{ "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": "2026-08-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "151117", "product_res_number": "Z-0764-2017", "event_date_initiated": "2016-11-18", "event_date_created": "2016-12-14", "recall_status": "Terminated", "event_date_terminated": "2017-11-24", "res_event_number": "75735", "product_code": "GDT", "product_description": "WECK Visistat 35W, Disposable Skin Stapler, Rx Only, Sterile, Teleflex Medical, NC 27709.\n\nThe intended use of the Visistat stapler is to close lacerations on the outer layer of the dermis for a wide range of general, thoracic, obstetric, gynecological, orthopedic, cardiovascular, urological, and plastic surgical procedures.", "code_info": "Product Code: 528235, Lot numbers: 73C1600693, 73G1500681, 73H1500255, 73H1500256, 73K1500618, 73L1400006 and 73M1500130.", "firm_fei_number": "3005747797", "recalling_firm": "Teleflex Medical", "address_1": "2917 Weck Dr", "city": "Research Triangle Park", "state": "NC", "postal_code": "27709-0186", "additional_info_contact": "Alice Harper\n610-378-0131", "reason_for_recall": "Sterility Deficiency: The packages are not sealed properly and thus the sterility is not assured.", "root_cause_description": "Packaging process control", "action": "The firm, Telexflex Medical, sent an \"URGENT MEDICAL DEVICE RECALL NOTIFICATION\" letter dated 11/18/2016 to its Consignees/Customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately discontinue use and quarantine any affected products; complete and return the Recall Acknowledgement Form by fax to 1-855-419-8507, Attn: Customer Service or email to: recalls@teleflex.com (even if you do not have any affected product) and return the product with the completed Recall Acknowledgement Form. A customer service representative will contact you with a RGA # and provide instructions for the return of the product.\n\nIf you have any other questions, feel free to contact your local sales\nrepresentative or Customer Service at 1-866-246-6990.", "product_quantity": "96,402 units (9,120 ea US, 87,282 ea OUS)", "distribution_pattern": "Worldwide Distribution- U.S. (Nationwide) and countries of: Australia, Belgium, Canada, China, Germany, Hong Kong, India, Japan, Korea, Malaysia, New Zealand, Singapore and Thailand.", "openfda": { "k_number": [ "K822365", "K844838", "K915430", "K821024", "K760734", "K832709", "K800535", "K911204", "K925526", "K844837", "K833357", "K861711", "K900486", "K833085", "K910586", "K851974", "K963234", "K943719", "K801444" ], "registration_number": [ "1222274", "3042272797", "3015453963", "1060680", "3013388519", "1058584", "3010889742", "3013298431", "9616916", "1417592", "3015183635", "3013783488", "3014479313", "1423662", "1720747", "3012448339", "1123010", "9610849", "9681540", "3007421149", "3041276890", "3034669683", "2647580", "3031184338", "3002692886", "3007518347", "9612501", "3014276972", "1721686", "3013846070", "3018094310", "2648727", "3003898360", "3004111573", "3011767135", "3031757047", "3005075853", "1527736", "9616088", "3007222388", "1220477", "1000175697", "1018470", "1320894", "3014023545", "9680284", "3003639970", "3017636737", "3031841433", "1219930", "3030733800", "3015185328", "8040510", "3008496560", "3012494290", "3017210488", "3012421607", "3006517627", "3008693658", "9680721", "1313525", "8022787", "3004824601", "3007205024", "3032391", "3045058049", "3032747418", "1423537", "3003877407", "3008388437", "1043214", "1836161", "3010131137", "3013187142", "3003431869", "3007092328", "3029995792", "3015173212", "1061124", "3013557562", "3012261738", "9611024", "3004488394", "3015859709", "3016994953", "3013188547", "1055236", "1932180", "8040278", "3003866267", "3007791573", "3016426842", "1420054", "3006210673", "3024021261", "3021477808", "3006897996", "1928237", "1319639", "9680794", "1054241", "3007748793", "3011137372", "2320762", "3009380063", "3016248634", "3010605922" ], "fei_number": [ "3042272797", "3015453963", "1000138054", "3002902735", "1000219637", "3005747797", "3000321209", "3013388519", "3001236905", "3010889742", "3013298431", "1000208624", "1417592", "3015183635", "3013783488", "3014479313", "3003040625", "3002807391", "1720747", "3012448339", "3002807170", "3007421149", "3041276890", "3034669683", "2647580", "3004216008", "3031184338", "3002692886", "3007518347", "3014276972", "3002750084", "1721686", "3013846070", "3018094310", "2648727", "3003898360", "3004111573", "6425", "3011767135", "3031757047", "3001319476", "3005075853", "1527736", "3007222388", "1220477", "1000175697", "1018470", "3014023545", "3003639970", "3017636737", "3031841433", "1219930", "3030733800", "3015185328", "3003495548", "1000121057", "3008496560", "3012494290", "3017210488", "3012421607", "3006517627", "3008693658", "3004824601", "3007205024", "3045058049", "1000123297", "3032747418", "3003877407", "3008388437", "1043214", "1000112968", "3010131137", "1000119305", "3003737899", "3013187142", "1000512168", "3003431869", "3000215273", "3004609547", "3007092328", "3029995792", "3015173212", "3013557562", "3012261738", "3004488394", "3015859709", "3016994953", "3013188547", "1000112877", "3003866267", "3007791573", "3016426842", "1420054", "3006210673", "3002299608", "3024021261", "3021477808", "3006897996", "1928237", "1000244733", "1317628", "3007748793", "3002809016", "3009380063", "3016248634", "3001451571", "3010605922" ], "device_name": "Staple, Removable (Skin)", "medical_specialty_description": "General, Plastic Surgery", "regulation_number": "878.4760", "device_class": "1" } } ] }