{"recall":{"id":"fda-device-99345","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"TISSIUM SA recalls 8 products","firm":"TISSIUM SA","date":"2026-06-15","reported":"2026-08-12","status":"Ongoing","classification":"Class II","products":[{"name":"Brand Name: COAPTIUM Connect Product Name: COAPTIUM Connect Model/Catalog Number: NCOCO1510 Software Version: N/A Product Description: In situ polymerizing peripheral nerve repair device Component: N/A","code":"Lot Code: Model No NCOCO1510; UDI-DI 03760279380070; Lot Numbers 250700041 and 251000032","quantity":"","number":"Z-2901-2026","classification":"Class II"},{"name":"Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number: NCOCO1575 Software Version: N/A Product Description: In situ polymerizing peripheral nerve repair device Component: No","code":"Lot Code: Model No NCOCO1575; UDI-DI ¿03760279380087; Lot Number 250700007, 251000031, and 260300041","quantity":"","number":"Z-2902-2026","classification":"Class II"},{"name":"Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number: NCOCO2010 Software Version: N/A Product Description: In situ polymerizing peripheral nerve repair device Component: No","code":"Lot Code: Model No NCOCO2010; UDI-DI 03760279380094; Lot Number 250700042, 251000033, and 251000034","quantity":"","number":"Z-2903-2026","classification":"Class II"},{"name":"Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number: NCOCO2075 Software Version: N/A Product Description: In situ polymerizing peripheral nerve repair device Component: No","code":"Lot Code: Model No NCOCO2075; UDI-DI ¿03760279380100; Lot Number 250700016, 251000048, 251000049, and 260300043","quantity":"","number":"Z-2904-2026","classification":"Class II"},{"name":"Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number: NCOCO3010 Software Version: N/A Product Description: In situ polymerizing peripheral nerve repair device Component: No","code":"Lot Code: Model No NCOCO3010; UDI-DI 03760279380117; Lot Numbers 250700045, 251000040, 251000036, 251000037, 251000039, 251000035, and 251000064","quantity":"","number":"Z-2905-2026","classification":"Class II"},{"name":"Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number: NCOCO4010 Software Version: N/A Product Description: In situ polymerizing peripheral nerve repair device Component: No","code":"Lot Code: Model No NCOCO4010; UDI-DI 03760279380148; Lot Numbers 251000041, 250700048, 260300046, 260400050, and 260300047","quantity":"","number":"Z-2906-2026","classification":"Class II"},{"name":"Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number: NCOCO5010 Software Version: N/A Product Description: In situ polymerizing peripheral nerve repair device Component: No","code":"Lot Code: Model No NCOCO5010; UDI-DI 03760279380179; Lot Numbers 250700050, 251000043, 260300048, 260300049, and 260300050","quantity":"","number":"Z-2907-2026","classification":"Class II"},{"name":"Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number: NCOCO6010 Software Version: N/A Product Description: In situ polymerizing peripheral nerve repair device Component: No","code":"Lot Code: Model No NCOCO6010; UDI-DI ¿03760279380209; Lot Numbers 250700051, 251000044, and 251000045","quantity":"","number":"Z-2908-2026","classification":"Class II"}],"reason":"Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled to reflect revised shelf life of 26 months. The use of a medical device beyond its validated shelf life may result in perioperative breakage of the device rendering device unusable; worst-case outcome would be revision surgery.","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"US Nationwide distribution in the states of CA, FL, IL, NJ, OH, PA.","nationwide":true,"states":[],"units":"","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=99345","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"2583a27695dcc09c","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=99345","record":[{"status":"Ongoing","city":"Paris 12e Arrondissement","state":"","country":"France","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99345","recalling_firm":"TISSIUM SA","address_1":"74 Rue Du Faubourg Saint-Antoine","address_2":"","postal_code":"N/A","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"US Nationwide distribution in the states of CA, FL, IL, NJ, OH, PA.","recall_number":"Z-2901-2026","product_description":"Brand Name: COAPTIUM Connect  Product Name: COAPTIUM Connect  Model/Catalog Number: NCOCO1510  Software Version: N/A  Product Description: In situ polymerizing peripheral nerve repair