FDAHealthMarch 23, 2026

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

⚠️ Affected devices exhibited fractures at the distal shaft tip without complete detachment.

Is this relevant to me?

Geography: Nationwide
Source agency: FDA
Category: Health
Published: March 23, 2026

US Nationwide distribution in the states of North Carolina, Arizona, and Nevada.

What's affected?

Product: Tangent Endoscopy, Tangent Single Use Digital Catheter. Model Numbers: (1) TNG4002-IND. (2) TNG-4007-6pk.
Brand: TANGENT ENDOSCOPY, LLC
Lot code: 2510900

Additional details

(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

What should I do?

Recommended action

Class II recall. Voluntary: Firm initiated Quantity affected: 53 units.

View original FDA notice →

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