The Recall Desk
HighFDA (Devices)·Z-0810-2021·Announced 2021-01-20

Bioventus Recalls EXOGEN Ultrasound Coupling Gel Due to Microbial Particulates

Bioventus is recalling EXOGEN Ultrasound Coupling Gel because it may contain white particulates that are microbial in nature.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device with a potential microbial contamination hazard, which poses a risk of harm, but no specific injuries or illnesses are reported in the source text.

Plain-English summary

Bioventus, LLC is recalling EXOGEN Ultrasound Coupling Gel. The recall is being conducted because the product may contain white particulates that are microbial in nature.

The affected product was distributed in the United States and internationally, including Australia, Austria, Belgium, Canada, Cyprus, Denmark, France, Germany, Hong Kong, Ireland, Italy, Japan, Netherlands, Norway, Poland, South Africa, Spain, Sweden, Switzerland, and the United Kingdom. The recall covers 115,584 units.

Consumers should stop using the product and contact Bioventus for further instructions.

The recalled product

Product
EXOGEN Ultrasound Coupling Gel
Manufacturer
Bioventus, LLC
Category
Medical Device — Ultrasound Gel
Hazard
Affected units
115,584

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • UDI: M937710344001. Part #71034475
  • Lot # 190235
  • 200207
  • Part # 71034694
  • 190263
  • 200218
  • 200228
  • Part # 71034695
  • Part # 81079892
  • Lot # 190204
  • 190211
  • 190213
  • 190226
  • 190228
  • 190250
  • 190251
  • 190252
  • 200212
  • 200215
  • 200227

Distribution

Distributed nationwide across the United States.

Related recalls

Same manufacturer · Bioventus, LLC

See all →

Same hazard · microbial contamination

See all →