Biosense Webster's Reprocessed SOUNDSTAR¿ eco Diagnostic Ultrasound… — Class II medical device recall Z-0059-2015
Terminated recall by STERILMED, INC., reported 2014-10-15, distributed in CA, WA. Sterilmed, a division of Johnson & Johnson Medical NV/SA (Sterilmed), has become aware of an issue affecti
| Recall number | Z-0059-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | STERILMED, INC., Maple Grove, MN, United States |
| Recall initiated | 2014-09-24 |
| Classified | 2014-10-09 |
| Reported by FDA | 2014-10-15 |
| Terminated | 2015-08-11 |
| Distributed | CA, WA |
| Quantity | 22 |
| Lot numbers | 1717945, 1721574, 1721575, 1723123 |
| Model numbers | BIO10438577, M-5723-115 |
Product
Biosense Webster's Reprocessed SOUNDSTAR¿ eco Diagnostic Ultrasound Catheters, Catalog Nos: M-5723-115, Model Number BIO10438577.
Reason for recall
Sterilmed, a division of Johnson & Johnson Medical NV/SA (Sterilmed), has become aware of an issue affecting certain lots of Reprocessed SOUNDSTAR® eco Diagnostic Ultrasound Catheters for which Sterilmed is the reprocessor and Biosense Webster is the distributor. Sterilmed determined that the units of these lots were incorrectly processed and as a result when the affected catheter is conne
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-0059-2015. 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.