- Recalling firm
- TANGENT ENDOSCOPY, LLC
- Reason for recall
- Affected devices exhibited fractures at the distal shaft tip without complete detachment.
- Affected products (lot / model / serial)
- (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
- Units affected
- 53 units
- Distribution pattern
- US Nationwide distribution in the states of North Carolina, Arizona, and Nevada.
- Firm location
- Camden, DE, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- E-Mail
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-2209-2026
- Recall initiated
- March 23, 2026
- FDA classification date
- May 15, 2026
- FDA report date
- May 27, 2026
- FDA event ID
- 98654
- Last updated on HTM Vibe
- July 24, 2026