EXOGEN Ultrasound Coupling Gel
Reported: January 20, 2021 Initiated: December 17, 2020 #Z-0810-2021
Product Description
EXOGEN Ultrasound Coupling Gel
Reason for Recall
Product may contain white particulates that are microbial in nature.
Details
- Recalling Firm
- Bioventus, LLC
- Units Affected
- 115,584 units
- 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
- Location
- Cordova, TN
Frequently Asked Questions
What product was recalled? ▼
EXOGEN Ultrasound Coupling Gel. Recalled by Bioventus, LLC. Units affected: 115,584 units.
Why was this product recalled? ▼
Product may contain white particulates that are microbial in nature.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 20, 2021. Severity: Moderate. Recall number: Z-0810-2021.
Related Recalls
FDA Devices Moderate
Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.2…
Vortex Surgical Inc. · 2026-02-11
FDA Devices Moderate
COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conju…
Beckman Coulter, Inc. · 2026-02-11
FDA Devices Moderate
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 Product Description: These inst…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0330 Product Description: These in…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not Applicable Produc…
Fujirebio Diagnostics, Inc. · 2026-02-11