RecallRadar

FDA Device recall Z-1330-2025

Vista Brite Tip, Judkins Right 4, REF SM7504, JR3 VBT (Special) 110 cm 6F. Guiding catheter is intended for use for intravascular introduct…

On 2025-03-19 the FDA classified a Class II recall of Vista Brite Tip, Judkins Right 4, REF SM7504, JR3 VBT (Special) 110 cm 6F. Guiding catheter is intended for use for intravascular introduct… by Cordis Us, citing catheter manufactured at the incorrect length.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1330-2025
ClassificationClass II
Statusongoing
Initiated2025-02-07
Published2025-03-19
Last updated2026-09-13 11:57 UTC
CompanyCordis Us
DistributionWA

Product

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.

Reason

Catheter manufactured at the incorrect length.

Identifiers

code_infoUDI: 20705032042991/ Lot Number: 18368326

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1330-2025%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.