Stryker Sustainability Solutions: Medical Device Recall in 2016 - (Recall #: Z-0380-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

Reprocessed Daig Steerable and Daig Supreme Fixed Curve Diagnostic Electrophysiology Catheters Model Numbers: 401940, 402004 UPC Code: 00885825007409 00885825007744 Diagnostic electrophysiology (EP) catheters are specially designed electrode catheters that transmit electrical impulses and can be positioned for endocardial recording or stimulation. Diagnostic EP catheters incorporate a handpiece, a flexible shaft and a distal tip section containing diagnostic electrodes. Reprocessed Diagnostic EP Catheters are indicated for temporary intracardiac sensing, recording, stimulation, and electrophysiology mapping of cardiac structures.

Product Classification:

Class II

Date Initiated: October 6, 2016

Date Posted: November 16, 2016

Recall Number: Z-0380-2017

Event ID: 75409

Reason for Recall:

The EP Catheters may be mislabeled for French size during reprocessing.

Status: Terminated

Product Quantity: 4 devices

Code Information:

Item Number Serial Number Manufacturing Date 401940 1902898 3/31/2015 401940 1908621 3/31/2015 402004 1902392 1/9/2015 402004 1902389 1/9/2015

Distribution Pattern:

U.S. distribution to the following; AZ, MN and MO.

Voluntary or Mandated:

Voluntary: Firm initiated