# FDA recall Z-1998-2026

> **Heraeus Medical GmbH (Dental Division)** · Class III · device recall initiated 2026-03-25.

## Product

Heraeus, PALAMIX duo. Material Number: 66057897.

## 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).

## Distribution

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.;

## Key facts

- **Recall number:** Z-1998-2026
- **Recalling firm:** Heraeus Medical GmbH (Dental Division)
- **Classification:** Class III
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-03-25
- **Report date:** 2026-05-06

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Wehrheim, Germany

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1998-2026

## Citation

> AI Analytics. FDA recall Z-1998-2026. Retrieved 2026-06-13 from https://api.ai-analytics.org/recall/Z-1998-2026. Source: US FDA. Licensed CC0.

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