Tangent Endoscopy — Class II medical device recall Z-2209-2026
Ongoing recall by TANGENT ENDOSCOPY, LLC, reported 2026-05-27, distributed nationwide. Affected devices exhibited fractures at the distal shaft tip without complete detachment.
| Recall number | Z-2209-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | TANGENT ENDOSCOPY, LLC, Camden, DE, United States |
| Recall initiated | 2026-03-23 |
| Classified | 2026-05-15 |
| Reported by FDA | 2026-05-27 |
| Distributed | Nationwide (US) |
| Quantity | 53 units |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 00850061601001 |
| Lot numbers | 2510900, 2512938, 2601944 |
| Model numbers | TNG-4007-6PK, TNG4002-IND |
Product
Tangent Endoscopy, Tangent Single Use Digital Catheter. Model Numbers: (1) TNG4002-IND. (2) TNG-4007-6pk.
Reason for recall
Affected devices exhibited fractures at the distal shaft tip without complete detachment.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2209-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.