Home / Recalls / Medical Devices
Exact Medical Manufacturing, Inc. recalls Probe Cover 6"x48"- Ultrasonic Transducer Cover Item ID: SH29
Recalled June 30, 2021 · FDA recall Z-1922-2021 · Exact Medical Manufacturing
Hazard
No 510k for the product to be used in a natural or surgical opening to the body · FDA Class II
Units
36000
Sold at
US distribution to states of FL, MT, NY, OH, GA, and Puerto Rico
Description
No 510k for the product to be used in a natural or surgical opening to the body
Product
Probe Cover 6"x48"- Ultrasonic Transducer Cover Item ID: SH29
Manufacturer(s)
Exact Medical Manufacturing, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →