Radiation monitoring dosimeter units recalled for potential accuracy defect
Landauer is recalling 147 nanoDot D2DNS radiation dosimeters worldwide due to potential non-conformance in the OSL material that may result in readings falling outside the ±5.5% accuracy specification.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II medical device recall for potential measurement inaccuracy in a safety-critical radiation dosimeter. Although no illness or injury has been reported, the risk-of-harm nature of radiation dose measurement errors warrants a High severity classification.
Plain-English summary
Landauer is recalling 147 nanoDot D2DNS radiation monitoring dosimeters (Model 03033-OTO, UDI/DI 0860003399903) distributed worldwide. These dosimeters are used with microSTAR readers to measure occupational radiation exposure.
The recall stems from a potential non-conformance in the Optical Stimulated Luminescence (OSL) material used in the dosimeters. When exposed to radiation, this material emits fluorescence proportional to the dose received. Investigation revealed that some units may have OSL material that produces measurements falling outside the specified accuracy range of ±5.5%, potentially resulting in inaccurate radiation dose readings.
Workers and facilities using these dosimeters should contact Landauer to determine if their units are affected and for guidance on next steps. The recall encompasses all batch numbers of the affected model.
The recalled product
- Product
- nanoDot D2DNS, for custom calibrate, OTO, Model Number 03033-OTO; radiation monitoring dosimeter used with the microSTAR readers
- Manufacturer
- Landauer
- Hazard
- measurement-error
- accuracy-defect
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI/DI 0860003399903
- all batch numbers
Distribution
Distribution scope not specified by the agency.
Related recalls
Same category
- SevereMedtronic DLP Retrograde Cannula recalled for sterile barrier breach risk
FDA (Devices) · 2026-05-27
- HighAzurion X-ray System Deaeration Hose May Degrade and Cause Oil Leakage
FDA (Devices) · 2026-05-27
- HighSwan-Ganz Jr Catheter models recalled due to lumen hub leakage
FDA (Devices) · 2026-05-27
- SevereMedtronic DLP Retrograde Cannula Recalls for Sterile Barrier Breach Risk
FDA (Devices) · 2026-05-27
- HighMedtronic DLP Retrograde Cannula Cardiopulmonary Bypass Catheter Recall
FDA (Devices) · 2026-05-27