Facility

GULF FIBEROPTICS, INC.

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

Key facts

1recalls · worst Class II

2inspections · worst VAI

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3003768921
Establishment type	Manufacture Medical Device
Location	448 Commerce Blvd OLDSMAR, FL, US 34677
Registration status	Active · expires 2026
Parent company	GULF FIBEROPTICS, INC (owner-operator 9051646)
Brand names	Gulf Fiberoptics Rigid Endoscope Fiber Optic Light Cord; Rigid Endoscope Fiber Optic Light Cord

Activity by year

Recalls (1)
Inspections (2)

Devices registered here (2)

Illuminator, Fiberoptic, Surgical Field
Product code HBI (opens in a new tab) · Class II · General, Plastic Surgery · 21 CFR 878.4580
Image, Illumination, Fiberoptic, For Endoscope
Product code FFS (opens in a new tab) · Class II · Gastroenterology, Urology · 21 CFR 876.1500

Recalls & enforcement

Class IITerminated2012-04-09
The GMF-RC65 Replacement Surgical Headlight Cable for Cogent Microlink falls outside of the firm's 510k due to light transmitting fiber material difference.

FDA inspections (2)

NAI2023-03-23
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices
VAI2019-12-18
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.

All facilities operated by GULF FIBEROPTICS, INC

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. “GULF FIBEROPTICS, INC. (FEI 3003768921) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3003768921-gulf-fiberoptics-inc/

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