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Recall Canary
Tangent Single Use Digital Catheter
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MEDICAL DEVICE RECALLMODERATE

Tangent Single Use Digital Catheter

Tangent Endoscopy is recalling single-use digital catheters due to potential fractures at the distal shaft tip.

What to do

Immediately stop using the affected devices and contact Tangent Endoscopy for return and replacement instructions.

Recalled
Listed
Updated
Recall No.
Z-2209-2026
Agency
FDA
Firm
TANGENT ENDOSCOPY, LLC
Recall ID
98654
Status
ONGOING

Recall at a glance

Quantity recalled
53 units

Why it was recalled

Tangent Endoscopy is recalling specific single-use digital catheters due to reports of fractures occurring at the distal shaft tip. While the tip remains attached, these fractures may compromise device performance during endoscopic procedures.

Is mine affected?

Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.

Tangent Endoscopy, Tangent Single Use Digital Catheter. Model Numbers

UDI-DI
00850061601001, 00850061601001

Where it was sold

Distributed nationwide.

Timeline

  1. Firm initiated recall
  2. Publicly announced
  3. Listed on Recall Canary
  4. Summary updated
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Editorial summary by Recall Canary · summary updated 2026-06-11 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification