FDA Medical devices recall ·
GALT Guidewire recall
- Recall number
- Z-1734-2025
- Date
- (initiated March 27, 2025)
- Company / brand
- Galt Medical Corporation
2220 Merritt Dr, Garland, TX, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 100 guidewires
- Hazard tags
- Sterility
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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.
Why was it recalled?
Due to a potential open seal in the sterile barrier packaging.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Catalog Number: SGW-051-07 UDI-DI code: 0084126810132 Lot Number: 25050797
Distribution
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.
States: Alabama Florida Georgia Illinois Massachusetts Ohio Pennsylvania Utah
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1734-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.