Bowen

Defendant repairs the SteriSafe Hand-piece Sterilizer (SteriSafe), which is used to sterilize dental handpieces. He also manufactures the SteriDot High Purity Water Ampule (SteriDot), an accessory used with SteriSafe. The government brought this action, claiming that both products are adulterated in violation of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. § 301 et seq., and that SteriDot also is misbranded in violation of the FFDCA. The district court agreed and enjoined defendant from introducing into, or receiving from, interstate commerce any SteriSafes or SteriDots. The district court also authorized the Food and Drug Administration (FDA) to order defendant to recall all such products that he had produced or repaired.

*684 Defendant appeals, arguing that: (1) the district court erred by holding that these products are “devices” within the meaning of the FFDCA, (2) the FDA acted arbitrarily and capriciously by classifying Ster-iSafe as a class III device subject to pre-market approval, (3) the district court abused its discretion by failing to dismiss the action because of the government’s failure to join a purportedly indispensable party, and (4) the district…