FDA Device recall Z-2209-2026
Tangent Endoscopy, Tangent Single Use Digital Catheter
- FDA Device
- Class II
- ongoing
- Published 2026-05-27
On 2026-05-27 the FDA classified a Class II recall of Tangent Endoscopy, Tangent Single Use Digital Catheter by Tangent Endoscopy, citing affected devices exhibited fractures at the distal shaft tip without complete detachment.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2209-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-03-23 |
| Published | 2026-05-27 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Tangent Endoscopy |
| Distribution | US |
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.
Identifiers
| code_info | (1) Model Number: TNG4002-IND; UDI-DI: (1) 00850061601001; Lot numbers: 2510900, 2512938, and 2601944. (2) Model Numbe…(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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2209-2026%22
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