Electrophysiology catheter cables are designed as electrode cables… — Class II medical device recall Z-2669-2017
Terminated recall by Sterilmed Inc, reported 2017-07-12, distributed in AL, AR, CO, FL, IL, MI, MO, MS…. Sterilmed is recalling all lots of specific product codes of unexpired Sterilmed Reprocessed EP Ablation Cable
| Recall number | Z-2669-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Sterilmed Inc, Minneapolis, MN, United States |
| Recall initiated | 2017-05-08 |
| Classified | 2017-07-03 |
| Reported by FDA | 2017-07-12 |
| Terminated | 2018-05-22 |
| Distributed | AL, AR, CO, FL, IL, MI, MO, MS, MT, NC, OH, PA, TN, TX, VA, WI, WV |
| Quantity | 963 devices |
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.
Reason for recall
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.
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-2669-2017. 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.