{"url_path":"/fda/device/recalls/Z-1997-2026","section_key":"summary","section_title":"DEVICE Recall: Heraeus Medical GmbH (Dental Division) — Heraeus, PALAMIX uno. Material Number: 66057893.","topic":"fda","document":{"doc_type":"device-recall","doc_date":"2026-03-25","source_url":"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1997-2026%22","accession_number":null,"cik":null,"ticker":null,"issuer_name":null,"edgar_url":null,"primary_entity_key":null,"primary_entity_name":"Heraeus Medical GmbH (Dental Division)"},"word_count":168,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-1997-2026\n\n**Recalling firm:** Heraeus Medical GmbH (Dental Division)\n**Classification:** Class III\n**Status:** Ongoing\n**Type:** Voluntary: Firm initiated\n**Initiated:** 2026-03-25\n**Report date:** 2026-05-06\n\n## Product\nHeraeus, PALAMIX uno. Material Number: 66057893.\n\n## Reason\nBased on long-term stability testing, it was determined that in units older than 1.5 years (17 months) the mixing rod may, in rare cases, come loose from its lock during the mixing process. Notification is to reduce the shelf life from 3 years to 1.5 years (17 months).\n\n## Affected lots\nMaterial Number: 66057893; UDI-DI: 04260102133587; Batch: all batches with numbers below 223060;\n\n## Distribution\nWorldwide distribution - US Nationwide and the countries of Aland Islands, Algeria, Australia, Austria, Belgium, Brazil , Chile, China, Cyprus, Czech Republic, Denmark, Ecuador, Finland, France, Germany, Greece, Hungary, India, Ireland, Israel, Italy, Kosovo, Lithuania, Luxembourg, Malaysia, Malta, Mexico, Netherlands, Nigeria, Norway, Peru, Philippines, Poland, Portugal, Puerto Rico, Rep. of Korea, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Thailand, United Kingdom, Uruguay, Utd.Arab Emir.;"}