Official recall notice
FDA DeviceClass IINotable
Tangent Endoscopy Recall (May 2026)
Product: Tangent Endoscopy, Tangent Single Use Digital Catheter. Model Numbers: (1) TNG4002-IND. (2) TNG-4007-6pk.
- Recall date
- 2026-05-27
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
Hazard
Affected devices exhibited fractures at the distal shaft tip without complete detachment.
Product description
Affected devices exhibited fractures at the distal shaft tip without complete detachment.