Tangent Endoscopy, Tangent Single Use Digital Catheter. Model Numbers: (1) TNG4002-IND. (2) TNG-4007-6pk.
FDA Recall Z-2209-2026 · Posted 2026-05-15
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Recalling FirmTANGENT ENDOSCOPY, LLC
Recall StatusOpen, Classified
Product CodeFBN
Date Initiated2026-03-23
Product Quantity53 units
Reason for Recall
Affected devices exhibited fractures at the distal shaft tip without complete detachment.
Firm 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
[email protected]
Root Cause
Process control
Distribution Pattern
US Nationwide distribution in the states of North Carolina, Arizona, and Nevada.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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