Medical device recalls Moderate risk

Cordis US Corp recalls Vista Brite Tip, Judkins Right 4, REF SM7504, JR3 VBT (Special) 110 cm 6F. Guiding catheter is intended for use for int…

Recall date
February 7, 2025
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1330-2025
FDA classification
Class II
Brand / firm
Cordis US Corp
Sold / distributed
US: WA OUS: Japan

Why it was recalled

Catheter manufactured at the incorrect length.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Vista Brite Tip, Judkins Right 4, REF SM7504, JR3 VBT (Special) 110 cm 6F. Guiding catheter is intended for use for intravascular introduction of interventional/diagnostic devices into the coronary or peripheral vascular systems.

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