Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Electrophysiology catheter cables are designed as electrode cables with a Recalled by Sterilmed Inc Due to Sterilmed is recalling all lots of specific product...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Sterilmed Inc directly.
Affected Products
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
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed to 17 states: AL, AR, CO, FL, IL, MI, MS, MO, MT, NC, OH, PA, TN, TX, VA, WV, WI
About Sterilmed Inc
Sterilmed Inc has 2 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report