Reported Jan 20, 2021 · Terminated

EXOGEN Ultrasound Coupling Gel

Bioventus, LLC

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Bioventus, LLC · 1900 Charles Bryan Rd Ste 275 · Cordova, TN · 38016-5285

Is this the product you have?

  • EXOGEN Ultrasound Coupling Gel
Lot codes and dates

5 of 5 products

Products covered by this recall
Model / numberProduct as published
71034475M937710344001. , Lot # 190235, 200207
71034694Lot # 190235, 190263, 200218, 200228
71034695Lot # 190235, 200207
81079892Lot # 190204, 190211, 190213, 190226, 190228, 190250, 190251, 190252, 200212, 200215, 200227, 200229, 200240
81087015Lot # 190215, 190230, 190235T, 200201, 200203, 200212T, 200215T, 200228T, 200240T
Amount recalled
115,584 units

Where it was sold

  • Nationwide

Why it was recalled

Product may contain white particulates that are microbial in nature.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Aug 7, 2024 · Data as of Sep 19, 4:54 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.