Agency classClass IIOur severity:Moderate FDA (Devices)·Z-2569-2023·Announced 2023-09-20

Radiation monitoring dosimeters recalled for potential measurement inaccuracy

Landauer is recalling QC (Cs-137) nanoDot D2DNS radiation dosimeters worldwide because some units may operate outside the specified accuracy range. The recall affects 10,741 units with all batch numbers.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: FDA Class II with no reported illnesses, injuries, or actual exposure incidents. The defect is measurement inaccuracy in a safety-monitoring device—a precautionary quality issue rather than a direct physical hazard.

Plain-English summary

Landauer is recalling the QC (Cs-137) nanoDot D2DNS radiation monitoring dosimeter, including model numbers 18135-000, 18135-KIT, and 18135-SET. These devices measure occupational radiation exposure using Optical Stimulated Luminescence (OSL) technology. The recall applies to all batch numbers and affects 10,741 units distributed worldwide.

Landauer received reports indicating that some nanoDots may operate outside the manufacturer's specified accuracy range of ±5.5%. Investigation identified a potential non-conformance in the OSL material used by the dosimeters, which could result in inaccurate radiation exposure readings.

This recall affects organizations and individuals worldwide that rely on these dosimeters for radiation exposure monitoring and occupational safety assessments.

The recalled product

Product: QC (Cs-137) nanoDot D2DNS, Model Numbers: a) 18135-000; b) 18135-KIT; c) 18135-SET; radiation monitoring dosimeter used with the microSTAR readers
Manufacturer: Landauer
Category: Medical Device — Radiation dosimetry
Hazard: measurement-inaccuracy
occupational-radiation-exposure
Affected units: 10,741

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.

Part of a larger recall action

This product is one of 38 recalled by Landauer under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 38 products in this recall →

Same manufacturer · Landauer

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FDA (Devices) · 2024-03-27
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FDA (Devices) · 2024-01-03
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Landauer nanoDot D2DXS Dosimeter Recall for Measurement Accuracy
FDA (Devices) · 2023-09-20
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Landauer nanoDot A Dosimeters Recalled for Potential Measurement Inaccuracy
FDA (Devices) · 2023-09-20
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Landauer nanoDot Radiation Dosimeters Recalled Due to Potential Accuracy Issues
FDA (Devices) · 2023-09-20

Same hazard · measurement inaccuracy