Bioventus, LLC: Medical Device Recall in 2021 - (Recall #: Z-0810-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

EXOGEN Ultrasound Coupling Gel

Product Classification:

Class II

Date Initiated: December 17, 2020

Date Posted: January 20, 2021

Recall Number: Z-0810-2021

Event ID: 87002

Reason for Recall:

Product may contain white particulates that are microbial in nature.

Status: Terminated

Product Quantity: 115,584 units

Code Information:

UDI: M937710344001. Part #71034475, Lot # 190235, 200207; Part # 71034694, Lot # 190235, 190263, 200218, 200228; Part # 71034695, Lot # 190235, 200207; Part # 81079892, Lot # 190204, 190211, 190213, 190226, 190228, 190250, 190251, 190252, 200212, 200215, 200227, 200229, 200240; Part # 81087015, Lot # 190215, 190230, 190235T, 200201, 200203, 200212T, 200215T, 200228T, 200240T

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

Voluntary or Mandated:

Voluntary: Firm initiated