Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
TheraSphere(R) YTTRIUM-90 CLASS MICROSPHERE INJECTION TheraSphere¿ is indicated for radiation Recalled by Biocompatibles U.K., Ltd. Due to Mislabeling
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Biocompatibles U.K., Ltd. directly.
Affected Products
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.
Quantity: 64 doses
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed to 17 states: CA, FL, IL, IN, KY, MD, MA, MI, MN, NV, NY, OH, OR, PA, TX, WA, WI
About Biocompatibles U.K., Ltd.
Biocompatibles U.K., Ltd. has 2 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report