Z-2209-2026 Class II Ongoing
FDA device recall Z-2209-2026 was initiated by TANGENT ENDOSCOPY, LLC on March 23, 2026 and is designated Class II. Reason for recall: Affected devices exhibited fractures at the distal shaft tip without complete detachment. The recall status is ongoing. Affected quantity: 53 units.
Recall Details
- Product Type
- Devices
- Report Date
- May 27, 2026
- Initiation Date
- March 23, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 53 units
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.
Distribution Pattern
US Nationwide distribution in the states of North Carolina, Arizona, and Nevada.
Code Information
(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