TrueDent Cyan — Class III medical device recall Z-2091-2025
Completed recall by STRATASYS LTD, reported 2025-07-16, distributed nationwide. Customers unable to use cartridges due to formatting error in expiration date which leads to switching the day
| Recall number | Z-2091-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Completed |
| Voluntary or mandated | Voluntary |
| Recalling firm | STRATASYS LTD, Rehovot, N/A, Israel |
| Recall initiated | 2024-01-19 |
| Classified | 2025-07-07 |
| Reported by FDA | 2025-07-16 |
| Distributed | Nationwide (US) |
| Quantity | 100 |
| UPC / GTIN / UDI-DI | 07290018915400 |
| Lot numbers | 23485 |
| Model numbers | OBJ-09165 |
| Expiration dates | 2024-02-09, 2024-11-08 |
Product
TrueDent Cyan, TDM 120, Model No. OBJ-09165 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2091-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.