FDA recall, , Moderate risk
Tangent Endoscopy Single Use Digital Catheter
The Tangent Single Use Digital Catheter can fracture at the distal shaft tip.
Summary by Recall Canary from the FDA notice
What happened
TANGENT ENDOSCOPY, LLC, of Camden, Delaware, recalled the Tangent Single Use Digital Catheter after affected devices exhibited fractures at the distal shaft tip without complete detachment. The FDA added the recall to its Enforcement Report on May 15, 2026, and the company began the recall on March 23, 2026.
The recalled devices include the Tangent Single Use Digital Catheter. The recall covers 53 units distributed nationwide in the states of North Carolina, Arizona, and Nevada.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Affected if its model number, UDI-DI and lot code are listed under that product.
A UDI-DI is the device identifier printed with the barcode on the device label.
Tangent Single Use Digital Catheter
- Model number
- TNG4002-IND
- TNG-4007-6pk
- UDI-DI
- 00850061601001
- Lot code
- 2510900
- 2512938
- 2601944
Recall details
- Company began the recall
- Sold in
US Nationwide distribution in the states of North Carolina, Arizona, and Nevada.
- Company
- TANGENT ENDOSCOPY, LLCCamden, Delaware
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98654
- Recall number
- Z-2209-2026
- Quantity recalled
- 53 units
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
