Recall Z-2209-2026 ยท FBN Choledochoscope And Accessories, Flexible/Rigid
TANGENT ENDOSCOPY, LLC
Tangent Endoscopy, Tangent Single Use Digital Catheter. Model Numbers: (1) TNG4002-IND. (2) TNG-4007-6pk.
| Date | May 15, 2026 (initiated Mar 23, 2026) |
| Status | Open, Classified |
| Reason | Affected devices exhibited fractures at the distal shaft tip without complete detachment. |
| Root cause | Process control |
| Action | On March 23, 2026, URGENT: MEDICAL DEVICE RECALL letters were sent to customers. Actions to be taken: Tangent requests that you discontinue use of and return all products from the lot number referenced above. We will ship you new devices and will notify you on ship date. Our records indicate that you have purchased one or more of products from these lots. Please acknowledge the email with a confirmation including the devices on hand. To find the lot number, please check the label on the package which clearly states this information. Instructions to return inventory: Please ship devices via F |
| Quantity | 53 units |
| Distribution | US Nationwide distribution in the states of North Carolina, Arizona, and Nevada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K251170 | Tangent Single-Use Digital System: Tangent Single-Use Digital Catheter and Tangent Digital Controller Tangent Endoscopy, LLC, Sep 12, 2025 |