TANGENT ENDOSCOPY, LLC recalls Tangent Endoscopy
- Recalling company
- TANGENT ENDOSCOPY, LLC
- Product
- Tangent Endoscopy, Tangent Single Use Digital Catheter. Model Numbers: (1) TNG4002-IND. (2) TNG-4007-6pk.
- Reason
- Affected devices exhibited fractures at the distal shaft tip without complete detachment.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Mar 23, 2026
- Reported
- May 27, 2026
- Distribution
- US Nationwide distribution in the states of North Carolina, Arizona, and Nevada.
- Status
- Ongoing
- Quantity
- 53 units
- Lot / codes
- (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
- Company location
- Camden, DE
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-2209-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-2209-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.