FDA recall Z-0810-2021

Product

EXOGEN Ultrasound Coupling Gel

Reason for recall

Product may contain white particulates that are microbial in nature.

Distribution

United States (Nationwide), Australia, Austria, Belgium, Canada, Cyprus, Denmark, France, Germany, Hong Kong, Ireland, Italy, Japan, Netherlands, Norway, Poland, South Africa, Spain, Sweden, Switzerland, United Kingdom

Key facts

Status

Terminated

Initiation date

2020-12-17

Report date

2021-01-20

Termination date

2024-08-07

Voluntary/Mandated

Voluntary: Firm initiated

Location

Cordova, TN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0810-2021