FDA-Device2026-05-27Class IIPROCESSING DEFECT
Tangent Endoscopy Single Use Digital Catheter recalled for shaft fracture risk
What this means
Tangent Endoscopy's Single Use Digital Catheter (models TNG4002-IND and TNG-4007-6pk) can develop fractures at the tip of the shaft during use. While the fractured pieces have not completely detached in reported cases, a broken catheter tip could affect device function or potentially cause patient harm.
- Check if you have affected catheters by model number: TNG4002-IND or TNG-4007-6pk, and lot numbers 2510900, 2512938, or 2601944.
- Do not use affected devices.
- Contact Tangent Endoscopy for instructions on returns or replacements.
The agency's original wording
Hazard
Affected devices exhibited fractures at the distal shaft tip without complete detachment.
Intended for
Adults
Illnesses reported
None reported
Sold states
US Nationwide distribution in the states of North Carolina, Arizona, and Nevada.
Affected count
53 units
Manufactured in
2140 S Dupont Hwy, Camden, DE, United States
Products
Tangent Endoscopy, Tangent Single Use Digital Catheter. Model Numbers: (1) TNG4002-IND. (2) TNG-4007-6pk.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2209-2026Want us to check the next one for you?
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