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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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.
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