Z-2209-2026Class II

Tangent Endoscopy, Tangent Single Use Digital Catheter. Model Numbers: (1) TNG4002-IND. (2) TNG-4007-6pk

Name: Z-2209-2026 Tangent Endoscopy, Tangent Single Use Digital Catheter. Model Numbers: (1) TNG4002-IND. (2) TNG-4007-6pk
Creator: Tangent Endoscopy, Llc
Published: 2026-03-23
License: https://open.fda.gov/license/

Tangent Endoscopy, LLC / initiated 2026-03-23 / Open, Classified / root cause: manufacturing process

FDA source

TANGENT ENDOSCOPY, LLC began a recall of Tangent Endoscopy, Tangent Single Use Digital Catheter. Model Numbers: (1) TNG4002-IND. (2) TNG-4007-6pk on 2026-03-23. FDA classified it as Class II and gives the reason as "Affected devices exhibited fractures at the distal shaft tip without complete detachment". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2209-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-03-23
Posted: 2026-05-15
Recalling firm: Tangent Endoscopy, LLC
Product: Tangent Endoscopy, Tangent Single Use Digital Catheter. Model Numbers: (1) TNG4002-IND. (2) TNG-4007-6pk.
Product code: FBN Choledochoscope And Accessories, Flexible/Rigid
Reason for recall: Affected devices exhibited fractures at the distal shaft tip without complete detachment.
Root cause tag: manufacturing process
FDA 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 [email protected]
Quantity in commerce: 53 units
Distribution: US Nationwide distribution in the states of North Carolina, Arizona, and Nevada.
Product codes and 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2209-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2209-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-05-27	2026-05-15

Product code FBN

K251170Class IITangent Single-Use Digital System: Tangent Single-Use Digital Catheter and Tangent Digital ControllerTangent Endoscopy, LLC / cleared 2025-09-12

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)