{"url_path":"/fda/device/recalls/Z-2954-2026","section_key":"summary","section_title":"DEVICE Recall: SDI Limited — Dentsply Sirona Capsule Mixer  Model No. 5546068","topic":"fda","document":{"doc_type":"device-recall","doc_date":"2026-07-20","source_url":"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2954-2026%22","accession_number":null,"cik":null,"ticker":null,"issuer_name":null,"edgar_url":null,"primary_entity_key":null,"primary_entity_name":"SDI Limited"},"word_count":102,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-2954-2026\n\n**Recalling firm:** SDI Limited\n**Classification:** Class II\n**Status:** Ongoing\n**Type:** Voluntary: Firm initiated\n**Initiated:** 2026-07-20\n**Report date:** 2026-08-26\n\n## Product\nDentsply Sirona Capsule Mixer  Model No. 5546068\n\n## Reason\nPotential for electrical discharge from unit when unplugged.\n\n## Affected lots\nUDI:9336472005542; Serial Numbers 0003-1533\n\n## Distribution\nUS: 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"}