FDA Medical Device Recalls (openFDA)
TANGENT ENDOSCOPY, LLC: Tangent Endoscopy, Tangent Single Use Digital Catheter. Model Numbers: (1) TNG4002-IND. (2) TNG-4007-6pk.
- Recall number
- Z-2209-2026
- Recalling firm
- TANGENT ENDOSCOPY, LLC
- Product
- Tangent Endoscopy, Tangent Single Use Digital Catheter. Model Numbers: (1) TNG4002-IND. (2) TNG-4007-6pk.
- Status
- Open, Classified
- Initiated
- 2026-03-23
- Posted
- 2026-05-15
- Terminated
- not on file
- Reason
- Affected devices exhibited fractures at the distal shaft tip without complete detachment.
- Root 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
- 53 units
- Distribution
- US Nationwide distribution in the states of North Carolina, Arizona, and Nevada.
- Lot, serial or model codes
- (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
- 510(k) numbers
- K251170
- PMA numbers
- not on file
- Product code
- FBN
- Firm FEI
- 3041659934
- Firm city
- Camden
- Firm state
- DE
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28