Recall Z-2209-2026— TANGENT ENDOSCOPY, LLC

Name: FDA recall Z-2209-2026
Creator: U.S. Food and Drug Administration
Published: 2026-03-23

Class II · Ongoing

Class II FDA medical device recall by TANGENT ENDOSCOPY, LLC, initiated 2026-03-23. It names one FDA 510(k) clearance: K251170. Product: 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..

Recalling firm: TANGENT ENDOSCOPY, LLC
Classification: Class II
Status: Ongoing
Initiated: 2026-03-23
Firm location: Camden, DE, United States

510(k) clearances named in this recall

1 on FDA's record

K251170 — Tangent Single-Use Digital System: Tangent Single-Use Digital Catheter and Tangent Digital ControllerTangent Endoscopy, LLC·cleared 2025-09-12

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.