Sterilmed Inc: Medical Device Recall in 2017 - (Recall #: Z-2669-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: May 8, 2017

Date Posted: July 12, 2017

Recall Number: Z-2669-2017

Event ID: 77190

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.

Status: Terminated

Product Quantity: 963 devices

Code Information:

all lots

Distribution Pattern:

US Distribution to the states of : AL, AR, CO, FL, IL, MI, MO, MS, MT, NC, OH, PA, TN, TX, VA WI and WV.

Voluntary or Mandated:

Voluntary: Firm initiated