TheraSphere — Class II medical device recall Z-0078-2017
Terminated recall by Biocompatibles U.K., Ltd., reported 2016-10-19, distributed in CA, FL, IL, IN, KY, MA, MD, MI…. One mislabeled dose of TheraSphere¿ Y-90 Glass Microspheres, which was shipped to Hong Kong (total radioactivi
| Recall number | Z-0078-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Biocompatibles U.K., Ltd., Farnham, N/A, United Kingdom |
| Recall initiated | 2015-09-21 |
| Classified | 2016-10-13 |
| Reported by FDA | 2016-10-19 |
| Terminated | 2016-10-17 |
| Distributed | CA, FL, IL, IN, KY, MA, MD, MI, MN, NV, NY, OH, OR, PA, TX, WA, WI |
| Countries outside the US | DE, HK, IT, PT, TR |
| Quantity | 64 doses |
| Reason classes | foreign material, labeling |
| Lot numbers | 1599211 |
| Expiration dates | 2015-09-18 |
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.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0078-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.