CLASS II ONGOING Device recall · Reported 5 Oct 2022 · FDA Enforcement Report
NanoSight LM10 fitted with LM12 module recalled by Malvern Panalytical
Malvern Panalytical is recalling NanoSight LM10 fitted with LM12 module, distributed nationwide in the US. The recall was initiated on 28 Feb 2022 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1761-2022
- FDA event ID
- 90835
- Recalling firm
- Malvern Panalytical, Malvern, N/A
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 28 Feb 2022
- FDA classified
- 26 Sep 2022
- Reported
- 5 Oct 2022
- Type
- FDA Mandated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 28 Feb 2022 | Recall initiated by company | |
| 26 Sep 2022 | Classified by FDA | +210 days |
| 5 Oct 2022 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Product found to not comply to Class 1 Laser safety requirement.
Product as listed by the FDA
NanoSight LM10 fitted with LM12 module. A laboratory instrument for determination of particle characteristics (e.g. size).
Where it was distributed
US Nationwide Distribution
Questions about this recall
Why was it recalled?
Product found to not comply to Class 1 Laser safety requirement.
Which lots are affected?
CDRH accession # 0510530-001
Where was it sold?
US Nationwide Distribution
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 90835| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | NanoSight LM10 fitted with LM14 module recalled by Malvern Panalytical | Malvern Panalytical | Other | Nationwide |
More recalls from Malvern Panalytical
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | NanoSight LM10 fitted with LM14 module recalled by Malvern Panalytical | Malvern Panalytical | Other | Nationwide |
| Device | CLASS II | NanoSight NS300 recalled by Malvern Panalytical | Malvern Panalytical | Other | Nationwide |
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