{"recall":{"id":"fda-device-99264","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"BD SWITZERLAND SARL recalls 60 In Non-DEHP Minibore Extension Set RES ME2010 UDI-DI code: 10885403236235 MaxPlus Ext Set w/Needleless and ","firm":"BD SWITZERLAND SARL","date":"2026-06-16","reported":"2026-08-19","status":"Ongoing","classification":"Class II","products":[{"name":"60 In Non-DEHP Minibore Extension Set RES ME2010 UDI-DI code: 10885403236235 MaxPlus Ext Set w/Needleless and Y-Site REF MPX5305-C UDI-DI code: 10885403274619 9 IN Extension Set w/Max Y REF MPX5300-C UDI-DI code: 10885403237218 Intravascular Administration Set and Extension Set used to administer fluids.","code":"60 In Non-DEHP Minibore Extension Set RES ME2010 UDI-DI code: 10885403236235 Lot Number: 26025260 MaxPlus Ext Set w/Needleless and Y-Site REF MPX5305-C UDI-DI code: 10885403274619 Lot Number: 26035455 9 IN Extension Set w/Max Y REF MPX5300-C UDI-DI code: 10885403237218 Lot Number: 26055528","quantity":"93,700","number":"Z-2941-2026","classification":"Class II"}],"reason":"Products may not have received adequate sterilization processing.","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"U.S.: AZ, CA, CO, FL, GA, IL, IN, KS, MD, MI, MN, MO, MS, NC, NV, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA  O.U.S.: Canada","nationwide":false,"states":["AZ","CA","CO","FL","GA","IL","IN","KS","MD","MI","MN","MO","MS","NC","NV","NY","OH","OK","OR","PA","SD","TN","TX","UT","VA","WA"],"units":"93,700","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=99264","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"88bef10623e06bec","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=99264","record":[{"status":"Ongoing","city":"Eysins","state":"","country":"Switzerland","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99264","recalling_firm":"BD SWITZERLAND SARL","address_1":"Terre Bonne Park A4","address_2":"Route De Crassier 17","postal_code":"N/A","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"U.S.: AZ, CA, CO, FL, GA, IL, IN, KS, MD, MI, MN, MO, MS, NC, NV, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA  O.U.S.: Canada","recall_number":"Z-2941-2026","product_description":"60 In Non-DEHP Minibore Extension Set RES ME2010  UDI-DI code: 10885403236235   MaxPlus Ext Set w/Needleless and Y-Site REF MPX5305-C  UDI-DI code: 10885403274619   9 IN Extension Set w/Max Y REF MPX5300-C  UDI-DI code: 10885403237218   Intravascular Administration Set and Extension Set used to administer fluids.","product_quantity":"93,700","reason_for_recall":"Products may not have received adequate sterilization processing.","recall_initiation_date":"20260616","center_classification_date":"20260813","report_date":"20260819","code_info":"60 In Non-DEHP Minibore Extension Set RES ME2010 UDI-DI code: 10885403236235 Lot Number: 26025260  MaxPlus Ext Set w/Needleless and Y-Site REF MPX5305-C UDI-DI code: 10885403274619 Lot Number: 26035455  9 IN Extension Set w/Max Y REF MPX5300-C UDI-DI code: 10885403237218 Lot Number: 26055528","more_code_info":""}]}}