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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
ReasonCordis is recalling one (1) lot of POWERFLEX P3 PTA Dilatation Catheter due to the potential for body/shaft voids in the proximal seal area.
ProductCordis POWERFLEX P3, PTA Dilation Catheter, REF 420-6020S
Quantity89 units
DistributionUS and UK
Initiated2020-01-08
Classified2020-03-12
Terminated2023-01-13
Recall numberZ-1477-2020
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-1477-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/84680/

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