Ethicon, Llc: Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile
Recall Summary Ethicon is recalling ETHILON Nylon Suture (Product Code 697G) used for closing wounds and tying off blood vessels because the needles may be bent or curved incorrectly, which could cause them to break during surgery or damage nearby tissue and blood vessels. The affected product was distributed to Japan, Canada, and Australia, with some distribution in California. This is a Class II recall, indicating a potential serious health risk.
- Recalling firm
- Ethicon, LLC
- Product
- ETHILON Nylon Suture, Product Code 697G
- Reason
- 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.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-09-23
- Status
- Open, Classified
- Areas affected
- CA
- Distribution
- International distribution to the countries of JP, CA, AU.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/81b0b523-4baf-4b35-a627-10d32fcdca67