Recalling firm
TANGENT ENDOSCOPY, LLC
Product type
Device
Status
Ongoing
Report date
2026-05-27
Distribution
US Nationwide distribution in the states of North Carolina, Arizona, and Nevada.
Firm state
DE
Product quantity
53 units
Initiated by
Voluntary: Firm initiated
Reason for recall
Affected devices exhibited fractures at the distal shaft tip without complete detachment.
Product description
Tangent Endoscopy, Tangent Single Use Digital Catheter. Model Numbers: (1) TNG4002-IND. (2) TNG-4007-6pk.
Code / lot info
(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
Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.