Bioventus EXOGEN Ultrasound Gel Recall: Microbial Particulates Hazard
Bioventus recalls EXOGEN Ultrasound Coupling Gel with potential microbial particulates. Affected units include specific part numbers and lots. Consumers should check their product details and contact Bioventus for guidance.
Lower-risk recall
Product may contain white particulates that are microbial in nature.
Contact the company
What happened, in plain English
Bioventus is recalling EXOGEN Ultrasound Coupling Gel due to possible microbial particulates. This could pose a health risk if the gel is used in medical procedures. Affected products have specific part numbers and production lots. Read more at govinfonow.com/recall/63645-bioventus-exogen-ultrasound-gel-recall-microbial-particulates-hazard.
Source Summary by GovInfoNow · govinfonow.com/recall/63645-bioventus-exogen-ultrasound-gel-recall-microbial-particulates-hazard · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0810-2021
Cite this page
“Bioventus EXOGEN Ultrasound Gel Recall: Microbial Particulates Hazard.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63645-bioventus-exogen-ultrasound-gel-recall-microbial-particulates-hazard. Based on FDA recall #Z-0810-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0810-2021%22&limit=1).
Why it’s dangerous
The gel may contain white particulates that are microbial in nature. If these particles enter the body during medical procedures, they could cause infections or other health issues. However, the risk is not immediate and depends on proper use and handling.
Who’s affected
Medical professionals using the EXOGEN Ultrasound Coupling Gel for diagnostic imaging are most at risk. Patients receiving procedures with this gel may also be affected if the product is contaminated.
How to tell if you have this one
Check the product label for part numbers: 71034475, 71034694, 71034695, or 81079892. Also look for specific lots listed in the recall notice, such as 190235 or 200207.
- Brand
Bioventus- Category
Medical device
What to do — step by step
Check Product Details
Review the product label for part numbers and lots to confirm if your EXOGEN Ultrasound Coupling Gel is affected.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA 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” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA terminated this recall 3.6 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
Is this gel safe to use?
The recall states the gel may contain microbial particulates, but it is not immediately unsafe. Affected units should be checked and handled with caution.
Similar recalls
Latest medical device recalls
Keep exploring
Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0810-2021 (December 17, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0810-2021 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.