Tangent Endoscopy, Tangent Single Use Digital Catheter.… recallZ-2209-2026 · Tangent Endoscopy, LLC · initiated Mar 23, 2026
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Tangent Endoscopy, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Affected devices exhibited fractures at the distal shaft tip without complete detachment.
FDA root cause category: Process control
What the company is doing
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 [email protected]
Recall details
- Recall number
- Z-2209-2026
- Status
- Open, Classified
- Initiated by the company
- Mar 23, 2026
- Posted by the FDA
- May 15, 2026
- Recalling firm
- Tangent Endoscopy, LLC
- Quantity
- 53 units
- Product code
- FBN
- FDA submissions
- K251170
- Distribution
- US Nationwide distribution in the states of North Carolina, Arizona, and Nevada.
Product description
Tangent Endoscopy, Tangent Single Use Digital Catheter. Model Numbers: (1) TNG4002-IND. (2) TNG-4007-6pk.
Code information (models, lots, serial numbers)
(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
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Tangent Digital catheter tng-4002-indTangent Endoscopy LLC · Choledochoscope And Accessories, Flexible/Rigid1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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