Class II

Medical Device Recall: Introducer Needle REF NDL-107-04 These needles are used for the percutaneous introduction of guidewires

Galt Medical Corporation · March 27, 2025

Reason for Recall

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

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 Affected

NATIONWIDE

Quantity Affected

200 needles

Source: FDA (openFDA Device Enforcement)

Recall number: Z-1736-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

Galt Medical Corporation Medical Device Recall: Introducer Needle REF NDL-107-04 These needles are used for the percutaneous introduction of guidewires | SafeCheck