{"recall":{"id":"fda-device-99593","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"embecta Medical II LLC recalls 2 products","firm":"embecta Medical II LLC","date":"2023-07-26","reported":"2026-09-23","status":"Ongoing","classification":"Class II","products":[{"name":"EWO_02512 (Catalog number 320550) For Investigational Use Only Nano Pro Un-Cannulated Demo Samples Quantity 100","code":"No UDI/All products labeled \"for Investigational Use Only\"","quantity":"4300 Final Count (in EA)","number":"Z-3179-2026","classification":"Class II"},{"name":"EWO_02513 (Catalog number 320122) For Investigational Use Only Nano Un-Cannulated Demo Samples Quantity 100","code":"No UDI/All products labeled \"for Investigational Use Only\"","quantity":"3000 Final Count (in EA)","number":"Z-3180-2026","classification":"Class II"}],"reason":"Retrospectively reported: Pen needles labeled 'For Investigational Use Only' were inadvertently distributed as commercially marketed devices.","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"US Nationwide distribution in the states of MA, KY, CT, TX, NJ, OH, MN, LA, IN, NH, AL, CA, NY, FL, NC, MI, SC, AZ, VA, GA, PA, MO.","nationwide":true,"states":[],"units":"4300 Final Count (in EA); 3000 Final Count (in EA)","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=99593","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"1927c7b5496bc168","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=99593","record":[{"status":"Ongoing","city":"Parsippany","state":"NJ","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99593","recalling_firm":"embecta Medical II LLC","address_1":"300 Kimball Dr Ste 300","address_2":"N/A","postal_code":"07054-2184","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"E-Mail","distribution_pattern":"US Nationwide distribution in the states of MA, KY, CT, TX, NJ, OH, MN, LA, IN, NH, AL, CA, NY, FL, NC, MI, SC, AZ, VA, GA, PA, MO.","recall_number":"Z-3179-2026","product_description":"EWO_02512 (Catalog number 320550)  For Investigational Use Only  Nano Pro Un-Cannulated Demo Samples  Quantity 100","product_quantity":"4300 Final Count (in EA)","reason_for_recall":"Retrospectively reported: Pen needles labeled 'For Investigational Use Only' were inadvertently distributed as commercially marketed devices.","recall_initiation_date":"20230726","center_classification_date":"20260916","report_date":"20260923","code_info":"No UDI/All products labeled \"for Investigational Use Only\"","more_code_info":""},{"status":"Ongoing","city":"Parsippany","state":"NJ","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99593","recalling_firm":"embecta Medical II LLC","address_1":"300 Kimball Dr Ste 300","address_2":"N/A","postal_code":"07054-2184","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"E-Mail","distribution_pattern":"US Nationwide distribution in the states of MA, KY, CT, TX, NJ, OH, MN, LA, IN, NH, AL, CA, NY, FL, NC, MI, SC, AZ, VA, GA, PA, MO.","recall_number":"Z-3180-2026","product_description":"EWO_02513 (Catalog number 320122)  For Investigational Use Only  Nano Un-Cannulated Demo Samples  Quantity 100","product_quantity":"3000 Final Count (in EA)","reason_for_recall":"Retrospectively reported: Pen needles labeled 'For Investigational Use Only' were inadvertently distributed as commercially marketed devices.","recall_initiation_date":"20230726","center_classification_date":"20260916","report_date":"20260923","code_info":"No UDI/All products labeled \"for Investigational Use Only\"","more_code_info":""}]}}