FDAFDA · Food and drugs·Recall number Z-2209-2026
Tangent Endoscopy, Tangent Single Use Digital Catheter. Model Numbers: (1) TNG4002-IND. (2) TNG-4007-6pk.
Published May 27, 2026 · Recall initiated: March 23, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Affected devices exhibited fractures at the distal shaft tip without complete detachment.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- TANGENT ENDOSCOPY, LLC
- Distributor
- US Nationwide distribution in the states of North Carolina, Arizona, and Nevada.
- Lot
- (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
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.