- Recalling firm
- Heraeus Medical GmbH (Dental Division)
- Reason for recall
- Potential for monomer liquid leakage.
- Affected products (lot / model / serial)
- Lot Code: UDI-DI: 04260102136243; 04260102136274. All Batch Numbers. All Lot Numbers.
- Units affected
- 20,523 units
- Distribution pattern
- Worldwide distribution - US Nationwide and the countries of Aland Islands, Australia, Austria, Belgium, Denmark, Finland, Germany, Greece, Ireland, Italy, Japan, Liechtenstein, Malta, Netherlands, New Zealand, Norway, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland, United Kingdom.
- Firm location
- Wehrheim, Germany
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- E-Mail
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-3303-2026
- Recall initiated
- August 20, 2026
- FDA classification date
- September 25, 2026
- FDA report date
- October 7, 2026
- FDA event ID
- 99708
- Last updated on HTM Vibe
- October 13, 2026
