NanoSight LM10 fitted with LM12 module — Class II medical device recall Z-1761-2022
Ongoing recall by MALVERN PANALYTICAL LTD, reported 2022-10-05, distributed nationwide. Product found to not comply to Class 1 Laser safety requirement.
| Recall number | Z-1761-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | FDA mandated |
| Recalling firm | MALVERN PANALYTICAL LTD, Malvern, N/A, United Kingdom |
| Recall initiated | 2022-02-28 |
| Classified | 2022-09-26 |
| Reported by FDA | 2022-10-05 |
| Distributed | Nationwide (US) |
| Quantity | 111 units |
Product
NanoSight LM10 fitted with LM12 module. A laboratory instrument for determination of particle characteristics (e.g. size).
Reason for recall
Product found to not comply to Class 1 Laser safety requirement.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1761-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.