CLASS II ONGOING Device recall · Reported 10 Aug 2022 · FDA Enforcement Report
NanoSight NS300 recalled by Malvern Panalytical
Malvern Panalytical is recalling NanoSight NS300, distributed nationwide in the US. The recall was initiated on 7 Apr 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-1442-2022
- FDA event ID
- 90597
- Recalling firm
- Malvern Panalytical, Malvern, N/A
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 7 Apr 2022
- FDA classified
- 1 Aug 2022
- Reported
- 10 Aug 2022
- Type
- FDA Mandated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 7 Apr 2022 | Recall initiated by company | |
| 1 Aug 2022 | Classified by FDA | +116 days |
| 10 Aug 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 NS300
Where it was distributed
US Nationwide - Worldwide Distribution
Questions about this recall
Is NanoSight NS300 recalled?
Yes. Malvern Panalytical recalled NanoSight NS300 on 7 Apr 2022. The recall is Class II and its status is Ongoing. Recall number Z-1442-2022.
Why was it recalled?
Product found to not comply to Class 1 Laser safety requirement.
Which lots are affected?
CDRH accession #0510530-003
Where was it sold?
US Nationwide - Worldwide 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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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 LM10 fitted with LM12 module recalled by Malvern Panalytical | Malvern Panalytical | Other | Nationwide |
Other Other Medical Devices recalls
All 13,778| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Citric Complete Dry Citric Acid Concentrate recalled | Nipro Renal Soultions USA | Other | Nationwide |
| Device | CLASS I | Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | Halyard IV Start Kit Non-Sterile recalled by Avid Medical | Avid Medical | Sterility | Nationwide |
| Device | CLASS I | Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | AMS Convenience Kit: Dsaek Pack - RX recalled | Windstone Medical Packaging | Device Malfunction | Nationwide |