device  Component: N/A","product_quantity":"","reason_for_recall":"Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled to reflect revised shelf life of 26 months. The use of a medical device beyond its validated shelf life may result in perioperative breakage of the device rendering device unusable; worst-case outcome would be revision surgery.","recall_initiation_date":"20260615","center_classification_date":"20260806","report_date":"20260812","code_info":"Lot Code: Model No NCOCO1510; UDI-DI 03760279380070; Lot Numbers 250700041 and 251000032","more_code_info":""},{"status":"Ongoing","city":"Paris 12e Arrondissement","state":"","country":"France","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99345","recalling_firm":"TISSIUM SA","address_1":"74 Rue Du Faubourg Saint-Antoine","address_2":"","postal_code":"N/A","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"US Nationwide distribution in the states of CA, FL, IL, NJ, OH, PA.","recall_number":"Z-2902-2026","product_description":"Brand Name: COAPTIUM CONNECT  Product Name: COAPTIUM CONNECT  Model/Catalog Number: NCOCO1575  Software Version: N/A  Product Description: In situ polymerizing peripheral nerve repair device  Component: No","product_quantity":"","reason_for_recall":"Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled to reflect revised shelf life of 26 months. The use of a medical device beyond its validated shelf life may result in perioperative breakage of the device rendering device unusable; worst-case outcome would be revision surgery.","recall_initiation_date":"20260615","center_classification_date":"20260806","report_date":"20260812","code_info":"Lot Code: Model No NCOCO1575; UDI-DI ¿03760279380087; Lot Number 250700007, 251000031, and 260300041","more_code_info":""},{"status":"Ongoing","city":"Paris 12e Arrondissement","state":"","country":"France","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99345","recalling_firm":"TISSIUM SA","address_1":"74 Rue Du Faubourg Saint-Antoine","address_2":"","postal_code":"N/A","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"US Nationwide distribution in the states of CA, FL, IL, NJ, OH, PA.","recall_number":"Z-2903-2026","product_description":"Brand Name: COAPTIUM CONNECT  Product Name: COAPTIUM CONNECT  Model/Catalog Number: NCOCO2010  Software Version: N/A  Product Description: In situ polymerizing peripheral nerve repair device  Component: No","product_quantity":"","reason_for_recall":"Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled to reflect revised shelf life of 26 months. The use of a medical device beyond its validated shelf life may result in perioperative breakage of the device rendering device unusable; worst-case outcome would be revision surgery.","recall_initiation_date":"20260615","center_classification_date":"20260806","report_date":"20260812","code_info":"Lot Code: Model No NCOCO2010; UDI-DI  03760279380094; Lot Number 250700042, 251000033, and 251000034","more_code_info":""},{"status":"Ongoing","city":"Paris 12e Arrondissement","state":"","country":"France","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99345","recalling_firm":"TISSIUM SA","address_1":"74 Rue Du Faubourg Saint-Antoine","address_2":"","postal_code":"N/A","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"US Nationwide distribution in the states of CA, FL, IL, NJ, OH, PA.","recall_number":"Z-2904-2026","product_description":"Brand Name: COAPTIUM CONNECT  Product Name: COAPTIUM CONNECT  Model/Catalog Number: NCOCO2075  Software Version: N/A  Product Description: In situ polymerizing peripheral nerve repair device  Component: No","product_quantity":"","reason_for_recall":"Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled to reflect revised shelf life of 26 months. The use of a medical device beyond its validated shelf life may result in perioperative breakage of the device rendering device unusable; worst-case outcome would be revision surgery.","recall_initiation_date":"20260615","center_classification_date":"20260806","report_date":"20260812","code_info":"Lot Code: Model No NCOCO2075; UDI-DI  ¿03760279380100; Lot Number 250700016, 251000048, 251000049, and 260300043","more_code_info":""},{"status":"Ongoing","city":"Paris 12e Arrondissement","state":"","country":"France","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99345","recalling_firm":"TISSIUM SA","address_1":"74 Rue Du Faubourg Saint-Antoine","address_2":"","postal_code":"N/A","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"US Nationwide distribution in the states