{"recall":{"id":"fda-device-99322","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"SDI Limited recalls Dentsply Sirona Capsule Mixer Model No","firm":"SDI Limited","date":"2026-07-20","reported":"2026-08-26","status":"Ongoing","classification":"Class II","products":[{"name":"Dentsply Sirona Capsule Mixer Model No. 5546068","code":"UDI:9336472005542; Serial Numbers 0003-1533","quantity":"1,444 units","number":"Z-2954-2026","classification":"Class II"}],"reason":"Potential for electrical discharge from unit when unplugged.","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"US: AK\tAL\tAR\tAZ\tCA\tCO\tCT\tDE\tFL\tGA\tHI\tIA\tID\tIL\tIN\tKS\tKY\tLA\tMA\tMD\tME\tMI\tMN\tMO\tMS\tMT\tNC\tNE\tNH\tNJ\tNM\tNV\tNY\tOH\tOK\tOR\tPA\tRI\tSC\tSD\tTN\tTX\tUT\tVA\tVT\tWA\tWI\tWV  OUS: None","nationwide":false,"states":["AK","AL","AR","AZ","CA","CO","CT","DE","FL","GA","HI","IA","ID","IL","IN","KS","KY","LA","MA","MD","ME","MI","MN","MO","MS","MT","NC","NE","NH","NJ","NM","NV","NY","OH","OK","OR","PA","RI","SC","SD","TN","TX","UT","VA","VT","WA","WI","WV"],"units":"1,444 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=99322","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"5aee7313e4d0f152","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=99322","record":[{"status":"Ongoing","city":"Bayswater","state":"","country":"Australia","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99322","recalling_firm":"SDI Limited","address_1":"3-15 Brunsdon St","address_2":"","postal_code":"N/A","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"US: AK\tAL\tAR\tAZ\tCA\tCO\tCT\tDE\tFL\tGA\tHI\tIA\tID\tIL\tIN\tKS\tKY\tLA\tMA\tMD\tME\tMI\tMN\tMO\tMS\tMT\tNC\tNE\tNH\tNJ\tNM\tNV\tNY\tOH\tOK\tOR\tPA\tRI\tSC\tSD\tTN\tTX\tUT\tVA\tVT\tWA\tWI\tWV  OUS: None","recall_number":"Z-2954-2026","product_description":"Dentsply Sirona Capsule Mixer  Model No. 5546068","product_quantity":"1,444 units","reason_for_recall":"Potential for electrical discharge from unit when unplugged.","recall_initiation_date":"20260720","center_classification_date":"20260814","report_date":"20260826","code_info":"UDI:9336472005542; Serial Numbers 0003-1533","more_code_info":""}]}}