FDA recall, , Moderate risk
Ethicon Ethilon Nylon Suture
Ethilon Nylon Suture may have needles with distorted curvature that may break during use, causing additional soft tissue or vessel injury.
Summary by Recall Canary from the FDA notice
What happened
Ethicon, LLC began a recall of ETHILON Nylon Suture, Product Code 697G, on September 23, 2026, according to the FDA. The nylon suture, indicated for use in general soft tissue approximation and/or ligation, may have needles with distorted curvature that may break during use, potentially causing additional soft tissue or vessel injury, including tearing or bleeding intraoperatively.
The recall was added to the FDA's Enforcement Report and classified on October 23, 2026, with distribution to California and international distribution to the countries of JP, CA, AU.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Match the UDI-DI and lot code listed under your product.
A UDI-DI is the device identifier printed with the barcode on the device label.
ETHILON Nylon Suture, Product Code 697G
- UDI-DI
- 30705031008568
- 10705031008564
- Lot code
- 10B3QS
Recall details
- Company began the recall
- Sold in
International distribution to the countries of JP, California, AU.
- Company
- Ethicon, LLC
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99947
- Recall number
- Z-0284-2027
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
