Reported May 27, 2026 · Ongoing

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

Tangent Endoscopy, LLC

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: TANGENT ENDOSCOPY, LLC · 2140 S Dupont Hwy · Camden, DE · 19934-1249

Is this the product you have?

  • Tangent Endoscopy, Tangent Single Use Digital Catheter
  • Model Numbers(1) TNG4002-IND. (2) TNG-4007-6pk
Lot codes and dates
  • (1)
  • Model NumberTNG4002-IND
  • UDI-DI(1) 00850061601001
  • Lot numbers
    • 2510900
    • 2512938
    • and 2601944. (2)
  • Model NumberTNG-4007-6pk
  • UDI-DI00850061601001
  • Lot numbers
    • 2510900
    • 2512938
    • and 2601944
Amount recalled
53 units

Where it was sold

Why it was recalled

Affected devices exhibited fractures at the distal shaft tip without complete detachment.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 6:55 PM UTC

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