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Recall

Class II — Cordis US Corp

Recalling firmCordis US Corp.
Registered facilityView this company's 2 registered facilities → (openFDA recall records do not name a specific facility)
ClassificationClass II
StatusOngoing
ReasonCatheter manufactured at the incorrect length.
ProductVista 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.
Quantity12 units
DistributionUS: WA OUS: Japan
Initiated2025-02-07
Classified2025-03-13
Recall numberZ-1330-2025
InitiationVoluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class II recall — Cordis US Corp (Z-1330-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/96272/

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