{"recall":{"id":"fda-device-99338","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"Medical Action Industries, Inc. 306 recalls Brand Name: Medical Action Industries Product Name: Dialysis Change Tray Clear Sequence Model/Catalog Number: ","firm":"Medical Action Industries, Inc. 306","date":"2026-05-21","reported":"2026-08-12","status":"Ongoing","classification":"Class II","products":[{"name":"Brand Name: Medical Action Industries Product Name: Dialysis Change Tray Clear Sequence Model/Catalog Number: 78791","code":"Lot Code: Lot No.: 327075 328690 319980 320965 318461 322375 325653 330775 331356 336680 UDI: 20809160242558","quantity":"3740 kits (180 cases)","number":"Z-2858-2026","classification":"Class II"}],"reason":"Convenience kits contain needle free access device that has an improper seal which may result in doming or tearing of the silicone seal.","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"US Nationwide distribution in the state of CA.","nationwide":true,"states":[],"units":"3740 kits (180 cases)","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=99338","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"7295b8c2b8e6a2b5","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=99338","record":[{"status":"Ongoing","city":"Arden","state":"NC","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99338","recalling_firm":"Medical Action Industries, Inc. 306","address_1":"25 Heywood Rd","address_2":"","postal_code":"28704-9302","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"E-Mail","distribution_pattern":"US Nationwide distribution in the state of CA.","recall_number":"Z-2858-2026","product_description":"Brand Name: Medical Action Industries   Product Name: Dialysis Change Tray Clear Sequence  Model/Catalog Number: 78791","product_quantity":"3740 kits (180 cases)","reason_for_recall":"Convenience kits contain  needle free access device that has an improper seal which may result in doming or tearing of the silicone seal.","recall_initiation_date":"20260521","center_classification_date":"20260803","report_date":"20260812","code_info":"Lot Code: Lot No.: 327075 328690 319980 320965 318461 322375 325653 330775 331356 336680 UDI: 20809160242558","more_code_info":""}]}}