of CA, FL, IL, NJ, OH, PA.","recall_number":"Z-2905-2026","product_description":"Brand Name: COAPTIUM CONNECT  Product Name: COAPTIUM CONNECT  Model/Catalog Number: NCOCO3010  Software Version: N/A  Product Description: In situ polymerizing peripheral nerve repair device  Component: No","product_quantity":"","reason_for_recall":"Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled to reflect revised shelf life of 26 months. The use of a medical device beyond its validated shelf life may result in perioperative breakage of the device rendering device unusable; worst-case outcome would be revision surgery.","recall_initiation_date":"20260615","center_classification_date":"20260806","report_date":"20260812","code_info":"Lot Code: Model No NCOCO3010; UDI-DI 03760279380117; Lot Numbers 250700045, 251000040, 251000036, 251000037, 251000039, 251000035, and 251000064","more_code_info":""},{"status":"Ongoing","city":"Paris 12e Arrondissement","state":"","country":"France","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99345","recalling_firm":"TISSIUM SA","address_1":"74 Rue Du Faubourg Saint-Antoine","address_2":"","postal_code":"N/A","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"US Nationwide distribution in the states of CA, FL, IL, NJ, OH, PA.","recall_number":"Z-2906-2026","product_description":"Brand Name: COAPTIUM CONNECT  Product Name: COAPTIUM CONNECT  Model/Catalog Number: NCOCO4010  Software Version: N/A  Product Description: In situ polymerizing peripheral nerve repair device  Component: No","product_quantity":"","reason_for_recall":"Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled to reflect revised shelf life of 26 months. The use of a medical device beyond its validated shelf life may result in perioperative breakage of the device rendering device unusable; worst-case outcome would be revision surgery.","recall_initiation_date":"20260615","center_classification_date":"20260806","report_date":"20260812","code_info":"Lot Code: Model No NCOCO4010; UDI-DI 03760279380148; Lot Numbers 251000041, 250700048, 260300046, 260400050, and 260300047","more_code_info":""},{"status":"Ongoing","city":"Paris 12e Arrondissement","state":"","country":"France","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99345","recalling_firm":"TISSIUM SA","address_1":"74 Rue Du Faubourg Saint-Antoine","address_2":"","postal_code":"N/A","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"US Nationwide distribution in the states of CA, FL, IL, NJ, OH, PA.","recall_number":"Z-2907-2026","product_description":"Brand Name: COAPTIUM CONNECT  Product Name: COAPTIUM CONNECT  Model/Catalog Number: NCOCO5010  Software Version: N/A  Product Description: In situ polymerizing peripheral nerve repair device  Component: No","product_quantity":"","reason_for_recall":"Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled to reflect revised shelf life of 26 months. The use of a medical device beyond its validated shelf life may result in perioperative breakage of the device rendering device unusable; worst-case outcome would be revision surgery.","recall_initiation_date":"20260615","center_classification_date":"20260806","report_date":"20260812","code_info":"Lot Code: Model No NCOCO5010; UDI-DI 03760279380179; Lot Numbers 250700050, 251000043, 260300048, 260300049, and 260300050","more_code_info":""},{"status":"Ongoing","city":"Paris 12e Arrondissement","state":"","country":"France","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99345","recalling_firm":"TISSIUM SA","address_1":"74 Rue Du Faubourg Saint-Antoine","address_2":"","postal_code":"N/A","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"US Nationwide distribution in the states of CA, FL, IL, NJ, OH, PA.","recall_number":"Z-2908-2026","product_description":"Brand Name: COAPTIUM CONNECT  Product Name: COAPTIUM CONNECT  Model/Catalog Number: NCOCO6010  Software Version: N/A  Product Description: In situ polymerizing peripheral nerve repair device  Component: No","product_quantity":"","reason_for_recall":"Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled to reflect revised shelf life of 26 months. The use of a medical device beyond its validated shelf life may result in perioperative breakage of the device rendering device unusable; worst-case outcome would be revision surgery.","recall_initiation_date":"20260615","center_classification_date":"20260806","report_date":"20260812","code_info":"Lot Code: Model No NCOCO6010; UDI-DI ¿03760279380209; Lot Numbers 250700051, 251000044, and 251000045","more_code_info":""}]}}