Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Reprocessed Daig Steerable and Daig Supreme Fixed Curve Diagnostic Electrophysiology Recalled by Stryker Sustainability Solutions Due to Mislabeling

Date: October 6, 2016
Company: Stryker Sustainability Solutions
Status: Terminated
Source: FDA (Device)

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 Stryker Sustainability Solutions directly.

Affected Products

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.

Quantity: 4 devices

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed to 3 states: AZ, MN, MO

Affected (3 states)Not affected

About Stryker Sustainability Solutions

Stryker Sustainability Solutions has 38 total recalls tracked by RecallDetector.

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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report