How Is FHI Classified?
Ring, Laparotomy is FDA product code FHI, Class 1, 21 CFR 876.4730.
How Does It Reach the US Market?
It is exempt from premarket notification: the manufacturer registers its establishment and lists the device, and no 510(k) is needed before it is sold in the United States.
What Do the Recalls Say?
The FDA has recorded 10 recalls under this product code since 2014. None was by a company in China. 10 are Class I, the most serious grade.
The root cause the FDA records most often is Package design/selection (10). A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.