FDAFDA · Food and drugs·Recall number Z-1734-2025
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.
Published May 14, 2025 · Recall initiated: March 27, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Due to a potential open seal in the sterile barrier packaging.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Galt Medical Corporation
- Distributor
- 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.
- Lot
- Catalog Number: SGW-051-07 UDI-DI code: 0084126810132 Lot Number: 25050797
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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