FDA Medical Device Recalls (openFDA)
Bioventus, LLC: EXOGEN Ultrasound Coupling Gel
- Recall number
- Z-0810-2021
- Recalling firm
- Bioventus, LLC
- Product
- EXOGEN Ultrasound Coupling Gel
- Status
- Terminated
- Initiated
- 2020-12-17
- Posted
- not on file
- Terminated
- 2024-08-07
- Reason
- Product may contain white particulates that are microbial in nature.
- Root cause
- Nonconforming Material/Component
- Action
- Device Recall Notice 3010203571-12/14/20-001-R was sent to customers beginning 12/17/2020. Customers were instructed to dispose of the product and verify disposal lot and quantity.
- Quantity
- 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
- Lot, serial or model codes
- UDI: M937710344001. Part #71034475, Lot # 190235, 200207; Part # 71034694, Lot # 190235, 190263, 200218, 200228; Part # 71034695, Lot # 190235, 200207; Part # 81079892, Lot # 190204, 190211, 190213, 190226, 190228, 190250, 190251, 190252, 200212, 200215, 200227, 200229, 200240; Part # 81087015, Lot # 190215, 190230, 190235T, 200201, 200203, 200212T, 200215T, 200228T, 200240T
- 510(k) numbers
- not on file
- PMA numbers
- ["P900009"]
- Product code
- LOF
- Firm FEI
- 3027669735
- Firm city
- Cordova
- Firm state
- TN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28