Agency classClass IIOur severity:High FDA (Devices)·Z-2544-2023·Announced 2023-09-20

Landauer nanoDot Radiation Dosimeters Recalled Due to Potential Accuracy Issues

Landauer is recalling 18,638 nanoDot radiation monitoring dosimeters worldwide. Some units may measure radiation exposure outside the specified ±5.5% accuracy range, potentially affecting occupational safety monitoring.

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 3/5 (High).

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: FDA Class II recall of a risk-of-harm medical device where measurement accuracy is essential to worker radiation safety. No illnesses or injuries have been reported; the hazard is real but currently theoretical, fitting the criterion for score 3.

Plain-English summary

Landauer is recalling nanoDot D2DNS radiation monitoring dosimeters (Model Numbers 03057-1MO, 03057-3MO, 03057-OTO, 03057-SMO) due to a potential non-conformance in the Optical Stimulated Luminescence (OSL) material. The issue may cause some dosimeters to read outside the specified ±5.5% accuracy range, meaning radiation exposure measurements may not be reliable.

The recall affects approximately 18,638 units distributed worldwide. Radiation dosimeters are critical tools for monitoring worker exposure in medical, industrial, and research settings. Inaccurate readings could result in workers receiving more radiation exposure than documented, or protection levels being incorrectly recorded.

Facilities using nanoDot dosimeters with the affected model numbers should contact Landauer for instructions. No illnesses or injuries have been reported in connection with this recall.

The recalled product

Product: nanoDot D2DNS, Model Numbers: a) 03057-1MO; b) 03057-3MO; c) 03057-OTO; d) 03057-SMO; radiation monitoring dosimeter used with the microSTAR readers
Manufacturer: Landauer
Category: Medical Device — Radiation Monitoring Equipment
Hazard: measurement-error
radiation-monitoring
Affected units: 18,638

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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High
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Landauer nanoDot D2DXS Dosimeter Recall for Measurement Accuracy
FDA (Devices) · 2023-09-20
High
Landauer nanoDot A Dosimeters Recalled for Potential Measurement Inaccuracy
FDA (Devices) · 2023-09-20
High
Landauer nanoDot dosimeters recalled for potential accuracy deviation
FDA (Devices) · 2023-09-20

Same hazard · measurement error