Tangent Endoscopy recall (TANGENT ENDOSCOPY, LLC)
Medical deviceClass IIOngoing
Summary: TANGENT ENDOSCOPY, LLC is recalling 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.
What is being recalled
Tangent Endoscopy, Tangent Single Use Digital Catheter. Model Numbers: (1) TNG4002-IND. (2) TNG-4007-6pk.
Why
Affected devices exhibited fractures at the distal shaft tip without complete detachment.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
US Nationwide distribution in the states of North Carolina, Arizona, and Nevada. (states named: Arizona, North Carolina, Nevada)
How to tell if yours is affected
(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
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-2209-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | March 23, 2026 |
| Reported | May 27, 2026 |
| Company | TANGENT ENDOSCOPY, LLC |
| Company location | Camden, DE, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 53 units |
More recalls from TANGENT ENDOSCOPY, LLC · all medical device recalls · recalls from March 2026