{"recall":{"id":"fda-device-99754","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"Ethicon, LLC recalls PERMA-HAND Silk Black Braided Sterile Nonabsorbable Surgical Suture","firm":"Ethicon, LLC","date":"2026-09-08","reported":"2026-10-21","status":"Ongoing","classification":"Class II","products":[{"name":"PERMA-HAND Silk Black Braided Sterile Nonabsorbable Surgical Suture, 1X18\" TF-5, Product Code: N271H","code":"UDI-DI:Box/Unit: 30705031047369/10705031047365. Lot: RLBDPJ. Expiration: SEPTEMBER 30, 2026","quantity":"1764","number":"Z-0153-2027","classification":"Class II"}],"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.","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"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.","nationwide":true,"states":[],"units":"1764","remedy":"","whatToDo":"Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.","contact":"","url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99754","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"7fa76975c486300b","firstSeen":"2026-11-02T13:57:14.206Z","updatedAt":"2026-11-02T13:57:14.206Z","history":[]},"official":{"fetchedAt":"2026-11-02T13:57:14.206Z","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","officialUrl":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99754","record":[{"status":"Ongoing","city":"San Lorenzo","state":"PR","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99754","recalling_firm":"Ethicon, LLC","address_1":"Highway 183 Km 8.3","address_2":"","postal_code":"00754","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"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.","recall_number":"Z-0153-2027","product_description":"PERMA-HAND Silk Black Braided Sterile Nonabsorbable Surgical Suture, 1X18\" TF-5, Product Code: N271H","product_quantity":"1764","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.","recall_initiation_date":"20260908","center_classification_date":"20261014","report_date":"20261021","code_info":"UDI-DI:Box/Unit: 30705031047369/10705031047365. Lot: RLBDPJ. Expiration: SEPTEMBER 30, 2026","more_code_info":""}]}}