Tangent Endoscopy, Tangent Single Use Digital Catheter. Model Numbers: (1) TNG4002-IND. (2) TNG-4007-6pk.
Class I - DangerousWhat Should You Do?
- Check if you have this product: (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
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- TANGENT ENDOSCOPY, LLC
- Reason for Recall:
- Affected devices exhibited fractures at the distal shaft tip without complete detachment.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Tangent Endoscopy, Tangent Single Use Digital Catheter. Model Numbers: (1) TNG4002-IND. (2) TNG-4007-6pk.
Product Codes/Lot Numbers:
(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
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2209-2026