Recall Z-2209-2026
Tangent Endoscopy, LLC · initiated March 23, 2026
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Tangent Endoscopy, Tangent Single Use Digital Catheter. Model Numbers: (1) TNG4002-IND. (2) TNG-4007-6pk.
Codes / lots: (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
Reason for recall
Affected devices exhibited fractures at the distal shaft tip without complete detachment.
FDA-determined cause: Process control
Action taken
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
Details
- Recall number
- Z-2209-2026
- Initiated
- March 23, 2026
- Posted by FDA
- May 15, 2026
- Product code
- FBN – Choledochoscope And Accessories, Flexible/Rigid
- Quantity
- 53 units
- Distribution
- US Nationwide distribution in the states of North Carolina, Arizona, and Nevada.
- Recalling firm
- Tangent Endoscopy, LLC, Camden, DE