Official recall notice

FDA DeviceClass IINotable

FDA Recall: Tangent Endoscopy, Tangent Single Use Digital Catheter. Model Numbers: (1) TNG4002-IND. (2) TN

Recall date
2026-05-27
FDA class
Class II

Why it was recalled

Hazard

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

Recommended action

What to do

53 units

Product description

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

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