RegWardenFDA facility compliance records
Company

CODAN US Corporation

2 recall(s) on record — most severe on record: Class II.

Recalls by year

FDA actions on record by year2011: 1 recalls; 2019: 1 recalls1’11’12’13’14’15’16’17’181’19’20’21’22’23’24’25’26
  • Recalls (2)

Registered facilities (3)

Recalls & enforcement

  • Class IITerminated2019-09-12
    Individual packages of connectors may have incomplete or bad seals which would compromise sterility.
  • Class IITerminated2011-08-17
    CODAN US Corporation is recalling the ColorSafe IV (intravenous) product lines because they were manufactured and marketed prior to FDA approval.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.

Cite this record

RegWarden. “CODAN US Corporation — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-8010060-codan-us-corporation/

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