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TANGENT ENDOSCOPY, LLC: Tangent Endoscopy, Tangent Single Use Digital Catheter. Model Numbers: (1) TNG4002-IND. (2) TNG-4007-6pk.

Medical DevicesSource: FDA (device) · Date: 2026-05-27

Read the official notice at FDA (device) →

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
TANGENT ENDOSCOPY, LLC
Product
Tangent Endoscopy, Tangent Single Use Digital Catheter. Model Numbers: (1) TNG4002-IND. (2) TNG-4007-6pk.
Reason / hazard
Affected devices exhibited fractures at the distal shaft tip without complete detachment.
Classification
Class II
Status
Ongoing
Distribution / sold at
US Nationwide distribution in the states of North Carolina, Arizona, and Nevada.
Recall initiated
2026-03-23
Code info
(1) Model Number: TNG4002-IND; UDI-DI: (1) 00850061601001; Lot numbers: 2510900, 2512938, and 2601944. (2) Model Number: TNG-4007-6pk; UDI-DI: 00850061601001; Lot numbers: 2510900, 2512938, and 2601944
Product quantity
53 units
Voluntary mandated
Voluntary: Firm initiated
City
Camden
State
DE
Country
United States
Event id
98654
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