Z-1442-2022Class II

NanoSight NS300

Name: Z-1442-2022 NanoSight NS300
Creator: Malvern Panalytical Ltd
Published: 2022-04-07
License: https://open.fda.gov/license/

Malvern Panalytical Ltd / initiated 2022-04-07 / Open, Classified

FDA source

MALVERN PANALYTICAL LTD began a recall of NanoSight NS300 on 2022-04-07. FDA classified it as Class II and gives the reason as "Product found to not comply to Class 1 Laser safety requirement". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1442-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-04-07
Posted: 2022-08-01
Recalling firm: Malvern Panalytical Ltd
Product: NanoSight NS300
Product code: REN Particle-Size Measuring Instrument
Reason for recall: Product found to not comply to Class 1 Laser safety requirement.
FDA root cause: Radiation Control for Health and Safety Act
Action: Customers are being made aware of this issue. All affected customers will be provided with a remediation kit with Class 3R labels and manual addenda with revised safety instructions.
Quantity in commerce: 507 units
Distribution: US Nationwide - Worldwide Distribution
Product codes and lots: CDRH accession #0510530-003

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1442-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1442-2022	Class II	Ongoing	FDA Mandated	2022-08-10	2022-08-01

Product code REN

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)