{"recall":{"id":"fda-device-99698","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"Bayer Medical Care, Inc. recalls MEDRAD¿ Stellant FLEX Syringe Kit used with Stellant FLEX CT Injection System","firm":"Bayer Medical Care, Inc.","date":"2026-07-31","reported":"2026-09-23","status":"Ongoing","classification":"Class II","products":[{"name":"MEDRAD¿ Stellant FLEX Syringe Kit used with Stellant FLEX CT Injection System; Catalog number: FLEXS-150-QFT;","code":"Catalog number: FLEXS-150-QFT; UDI-DI: 00616258022895; Affected material number: 87078825; Affected batch number: 8688750;","quantity":"27800 kits (556 boxes)","number":"Z-3147-2026","classification":"Class II"}],"reason":"Some devices may not have been properly sterilized due to a manufacturing sterilization issue.","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"US Nationwide distribution.","nationwide":true,"states":[],"units":"27800 kits (556 boxes)","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=99698","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"298cdbe77504f254","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=99698","record":[{"status":"Ongoing","city":"Indianola","state":"PA","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99698","recalling_firm":"Bayer Medical Care, Inc.","address_1":"1 Bayer Dr","address_2":"N/A","postal_code":"15051-9702","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Telephone","distribution_pattern":"US Nationwide distribution.","recall_number":"Z-3147-2026","product_description":"MEDRAD¿ Stellant FLEX Syringe Kit used with Stellant FLEX CT Injection System;  Catalog number: FLEXS-150-QFT;","product_quantity":"27800 kits (556 boxes)","reason_for_recall":"Some devices may not have been properly sterilized due to a manufacturing sterilization issue.","recall_initiation_date":"20260731","center_classification_date":"20260911","report_date":"20260923","code_info":"Catalog number: FLEXS-150-QFT; UDI-DI: 00616258022895; Affected material number: 87078825; Affected batch number: 8688750;","more_code_info":""}]}}