{"recall":{"id":"fda-device-99102","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"Oscor Inc. recalls 3 products","firm":"Oscor Inc.","date":"2026-06-10","reported":"2026-07-22","status":"Ongoing","classification":"Class I","products":[{"name":"Abiomed REF: 0052-3025, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 14F 13cm and 25cm. heart pump and accessories.","code":"All Lots within Expiry/GTIN:00885672009793, 00813502010664","quantity":"355 units","number":"Z-2678-2026","classification":"Class I"},{"name":"Abiomed REF: 0052-3021, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 14F, 23F. heart pump and accessories.","code":"All Lots within Expiry/GTIN:00885672009786/00813502010558","quantity":"1332 units","number":"Z-2679-2026","classification":"Class I"},{"name":"Abiomed REF: 0052-3006, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 23F. heart pump and accessories.","code":"All Lots within Expiry/GTIN:00885672009755/00813502011609","quantity":"32,934 units","number":"Z-2680-2026","classification":"Class I"}],"reason":"Due to manufacturing issues, there is a potential for the 14Fr and 23Fr introducer sheaths to leak from the sidearm, under the sheath cap, and along the hub score lines in the hub region.","hazard":"FDA Class I: a reasonable probability that use or exposure will cause serious adverse health consequences or death (FDA definition).","affected":"Distribution in the US state of MA","nationwide":false,"states":["MA"],"units":"355 units; 1332 units; 32,934 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=99102","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"acc92b85b0ccbb90","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=99102","record":[{"status":"Ongoing","city":"Palm Harbor","state":"FL","country":"United States","classification":"Class I","openfda":{},"product_type":"Devices","event_id":"99102","recalling_firm":"Oscor Inc.","address_1":"4875 Palm Harbor Blvd","address_2":"","postal_code":"34683-1217","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"","distribution_pattern":"Distribution in the US state of MA","recall_number":"Z-2678-2026","product_description":"Abiomed REF: 0052-3025, Introducer Kit for Impella   Hemostatic Peel Away Introducer System with Infusion Sideport, 14F 13cm and 25cm.  heart pump and accessories.","product_quantity":"355 units","reason_for_recall":"Due to manufacturing issues, there is a potential for the 14Fr and 23Fr introducer sheaths to leak from the sidearm, under the sheath cap, and along the hub score lines in the hub region.","recall_initiation_date":"20260610","center_classification_date":"20260710","report_date":"20260722","code_info":"All Lots within Expiry/GTIN:00885672009793, 00813502010664","more_code_info":""},{"status":"Ongoing","city":"Palm Harbor","state":"FL","country":"United States","classification":"Class I","openfda":{},"product_type":"Devices","event_id":"99102","recalling_firm":"Oscor Inc.","address_1":"4875 Palm Harbor Blvd","address_2":"","postal_code":"34683-1217","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"","distribution_pattern":"Distribution in the US state of MA","recall_number":"Z-2679-2026","product_description":"Abiomed REF: 0052-3021, Introducer Kit for Impella   Hemostatic Peel Away Introducer System with Infusion Sideport, 14F, 23F. heart pump and accessories.","product_quantity":"1332 units","reason_for_recall":"Due to manufacturing issues, there is a potential for the 14Fr and 23Fr introducer sheaths to leak from the sidearm, under the sheath cap, and along the hub score lines in the hub region.","recall_initiation_date":"20260610","center_classification_date":"20260710","report_date":"20260722","code_info":"All Lots within Expiry/GTIN:00885672009786/00813502010558","more_code_info":""},{"status":"Ongoing","city":"Palm Harbor","state":"FL","country":"United States","classification":"Class I","openfda":{},"product_type":"Devices","event_id":"99102","recalling_firm":"Oscor Inc.","address_1":"4875 Palm Harbor Blvd","address_2":"","postal_code":"34683-1217","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"","distribution_pattern":"Distribution in the US state of MA","recall_number":"Z-2680-2026","product_description":"Abiomed REF: 0052-3006, Introducer Kit for Impella   Hemostatic Peel Away Introducer System with Infusion Sideport, 23F. heart pump and accessories.","product_quantity":"32,934 units","reason_for_recall":"Due to manufacturing issues, there is a potential for the 14Fr and 23Fr introducer sheaths to leak from the sidearm, under the sheath cap, and along the hub score lines in the hub region.","recall_initiation_date":"20260610","center_classification_date":"20260710","report_date":"20260722","code_info":"All Lots within Expiry/GTIN:00885672009755/00813502011609","more_code_info":""}]}}