RegWardenFDA facility compliance records
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
ReasonThere is a potential for separation at the male connector.
ProductCordis Angiographic Catheter Extensions. Used to transport fluid from the power injector to the catheter for injection into the patient.
Quantity16,950 units (2,915 US and 14,000 OUS)
DistributionNationwide distribution to AZ, CA, DC, FL, GA, KY, LA, MD, MS, NY, OH, TX, WV, WY and PR. International distribution to Japan, Korea, Republic of, United Arab Emirates, Austria, Belgium, Czech Republic, Germany, Spain, France, United Kingdom, Iceland, Ireland, Israel, Netherlands, Portugal, Russia.
Initiated2022-11-07
Classified2022-12-15
Recall numberZ-0720-2023
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-0720-2023).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/91138/

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