EXOGEN Ultrasound Coupling Gel
FDA Recall Z-0810-2021 · Posted None
Recalling FirmBioventus, LLC
Recall StatusTerminated
Product CodeLOF
Date Initiated2020-12-17
Date Terminated2024-08-07
Product Quantity115,584 units
Reason for Recall
Product may contain white particulates that are microbial in nature.
Firm Action
Device Recall Notice 3010203571-12/14/20-001-R was sent to customers beginning 12/17/2020. Customers were instructed to dispose of the product and verify disposal lot and quantity.
Root Cause
Nonconforming Material/Component
Distribution Pattern
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
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.