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 is recalling all lots of specific product codes of unexpired Sterilmed Reprocessed EP Ablation Cables because Sterilmed determined that the cables are Class III devices and thus require, but do not currently have, premarket review and approval. |
| Product | Electrophysiology catheter cables are designed as electrode cables with a multi-pin connector on the distal end and the appropriate number of tails on the proximal end. The cables serve two different purposes. They either serve as an extension between an EP catheter and equipment out of reach or they interface an EP catheter with the appropriate external stimulation of recording equipment. |
| Quantity | 963 devices |
| Distribution | US Distribution to the states of : AL, AR, CO, FL, IL, MI, MO, MS, MT, NC, OH, PA, TN, TX, VA WI and WV. |
| Initiated | 2017-05-08 |
| Classified | 2017-07-03 |
| Terminated | 2018-05-22 |
| Recall number | Z-2669-2017 |
| 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-2669-2017).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/77190/
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