Medical device recalls Moderate risk

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

Recall date
March 23, 2026
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2209-2026
FDA classification
Class II
Brand / firm
TANGENT ENDOSCOPY, LLC
Sold / distributed
US Nationwide distribution in the states of North Carolina, Arizona, and Nevada.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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