Ethicon, Llc: Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile
Recall Summary Ethicon is recalling PERMA-HAND Silk Black Braided surgical sutures (Product Code N271H) because some packages contain an unintended alcohol-based fluid that was not part of the product design. If the fluid is present when the suture is used in surgery, it could weaken the suture's strength, compromise knot security, or cause tissue irritation, potentially leading to wound complications like bleeding or failure to heal. The affected sutures were distributed nationwide across the United States and Canada.
- Recalling firm
- Ethicon, LLC
- Product
- PERMA-HAND Silk Black Braided Sterile Nonabsorbable Surgical Suture, 1X18" TF-5, Product Code: N271H
- Reason
- Silk sutures, indicated for use in cardiovascular, ophthalmic and neurological procedures, packaged with alcohol-based fluid, not part of product design, that if discovered prior to use may cause surgical delay. If used, fluid could cause reduced suture tensile strength or knot security, tissue irritation/inflammatory tissue response, and treatment failure, including wound dehiscence/bleeding.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-09-08
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- Worldwide - US Nationwide distribution in the states of SC, PA, TX, CA, ID, LA, MO, AL, NC, UT, IL, MA, OH, AZ, TN, OK, NE, ME, IN, WI, FL, CO, WY, NH, NY, NC, MN and the country of CA.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/f915bab5-93dd-499d-ab66-fa2e257524aa