Galt Medical Corporation: Device Recall
Recall #Z-1734-2025 · 03/27/2025
Class II: Risk
Recall Details
- Recall Number
- Z-1734-2025
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Galt Medical Corporation
- Status
- Ongoing
- Date Initiated
- 03/27/2025
- Location
- Garland, TX, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 100 guidewires
Reason for Recall
Due to a potential open seal in the sterile barrier packaging.
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.
Distribution Pattern
Worldwide - U.S. Nationwide distribution in the states of AL, FL, GA, IL, MA, OH, PA, and UT. The countries of Canada, Ireland, Israel, Korea, Qatar, and United Kingdom.
Other Recalls by Galt Medical Corporation
- Class II: Risk 03/27/2025
- Class II: Risk 03/27/2025
- Class II: Risk 03/27/2025
- Class II: Risk 03/27/2025
- Class II: Risk 03/27/2025
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.