Landauer NanoDots radiation dosimeters recalled for potential accuracy defect
Landauer is recalling NanoDots radiation monitoring dosimeters worldwide due to potential accuracy defects. Some units may fall outside the specified +/-5.5% accuracy range.
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 FDA Class II recall involves potential accuracy defects in radiation monitoring devices with no reported illnesses or injuries. The hazard is theoretical—a dosimeter outside the specified accuracy range poses a risk of inaccurate radiation dose measurements—satisfying the rubric criterion for high-risk products without confirmed harm.
Plain-English summary
Landauer is recalling approximately 18,333 NanoDots radiation monitoring dosimeters that were distributed worldwide. These devices are used with microSTAR readers to monitor radiation exposure.
The recall was initiated following reports indicating that some NanoDots may fall outside the specified accuracy range of +/-5.5%. An investigation identified a potential non-conformance in the Optical Stimulated Luminescence (OSL) material, which is responsible for measuring radiation exposure by emitting fluorescence proportional to the dose received.
Hospitals, clinics, and healthcare workers using these dosimeters should contact Landauer for further guidance on verification, replacement, or return. Affected units can be identified using the product UDI/DI code 0860003399903, which applies to all batch numbers.
The recalled product
- Product
- NanoDots, Model Numbers: a) BC30023, description: QC Set For Microstar Dots; b) BC30083, description: nanoDot QC Set - 80kVp - Sale; c) BC30084, description: nanoDot QC Set - 80kVp - No Charge; d) BC30088, description: nanoDot Calibration Set - 80kVp - No Charge; e
- Manufacturer
- Landauer
- Hazard
- measurement-accuracy-defect
- radiation-exposure-risk
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.
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