RegWardenFDA facility compliance records
Facility

MIZUHO AMERICA, INC.

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

Activity by year

FDA actions on record by year2013: 1 recalls; 2019: 1 recalls, 1 inspections1’13’14’15’16’17’182’19’20’21’22’23’24’25’26
  • Recalls (2)
  • Inspections (1)

Devices registered here (1)

  • Dissector, Surgical, General & Plastic Surgery
    Product code GDI (opens in a new tab) · Class I · General, Plastic Surgery · 21 CFR 878.4800

Recalls & enforcement

  • Class IIOngoing2019-09-11
    Unintended tilting of the Tabletop MST 7300BX and incorrect operation due to infrared operating signal errors of Tabletops MST 7300B and MST 7300BX.
  • Class IITerminated2013-10-10
    Specific item numbers form Lots 27-J and 29-J of Sugita T2 Aneurysm Clips. Mini Temporary Type, are discolored.

FDA inspections (1)

  • NAI2019-12-17
    No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

Related

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “MIZUHO AMERICA, INC. (FEI 1000159388) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/1000159388-mizuho-america-inc/

Not open yet

Alerts for MIZUHO AMERICA, INC.

Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.

Planned

Want a one-page facility brief?

A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.