What Is It?
High level disinfection of reusable, heat-sensitive devices If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
What Is FDA Product Code NZA?
Accessories, Germicide, Cleaning, For Endoscopes is FDA product code NZA, Class 2, 21 CFR 876.1500.
How Does It Reach the US Market?
A 510(k) premarket notification is required before it is sold in the United States: the applicant shows the device is substantially equivalent to one already on the market. No clearance under this code names a Chinese applicant. A registration is not a clearance: the plants above are set up to make it, and the 510(k) it is sold under is held by whoever files it, often the brand.
What Do the Recalls Say?
The FDA has recorded 1 recall under this product code since 2013. None was by a company in China. The root cause the FDA records most often is Use error (1).
A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.