# FDA recall Z-2092-2025

> **STRATASYS LTD** · Class III · device recall initiated 2024-01-19.

## Product

TrueDent Magenta, TDM130, Model No. OBJ-09166  Light-curable methacrylate-based resin that enables fabrication of dental appliances

## Reason for recall

Customers unable to use cartridges due to formatting error in expiration date which leads to switching the day with the month. Or, the system will not recognize that a resin is expired and will not prevent the user from using an expired material.

## Distribution

US Nationwide distribution including in the states of Arizona, Arkansas, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Maryland, Massachusetts,  Michigan, Nebraska, New York, North Carolina, North Dakota, Oklahoma, Oregon, Utah, Wisconsin.

## Key facts

- **Recall number:** Z-2092-2025
- **Recalling firm:** STRATASYS LTD
- **Classification:** Class III
- **Product type:** device
- **Status:** Completed
- **Initiation date:** 2024-01-19
- **Report date:** 2025-07-16

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Rehovot, N/A, Israel

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2092-2025

## Citation

> AI Analytics. FDA recall Z-2092-2025. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-2092-2025. Source: US FDA. Licensed CC0.

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