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Recall

Class II — Cordis Corporation

Recalling firmCordis US Corp.
Registered facilityView this company's 2 registered facilities → (openFDA recall records do not name a specific facility)
ClassificationClass II
StatusTerminated
ReasonProduct was manufactured utilizing an expired inner body.
ProductCordis MAXI LD PTA Dilatation Catheter, for cardiovascular use.
Quantity21 units
DistributionUS distribution to AL, AZ, FL, MN, and MO
Initiated2019-10-04
Classified2019-10-30
Terminated2020-12-14
Recall numberZ-0250-2020
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 Corporation (Z-0250-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/83977/

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