Class 2 Device Recall Tangent Single Use Digital Catheter

• Date Initiated by Firm: March 23, 2026
• Date Posted: May 15, 2026
• Recall Status: Open, Classified
• Recall Number: Z-2209-2026
• Recall Event ID: 98654
• 510(K)Number: K251170
• Product Classification: Choledochoscope and accessories, flexible/rigid - Product Code FBN
• Product: Tangent Endoscopy, Tangent Single Use Digital Catheter. Model Numbers: (1) TNG4002-IND. (2) TNG-4007-6pk.
• 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
• FEI Number: 3041659934
• Recalling Firm/ Manufacturer: TANGENT ENDOSCOPY, LLC; 2140 S Dupont Hwy; Camden DE 19934-1249
• For Additional Information Contact: Daniel Amendola; 707-480-2297
• Manufacturer Reason for Recall: Affected devices exhibited fractures at the distal shaft tip without complete detachment.
• FDA Determined 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 Fedex overnight delivery, using Account 902012001. Devices must be shipped to the following address: TAG3 Engineering - Attention Scott Arp 1161 Sawgrass Corporate Parkway Sunrise, FL 33323, USA 4932-9431-8931 2 If you have any questions, please contact Shanita Shafeek at (305) 409-4946 or email Shanita@avire-med.com
• Quantity in Commerce: 53 units
• Distribution: US Nationwide distribution in the states of North Carolina, Arizona, and Nevada.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = FBN