STRATASYS LTD: Medical Device Recall in 2025 - (Recall #: Z-2091-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

TrueDent Cyan, TDM 120, Model No. OBJ-09165 Light-curable methacrylate-based resin that enables fabrication of dental appliances

Product Classification:

Class III

Date Initiated: January 19, 2024

Date Posted: July 16, 2025

Recall Number: Z-2091-2025

Event ID: 97021

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.

Status: Completed

Product Quantity: 100

Code Information:

UDI-DI 7290018915400 Lots 23485 (exp. 08-Nov-2024) and 22904 (exp. 09-Feb-2024)

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated