HIGH

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.

Quick Facts at a Glance

Recall Date
March 23, 2026
Hazard Level
HIGH
Brand
TANGENT ENDOSCOPY
Geographic Scope
1 states

Hazard Information

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

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact TANGENT ENDOSCOPY, LLC or your healthcare provider for instructions. Notification method: E-Mail

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Full Description

Tangent Endoscopy, Tangent Single Use Digital Catheter. Model Numbers: (1) TNG4002-IND. (2) TNG-4007-6pk.. Reason: Affected devices exhibited fractures at the distal shaft tip without complete detachment.. Classification: Class II. Quantity: 53 units. Distribution: US Nationwide distribution in the states of North Carolina, Arizona, and Nevada.

Safety Guide

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Product Classification

Product Details

Model Numbers
(1) Model Number: TNG4002-IND
UDI-DI: (1) 00850061601001
Lot numbers: 2510900
2512938
and 2601944. (2) Model Number: TNG-4007-6pk
+2 more
Affected States
ALL
Report Date
May 27, 2026
Recall Status
ACTIVE