{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-10-19", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "222409", "product_res_number": "Z-0153-2027", "event_date_initiated": "2026-09-08", "event_date_posted": "2026-10-14", "recall_status": "Open, Classified", "res_event_number": "99754", "product_code": "GAQ", "k_numbers": [ "K946173" ], "product_description": "PERMA-HAND Silk Black Braided Sterile Nonabsorbable Surgical Suture, 1X18\" TF-5, Product Code: N271H", "code_info": "UDI-DI:Box/Unit: 30705031047369/10705031047365. Lot: RLBDPJ. Expiration: SEPTEMBER 30, 2026", "firm_fei_number": "2648650", "recalling_firm": "Ethicon, LLC", "address_1": "Highway 183 Km 8.3", "city": "San Lorenzo", "postal_code": "00754", "country": "PR", "additional_info_contact": "787-783-7070", "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.", "root_cause_description": "Process control", "action": "On 9/8/2026, recall notices were mailed to customers who were asked to do the following:\n1) Quarantine affected products. Maintain a copy of this notice with the quarantined product and keep a copy for your records.\n2) Communicate the issue to relevant operating room or materials management personnel, or anyone else in your facility who needs to be informed. If any product subject to this recall has been forwarded to another facility, contact that facility to arrange return and forward them this recall notice.\n3) Complete and return the Business Reply Form via email to ethicon4483@sedgwick.com \n4) Return affected product using the shipping label provided.\n\nIn addition distributors were told the following: Based on your reported sales data, Ethicon will send notices directly to customers about the product subject to this recall. This notice will include instructions on returning the product for credit reimbursement. Distribute this notice within your organization and to any non-customer organization that received affected product from your facility.\n\nIf you have additional questions regarding this communication or want to report any product complaints, please contact the firm's Resource Department at 1-877-384-4266.", "product_quantity": "1764", "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.", "openfda": { "k_number": [ "K081060", "K931271", "K032468", "K140127", "K063603", "K930992", "K141007", "K170767", "K991073", "K910067", "K203855", "K984151", "K022777", "K933686", "K023411", "K913155", "K913185", "K042606", "K930940", "K873645", "K041333", "K013059", "K193209", "K865038", "K931915", "K082828", "K946173", "K030351", "K955723", "K023594", "K930740", "K172146" ], "registration_number": [ "3015718210", "9616088", "2242056", "2648623", "3006425876", "3010041511", "3007205024", "3011137372", "3008868758", "3009417901", "3018094310", "3043226252", "1833824", "3006981798", "3010692967", "3015330532", "1061124", "1000274611", "2030624", "2210968", "3018052045", "1043214", "1054241", "3004060107", "3011276344", "3004192065", "1064584", "3005953126", "3032543753", "9612501", "3045857302", "3006638824", "3014592276", "1424263", "2029275", "3013298431", "3006562124", "3004365956", "3015212339", "3017196117", "2183301", "3011689956", "3004215117", "2648650", "3016904853", "3013548553", "2032098", "1054811", "3015183635", "3012421607", "1824313", "3013403214", "1221601", "3004111573", "3007791599", "1055236", "3014273254", "9611459", "3015399803", "3014579161", "3008812560", "3012502601", "1423537", "3014461810", "3017102971", "3038718579", "1221051", "3010452421", "3029901632", "9680794", "1219930", "2320762", "1018470", "1721676", "3012494290" ], "fei_number": [ "3015718210", "2242056", "2648623", "3006425876", "1000114185", "3010041511", "3003015552", "3007205024", "3008868758", "3018094310", "3009417901", "3005747797", "3000206435", "3043226252", "3003063934", "3006981798", "3010692967", "3015330532", "1000274611", "2210968", "1000306431", "3018052045", "1043214", "3004060107", "3003495548", "3011276344", "3004192065", "3005953126", "1000112877", "3032543753", "3045857302", "3006638824", "3006562124", "3014592276", "3013298431", "3003058448", "3004365956", "3015212339", "3001236905", "3017196117", "3011689956", "3004215117", "2648650", "3016904853", "2183301", "3013548553", "3002902735", "3015183635", "3012421607", "1824313", "3013403214", "3003040625", "3003737899", "1221601", "3004111573", "3007791599", "1000112968", "3014273254", "1000512168", "3015399803", "3014579161", "3008812560", "3012502601", "3014461810", "3017102971", "3038718579", "1221051", "3010452421", "3002807993", "3029901632", "1000115331", "1219930", "1018470", "1721676", "3012494290" ], "device_name": "Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile", "medical_specialty_description": "General, Plastic Surgery", "regulation_number": "878.4495", "device_class": "2" } } ] }