FDA Medical Device Recalls (openFDA)
Biocompatibles U.K., Ltd.: TheraSphere(R) YTTRIUM-90 CLASS MICROSPHERE INJECTION TheraSphere is indicated for radiation treatment or as a neoadjuvant to surgery or transplantation in patients with unresectable HCC who can have placement of appropriately positioned hepatic arterial catheters.
- Recall number
- Z-0078-2017
- Recalling firm
- Biocompatibles U.K., Ltd.
- Product
- TheraSphere(R) YTTRIUM-90 CLASS MICROSPHERE INJECTION TheraSphere is indicated for radiation treatment or as a neoadjuvant to surgery or transplantation in patients with unresectable HCC who can have placement of appropriately positioned hepatic arterial catheters.
- Status
- Terminated
- Initiated
- 2015-09-21
- Posted
- not on file
- Terminated
- 2016-10-17
- Reason
- One mislabeled dose of TheraSphere Y-90 Glass Microspheres, which was shipped to Hong Kong (total radioactivity incorrect). The product ws labeled as 10 GBq and the actual does was 5 GBq.
- Root cause
- Packaging
- Action
- Biocompatibles UK Ltd sent an Urgent Field Safety Notice dated September 21, 2015, to all affected customers. The firm did not request return or destruction of the product. Customers with questions were instructed to call 613-410-1870. For questions regarding this recall call 613-801-1848.
- Quantity
- 64 doses
- Distribution
- Worldwide Distribution - US to CA, FL, IL, WI, IN, OR, PA, MA, NY, KY, TX, MI, MD, NV, WA, OH, MN, and Internationally to Germany, Turkey, Hong Kong, Italy, Portugal
- Lot, serial or model codes
- Lot 1599211, Expiry Date: 18SEP2015 (12 days after calibration)
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- NAW
- Firm FEI
- 3002124543
- Firm city
- Farnham
- Firm state
- not on file
- Firm country
- United Kingdom
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