ETHILON Nylon Suture recall (Ethicon, LLC)
Medical deviceClass IIOngoing
Summary: Ethicon, LLC is recalling 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.
What is being recalled
ETHILON Nylon Suture, Product Code 697G
Why
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.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
International distribution to the countries of JP, CA, AU. (states named: California)
How to tell if yours is affected
GTIN Box/Unit: 30705031008568/10705031008564. Lot: 10B3QS
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-0284-2027 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | September 23, 2026 |
| Reported | November 4, 2026 |
| Company | Ethicon, LLC |
| Company location | San Lorenzo, PR, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 4,003 |
More recalls from Ethicon, LLC · all medical device recalls · recalls from September 2026