Surgical Suture Recall Due to Silicone Curing Defect
Ethicon Endo Surgery recalls ETHIBOND EXCEL surgical sutures worldwide due to curing issues with the silicone coating on the needles identified during manufacturing.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall with no reported illnesses or injuries. This is a risk-of-harm medical device—a manufacturing defect in surgical sutures could compromise suture integrity during surgical use—but no adverse events have been reported, qualifying it as High severity per the rubric.
Plain-English summary
Ethicon Endo Surgery, LLC is recalling ETHIBOND EXCEL surgical sutures (Product Code X843H-56, Lot 10489X) due to identified curing issues with the silicone applied during needle manufacturing.
The defect affects approximately 2,556 units distributed worldwide, including the United States and numerous international markets. The curing issue means the silicone coating on the needles may not have properly solidified during the manufacturing process.
Healthcare facilities and surgical centers using affected sutures should discontinue use and contact Ethicon Endo Surgery for instructions on returning product or obtaining replacements. Any adverse events or complications associated with these sutures should be reported to the FDA.
The recalled product
- Product
- ETHIBOND EXCEL GRN 36IN(90CM) USP2-0(M3) D/A MH
- Manufacturer
- Ethicon Endo Surgery, LLC
- Category
- Medical Device — Surgical Suture
- Hazard
- manufacturing-defect
- material-defect
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Product Code: X843H-56
- GMDN: 13906
- UDI-DI: 10705031058088
- Lot number: 10489X
Distribution
Distributed nationwide across the United States.
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