- Recalling firm
- Heraeus Medical GmbH (Dental Division)
- Reason for recall
- Based 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).
- Affected products (lot / model / serial)
- Material Number: 66057897; UDI-DI: 04260102133617; Batch: all batches with numbers below 520215;
- Units affected
- 1,125 units
- Distribution pattern
- Worldwide 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.;
- Firm location
- Wehrheim, Germany
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- Letter
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-1998-2026
- Recall initiated
- March 25, 2026
- FDA classification date
- April 29, 2026
- FDA report date
- May 6, 2026
- FDA event ID
- 98608
- Last updated on HTM Vibe
- July 24, 2026