Recall Z-1734-2025— Galt Medical Corporation

Name: FDA recall Z-1734-2025
Creator: U.S. Food and Drug Administration
Published: 2025-03-27

Class II · Ongoing

Class II FDA medical device recall by Galt Medical Corporation, initiated 2025-03-27. It names one FDA 510(k) clearance: K982559. Product: GALT Guidewire REF SGW-051-07 Guidewires are intended for use in percutaneous procedures, to introduce and position catheters and other interventional devices within the Coronary and peripheral vasculature.. Reason: Due to a potential open seal in the sterile barrier packaging..

Recalling firm: Galt Medical Corporation
Classification: Class II
Status: Ongoing
Initiated: 2025-03-27
Firm location: Garland, TX, United States

510(k) clearances named in this recall

1 on FDA's record

K982559 — GUIDEWIREGalt Medical Corp.·cleared 1999-02-01

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

GALT Guidewire REF SGW-051-07 Guidewires are intended for use in percutaneous procedures, to introduce and position catheters and other interventional devices within the Coronary and peripheral vasculature.

Reason for recall

Due to a potential open seal in the sterile barrier packaging.

Data sourced from openFDA. This site is unofficial and independent of the FDA.