Laboratory Instrument Recalled for Class 1 Laser Safety Non-Compliance
Malvern Panalytical is recalling 76 NanoSight LM10 laboratory instruments that do not comply with Class 1 laser safety requirements. The company is taking this action to prevent potential laser exposure risks.
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 for laser safety non-compliance. While no injuries have been reported, laser safety violations represent a risk-of-harm product that could cause serious eye injuries to laboratory personnel, warranting a High severity rating.
Plain-English summary
Malvern Panalytical Ltd. is recalling 76 NanoSight LM10 laboratory instruments fitted with LM14 modules. These instruments are used in laboratory settings to measure particle characteristics such as size.
The instruments were found to not comply with Class 1 laser safety requirements. This non-compliance creates a potential risk of laser exposure to users.
The affected instruments were distributed nationwide in the United States. Laboratory facilities and research institutions that use these instruments may be affected.
Owners of the affected NanoSight LM10 instruments should contact Malvern Panalytical Ltd. immediately for instructions on how to address the laser safety non-compliance. Do not use these instruments until the issue has been resolved.
The recalled product
- Product
- NanoSight LM10 fitted with LM14 module. A laboratory instrument for determination of particle characteristics (e.g. size).
- Manufacturer
- MALVERN PANALYTICAL LTD
- Hazard
- Affected units
- 76
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 (1)
- CDRH accession # 0510530-002
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by MALVERN PANALYTICAL LTD 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 2 products in this recall →Related recalls
Same manufacturer · MALVERN PANALYTICAL LTD
See all →- HighNanoSight particle analyzer recalled for laser safety non-compliance
FDA (Devices) · 2022-10-05
- HighNanoSight NS300 Medical Device Recalled for Laser Safety Noncompliance
FDA (Devices) · 2022-08-10
Same hazard · laser safety
See all →- HighRaman spectrometers recalled over two newly identified laser safety failure modes
FDA (Devices) · 2025-09-17
- HighBodor i Series laser cutting machines fail federal laser safety standards
FDA (Devices) · 2025-07-30
- HighBLS laser show projectors shipped without a working remote interlock connector
FDA (Devices) · 2025-07-23
- HighBLS PURE laser projectors shipped without a working remote interlock connector
FDA (Devices) · 2025-07-23
- HighBLS DIODE laser projectors shipped without a working remote interlock connector
FDA (Devices) · 2025-07-23
Similar recalls
- HighNanoSight NS300 Medical Device Recalled for Laser Safety Noncompliance
FDA (Devices) · 2022-08-10
- HighNanoDots radiation dosimeter recalled for potential measurement accuracy issues
FDA (Devices) · 2023-09-20
- HighLandauer nanoDot radiation dosimeter recalled for potential measurement inaccuracy
FDA (Devices) · 2023-09-20
- HighLandauer NanoDots radiation dosimeters recalled for potential accuracy defect
FDA (Devices) · 2023-09-20
- HighRadiation Dosimeter Kit Recalled Due to Potential Accuracy Drift
FDA (Devices) · 2023-09-20
- HighLandauer nanoDot A Dosimeters Recalled for Potential Measurement Inaccuracy
FDA (Devices) · 2023-09-20