The FDA has posted 8 enforcement recalls from Galt Medical Corporation since 2025, none of them Class I (most serious). Most recent report: Aug 19, 2026.
Black depth markings may detach from the outer sheath of the coaxial dilator introducer component of transcarotid-peripheral access kits.
Due to a potential open seal in the sterile barrier packaging.
Due to a potential open seal in the sterile barrier packaging .
Due to a potential open seal in the sterile barrier packaging .
Due to a potential open seal in the sterile barrier packaging.
Due to a potential open seal in the sterile barrier packaging.
Due to a potential open seal in the sterile barrier packaging.
Due to a potential open seal in the sterile barrier packaging .
Firm name as filed with the FDA: “Galt Medical Corporation”. Related firm entities may file under separate names. Source: U.S. FDA openFDA device enforcement reports. Informational only — verify with the FDA before acting.