CLASS III Device recall · Reported 16 Jul 2025 · FDA Enforcement Report

TrueDent White, TDM110 recalled by Stratasys

Stratasys is recalling TrueDent White, TDM110, distributed nationwide in the US. The recall was initiated on 19 Jan 2024 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codesUDI-DI 7290018915202 Lot 22377 (exp. 12-Oct-2023)

Quantity recalled109

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2094-2025
FDA event ID: 97021
Recalling firm: Stratasys, Rehovot, N/A
Classification: Class III
Status: Completed
Recall initiated: 19 Jan 2024
FDA classified: 7 Jul 2025
Reported: 16 Jul 2025
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Dental Devices

Timeline

19 Jan 2024	Recall initiated by company
7 Jul 2025	Classified by FDA	+535 days
16 Jul 2025	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

TrueDent White, TDM110, Model No. OBJ-09168 Light-curable methacrylate-based resin that enables fabrication of dental appliances

Where it was distributed

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.

Nationwide Arkansas Arizona California Colorado Connecticut Florida Georgia Illinois Indiana Massachusetts Maryland Michigan North Carolina North Dakota Nebraska New York Oklahoma Oregon Utah Wisconsin

Questions about this recall

Why was it recalled?

Which lots are affected?

UDI-DI 7290018915202 Lot 22377 (exp. 12-Oct-2023)

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class III mean?

Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

4 other products · FDA event 97021

This product is part of a recall event; the main page for the event is TrueDent Clear, TDM recalled by Stratasys.

Reported	Class	Recall	Company	Reason	Where
16 Jul 2025	CLASS III	TrueDent Clear, TDM recalled by Stratasys	Stratasys	Other	Nationwide
16 Jul 2025	CLASS III	TrueDent Yellow, TDM140 recalled by Stratasys	Stratasys	Other	Nationwide
16 Jul 2025	CLASS III	TrueDent Cyan, TDM recalled by Stratasys	Stratasys	Other	Nationwide
16 Jul 2025	CLASS III	TrueDent Magenta, TDM130 recalled by Stratasys	Stratasys	Other	Nationwide

More recalls from Stratasys

All 5

Reported	Class	Recall	Company	Reason	Where
16 Jul 2025Device	CLASS III	TrueDent Magenta, TDM130 recalled by Stratasys	Stratasys	Other	Nationwide
16 Jul 2025Device	CLASS III	TrueDent Cyan, TDM recalled by Stratasys	Stratasys	Other	Nationwide
16 Jul 2025Device	CLASS III	TrueDent Yellow, TDM140 recalled by Stratasys	Stratasys	Other	Nationwide
16 Jul 2025Device	CLASS III	TrueDent Clear, TDM recalled by Stratasys	Stratasys	Other	Nationwide

Other Dental Devices recalls

All 426

Reported	Class	Recall	Company	Reason	Where
2 Sep 2026Device	CLASS II	Grandio Universal Nano-Hybrid Restorative Material - Capsules 0.25Gm recalled	Henry Schein	Packaging Defects	Nationwide
19 Aug 2026Device	CLASS II	GM Helix Implant, Endosseous Dental Implant Article No. recalled	Straumann USA	Packaging Defects	Nationwide
15 Jul 2026Device	CLASS II	KL Owen Custom Orthodontic Solution recalled by Klowen Braces	Klowen Braces	Device Malfunction	Nationwide
6 May 2026Device	CLASS II	Straumann n!ce PMMA Full-arch Restoration recalled	Straumann USA	Other	8 states
6 May 2026Device	CLASS II	Straumann n!ce Zr, HT, Full-arch Restoration recalled	Straumann USA	Other	8 states