Facility

TANGENT ENDOSCOPY, LLC

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

Key facts

1recalls · worst Class II

—inspections in our data

—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)	3041659934
Establishment type	Develop Specifications But Do Not Manufacture At This Facility
Location	2140 S Dupont Hwy Camden, DE, US 19934
Registration status	Active · expires 2026
Parent company	Tangent Endoscopy, LLC (owner-operator 10094122)
Brand names	Tangent Digital Catheter; Tangent Digital Catheter System; Tangent Digital Controller

Activity by year

Recalls (1)

Devices registered here (3)

Endoscopic Video Imaging System/Component, Gastroenterology-Urology
Product code FET (opens in a new tab) · Class II · Gastroenterology, Urology · 21 CFR 876.1500
Choledochoscope And Accessories, Flexible/Rigid
Product code FBN (opens in a new tab) · Class II · Gastroenterology, Urology · 21 CFR 876.1500
Led Light Source
Product code NTN (opens in a new tab) · Class II · Gastroenterology, Urology · 21 CFR 876.1500

Recalls & enforcement

Class IIOngoing2026-03-23
Affected devices exhibited fractures at the distal shaft tip without complete detachment.

All facilities operated by Tangent Endoscopy, LLC

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. “TANGENT ENDOSCOPY, LLC (FEI 3041659934) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3041659934-tangent-endoscopy-llc/

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