FDA Medical devices recall ·
Introducer Needle recall
- Recall number
- Z-1736-2025
- 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
- 200 needles
- Hazard tags
- Sterility
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Introducer Needle REF NDL-107-04 These needles are used for the percutaneous introduction of guidewires
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: NDL-107-04 UDI-DI code: 00841268102729 Lot Number: 24108670
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-1736-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.