RegWardenFDA facility compliance records
Company

DKK DAI-ICHI SHOMEI CO, LTD

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

Recalls by year

FDA actions on record by year2023: 1 recalls; 2024: 1 recalls201720182019202020212022120231202420252026
  • Recalls (2)

Registered facilities (1)

Recalls & enforcement

  • Class IIOngoing2024-07-09
    The weld on the light head frame can crack which could lead to problems such as the light head frame sagging, the plastic front face housing cracking, or the light head detaching.
  • Class IIOngoing2023-08-23
    The stopper block on the LFS bracket could be broken or missing. Without this stopper block, the flat screen attached to the LFS flat screen system can rotate beyond the original angle limit and it could cause excessive force to be given to the spring shaft of the LFS bracket. Du…

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. “DKK DAI-ICHI SHOMEI CO, LTD — 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-9042505-dkk-dai-ichi-shomei-co-ltd/

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