RegWardenFDA facility compliance records
Facility

STINGRAY SURGICAL PRODUCTS

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

Activity by year

FDA actions on record by year2012: 1 recalls; 2016: 1 inspections; 2019: 1 inspections; 2023: 1 inspections; 2024: 1 inspections1’12’13’14’151’16’17’181’19’20’21’221’231’24’25’26
  • Recalls (1)
  • Inspections (4)

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 IITerminated2012-05-23
    On 05/23/2012, Stingray Surgical Products, LLC., Boca Raton, FL initiated a recall initiated due to "Instructions For Use" of Bipolar Forceps not being cleared by FDA and incorrect "Instructions For Use" . The sterilization instructions have been altered without the clearance of…

FDA inspections (4)

  • NAI2024-12-11
    No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices
  • NAI2023-02-09
    No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
  • NAI2019-12-20
    No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
  • VAI2016-11-22
    Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted

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. “STINGRAY SURGICAL PRODUCTS (FEI 3006059917) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3006059917-stingray-surgical-products/

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