Tangent Endoscopy, Tangent Single Use Digital Catheter. Model Numbers: (1) TNG4002-IND. (2) TNG-4007-6pk.
FDA device recall Z-2209-2026 · posted 2026-05-15 · Open, Classified
Recall details
- Recalling firm
- TANGENT ENDOSCOPY, LLC
- Reason for recall
- Affected devices exhibited fractures at the distal shaft tip without complete detachment.
- 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
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- FBN
- Quantity affected
- 53 units
- Distribution
- US Nationwide distribution in the states of North Carolina, Arizona, and Nevada.
- Date initiated
- 2026-03-23
- Date posted
- 2026-05-15
- Location
- Camden, DE
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Tangent Single-Use Digital System: Tangent Single-Use Digital Catheter and Tangent Digital Controller (K251170) | Tangent Endoscopy, LLC | 2025-09-12 |