Class II — TANGENT ENDOSCOPY, LLC
| Recalling firm | Tangent Endoscopy, LLC |
|---|---|
| Registered facility | TANGENT ENDOSCOPY, LLC (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Affected devices exhibited fractures at the distal shaft tip without complete detachment. |
| Product | Tangent Endoscopy, Tangent Single Use Digital Catheter. Model Numbers: (1) TNG4002-IND. (2) TNG-4007-6pk. |
| Quantity | 53 units |
| Distribution | US Nationwide distribution in the states of North Carolina, Arizona, and Nevada. |
| Initiated | 2026-03-23 |
| Classified | 2026-05-15 |
| Recall number | Z-2209-2026 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — TANGENT ENDOSCOPY, LLC (Z-2209-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/98654/
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