CLASS II Device recall · Reported 19 Oct 2016 · FDA Enforcement Report
TheraSphere(R) Yttrium-90 Class Microsphere Injection recalled
Biocompatibles U.K is recalling TheraSphere(R) Yttrium-90 Class Microsphere Injection TheraSphere¿ is indicated for, distributed in 17 states. The recall was initiated on 21 Sep 2015 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0078-2017
- FDA event ID
- 75350
- Recalling firm
- Biocompatibles U.K, Farnham, N/A
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 21 Sep 2015
- FDA classified
- 13 Oct 2016
- Reported
- 19 Oct 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Labeling Errors
- Device type
- Heart & Vascular Devices
Timeline
| 21 Sep 2015 | Recall initiated by company | |
| 13 Oct 2016 | Classified by FDA | +388 days |
| 19 Oct 2016 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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.
Where it was distributed
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
CaliforniaFloridaIllinoisIndianaKentuckyMassachusettsMarylandMichiganMinnesotaNevadaNew YorkOhioOregonPennsylvaniaTexasWashingtonWisconsin
Questions about this recall
Why was it 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.
Which lots are affected?
Lot 1599211, Expiry Date: 18SEP2015 (12 days after calibration)
Where was it sold?
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
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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