subject to this recall, please maintain a copy of this notice with the quarantined product and keep a copy for your records. 2. Return affected product to firm. 3. Communicate the issue to relevant operating room or materials management personnel, or anyone else in your facility who needs to be informed. If any product subject to this recall has been forwarded to another facility, contact that facility to arrange return and forward them this recall notice. 4. Complete and return the Business Reply Form (BRF) via email to RA-ITSUS-JJMCanada@ITS.JNJ.com
• Quantity in Commerce: 4,003
• Distribution: International distribution to the countries of JP, CA, AU.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = GAQ