FDA 483 - Mercury Enterprises, Inc. dba Mercury Medical - December 11, 2025

An FDA inspection of Mercury Enterprises, Inc. dba Mercury Medical, a medical device manufacturer in Clearwater, FL, revealed significant deficiencies in their quality system. The firm failed to adequately establish corrective and preventive action procedures and incoming product acceptance activities. These failures led to the distribution of defective Neo-Tee T-Piece Resuscitators, resulting in two Class I recalls.