FDA recall, , Moderate risk
Ethicon PERMA-HAND Silk Surgical Suture
PERMA-HAND Silk surgical sutures may contain alcohol-based fluid, causing surgical delay or tissue irritation.
Summary by Recall Canary from the FDA notice
What happened
Ethicon, LLC is recalling PERMA-HAND Silk Black Braided Sterile Nonabsorbable Surgical Suture, 1X18" TF-5, Product Code: N271H, because the sutures, indicated for use in cardiovascular, ophthalmic and neurological procedures, may be packaged with alcohol-based fluid not part of the product design. If the fluid is discovered prior to use, it may cause surgical delay.
If used, the fluid could cause reduced suture tensile strength or knot security, tissue irritation/inflammatory tissue response, and treatment failure, including wound dehiscence/bleeding.
The recall began on September 8, 2026, and was added to the FDA's Enforcement Report on October 14, 2026. The product was distributed worldwide, including US nationwide distribution in states such as SC, PA, TX, CA, and others, and the country of CA.
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 product code listed under your product.
A UDI-DI is the device identifier printed with the barcode on the device label.
PERMA-HAND Silk Black Braided Sterile Nonabsorbable Surgical Suture, 1X18" TF-5
- UDI-DI
- 30705031047369
- 10705031047365
- Product code
- N271H
Recall details
- Company began the recall
- Sold in
Worldwide - US Nationwide distribution in the states of South Carolina, Pennsylvania, Texas, California, Idaho, Louisiana, Missouri, Alabama, North Carolina, Utah, Illinois, Massachusetts, Ohio, Arizona, Tennessee, Oklahoma, Nebraska, Maine, Indiana, Wisconsin, Florida, Colorado, Wyoming, New Hampshire, New York, North Carolina, Minnesota and the country of California.
- 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
- 99754
- Recall number
- Z-0153-2027
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
In FDA's weekly enforcement report
