Tangent Endoscopy, Tangent Single Use Digital Catheter. Model Numbers: (1) TNG4002-IND. (2) TNG-4007-6pk.
Summary
The FDA issued a Class II for Tangent Endoscopy, Tangent Single Use Digital Catheter. Model Numbers: (1) T by TANGENT ENDOSCOPY, LLC. Reason: Affected devices exhibited fractures at the distal shaft tip without complete detachment..
Details
Source
Device Recall
External ID
Z-2209-2026
Action Date
2026-05-27
Status
Ongoing
Category
device
Product Description
Tangent Endoscopy, Tangent Single Use Digital Catheter. Model Numbers: (1) TNG4002-IND. (2) TNG-4007-6pk.
Lot/Code Info: (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
Quantity Affected: 53 units
Reason for Recall
Affected devices exhibited fractures at the distal shaft tip without complete detachment.
Distribution
US Nationwide distribution in the states of North Carolina, Arizona, and Nevada.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-03-23
Company
Camden, DE
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 165 device recalls issued in the same week, part of 403 device-related FDA actions this month.
TANGENT ENDOSCOPY, LLC has 2 FDA actions in our database, including 1 recall and 1 clearance.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (TANGENT ENDOSCOPY, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does TANGENT ENDOSCOPY, LLC have FDA actions?
TANGENT ENDOSCOPY, LLC has 2 FDA actions in our database, including 1 recall and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2209-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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