RegWardenFDA facility compliance records
Facility

Sutter Medical Technologies USA Inc.

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

Activity by year

FDA actions on record by year2020: 1 recalls20172018201912020202120222023202420252026
  • Recalls (1)

Devices registered here (1)

  • Electrosurgical, Cutting & Coagulation & Accessories
    Product code GEI (opens in a new tab) · Class II · General, Plastic Surgery · 21 CFR 878.4400

Recalls & enforcement

  • Class IITerminated2020-06-23
    The label on the cardbox and the blister show the correct symbols for sterilization using irradiation and storage at 5 C to 40 C, the package insert (IFU) is labelled incorrectly. It shows the symbol for sterilization using Ethylene Oxide with the description for sterilization us…

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. “Sutter Medical Technologies USA Inc. (FEI 3012940012) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3012940012-sutter-medical-technologies-usa-inc/

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