medical MODERATE Updated 2026-05-27

TANGENT ENDOSCOPY, LLC recalls Tangent Endoscopy, Tangent Single Use Digital Catheter. Mode

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Recalled Product

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

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Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
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

✅ What Should You Do?

  1. 1Contact your healthcare provider immediately to discuss this recall.
  2. 2Stop using the device if it is safe to do so, and contact your provider.
  3. 3Follow the manufacturer's remedy instructions provided in the recall notice.
  4. 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.
View official government recall