FDA recall Z-2209-2026

TANGENT ENDOSCOPY, LLC · Class II · device

Product

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.

Distribution

US Nationwide distribution in the states of North Carolina, Arizona, and Nevada.

Key facts

Status
Ongoing
Initiation date
2026-03-23
Report date
2026-05-27
Voluntary/Mandated
Voluntary: Firm initiated
Location
Camden, DE, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2209-2026