FDA-Device2026-10-23Class IIPROCESSING DEFECT
Ethicon ETHILON Nylon Suture recalled for needle defects risking breakage and tissue injury
What this means
Some ETHILON Nylon Suture needles have distorted curvature and may break during surgical use. This could cause additional injury to soft tissue or blood vessels, including tearing or bleeding during surgery.
- Check your inventory for Lot 10B3QS with GTIN 30705031008568 (box) or 10705031008564 (unit).
- Do not use affected sutures for surgical procedures.
- Contact your Ethicon distributor or surgical supply vendor for instructions on returns or replacement.
The agency's original wording
Hazard
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.
Intended for
Adults
Illnesses reported
None reported
Sold states
International distribution to the countries of JP, CA, AU.
Affected count
4,003
Manufactured in
Highway 183 Km 8.3, San Lorenzo, Puerto Rico, United States
Products
ETHILON Nylon Suture, Product Code 697G
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0284-2027More Ethicon recalls
- FDA-Device2026-10-21Ethicon PERMA-HAND Silk Surgical Suture recalled for contaminating alcohol fluid
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