FDA DevicesClass II
Tangent Endoscopy, Tangent Single Use Digital Catheter. Model Numbers: (1) T...
Published: May 27, 2026Recall ID: Z-2209-2026Category: devicesCountry: US
Reason for Recall / Hazard
Affected devices exhibited fractures at the distal shaft tip without complete detachment.
Product Description & Identification
Tangent Endoscopy, Tangent Single Use Digital Catheter. Model Numbers: (1) TNG4002-IND. (2) TNG-4007-6pk.
Affected Products
Tangent Endoscopy, Tangent Single Use Digital Catheter. Model Numbers: (1) TNG4002-IND. (2) TNG-4007-6pk.
Additional Source Details
| Field | Value |
|---|---|
| City | Camden |
| State | DE |
| Event id | 98654 |
| Address 1 | 2140 S Dupont Hwy |
| Code 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 |
| Postal code | 19934-1249 |
| Report date | 20260527 |
| Product type | Devices |
| Product quantity | 53 units |
| Reason for recall | Affected devices exhibited fractures at the distal shaft tip without complete detachment. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260323 |
| Initial firm notification | |
| Center classification date | 20260515 |
Overview
- Recalling FirmTANGENT ENDOSCOPY, LLC
- StatusOngoing
- Risk LevelClass II
- DistributionUS Nationwide distribution in the states of North Carolina, Arizona, and Nevada.