Class II — Oscor, Inc.
| Recalling firm | OSCOR INC. |
|---|---|
| Registered facility | OSCOR INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Oscor, Inc. in Palm Harbor, FL is recalling myocardial heart wires, models TME60S, TME64S, TME64C, TME64S-3, TME65S, and TME66S. The recall was initiated due to the spacing between anchoring zig-zag to electrode is out of specification. |
| Product | Myocardial Heart Wires Intended for temporary atrial and ventricular pacing and sensing during or after cardiac surgery in conjunction with an external pulse generator. |
| Quantity | 1425 |
| Distribution | Worldwide Distribution - USA including OR, FL, Al, TX, NM, CA, AL, PA, KY, IN, OH, and IL and internationally to Canada, Russia, and New Zealand |
| Initiated | 2012-07-25 |
| Classified | 2012-10-29 |
| Terminated | 2013-12-17 |
| Recall number | Z-0165-2013 |
| 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 — Oscor, Inc. (Z-0165-2013).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/63112/
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