Class II — STERILMED, INC.
| Recalling firm | STERILMED, INC. |
|---|---|
| Registered facility | STERILMED, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 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 |
| Product | Biosense Webster's Reprocessed SOUNDSTAR® eco Diagnostic Ultrasound Catheters, Catalog Nos: M-5723-115, Model Number BIO10438577. |
| Quantity | 22 |
| Distribution | US Distribution including the states of WA and CA. |
| Initiated | 2014-09-24 |
| Classified | 2014-10-09 |
| Terminated | 2015-08-11 |
| Recall number | Z-0059-2015 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — STERILMED, INC. (Z-0059-2015).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/69337/
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