RegWardenFDA facility compliance records
Company

CANON INC.

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

Recalls by year

FDA actions on record by year2010: 1 recalls; 2012: 1 recalls1’10’111’12’13’14’15’16’17’18’19’20’21’22’23’24’25’26
  • Recalls (2)

Registered facilities (5)

Recalls & enforcement

  • Class IITerminated2012-12-05
    Canon Inc. had received 17 claims from our foreign sales companies between October to November 2012 that measurement value of RK-F2s refractive power (SPH value) sometimes indicated abnormal value which occurs approximately 5% in probability.
  • Class IITerminated2010-11-01
    Screws holding the 55REF circuit board are loosening and roaming inside of the sealed sensor.

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. “CANON INC. — 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-8030410-canon-inc/

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