Sirtex SIR-yttrium 90 microspheres — Class III medical device recall Z-1162-2013
Terminated recall by Sirtex Medical Limited, reported 2013-05-01, distributed nationwide. Incorrect expiration date
| Recall number | Z-1162-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Sirtex Medical Limited, North Ryde, New South Wales, Australia |
| Recall initiated | 2013-02-27 |
| Classified | 2013-04-23 |
| Reported by FDA | 2013-05-01 |
| Terminated | 2015-03-30 |
| Distributed | Nationwide (US) |
| Quantity | 21 doses |
| Reason classes | labeling |
| Lot numbers | HB024V02, HB024V10, HB024V14, HB025V02 |
Product
Sirtex SIR-yttrium 90 microspheres (Radionuclide); SIR-Y001. Indicated for the treatment of unresectable metastatic liver tumors.
Reason for recall
Incorrect expiration date
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-1162-2013. 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.