FDAFDA recall Z-0153-2027 · Oct 21, 2026
Ethicon, LLC: PERMA-HAND Silk Black Braided Sterile Nonabsorbable Surgical Suture recall
Recall found
Product
PERMA-HAND Silk Black Braided Sterile Nonabsorbable Surgical Suture, 1X18" TF-5, Product Code: N271H
Reason for recall
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.
What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
- Status
- Ongoing
- Codes, lots and dates
- UDI-DI:Box/Unit: 30705031047369/10705031047365. Lot: RLBDPJ. Expiration: SEPTEMBER 30, 2026
- Quantity
- 1764
- 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.
- Recalling firm
- Ethicon, LLC, San Lorenzo, PR
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-09-08
Source: openFDA enforcement record Z-0153-2027 · search recall number Z-0153-2027 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 26, 2026, 8:14 PM EDT. The agency notice is the final word.