Fuse 1C Colonoscope — Class II medical device recall Z-0694-2016
Terminated recall by EndoChoice, Inc., reported 2016-02-03, distributed nationwide. The bending section of the device may partially separate from the insertion tube. Potential for tissue trauma.
| Recall number | Z-0694-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | EndoChoice, Inc., Alpharetta, GA, United States |
| Recall initiated | 2015-12-18 |
| Classified | 2016-01-27 |
| Reported by FDA | 2016-02-03 |
| Terminated | 2016-03-24 |
| Distributed | Nationwide (US) |
| Countries outside the US | CH, CO, DE, DK, ES, FR, ID, IL, IT, JP, KR, MY |
| Quantity | 253 units |
| Serial numbers | 0600200, 0600201, 0600202, 0600203, 0600204, 0600205, 0600206, 0700200, 0700204, 0700205, 0700207, 0700209, 0700210, 0700212, 0700215, 0700217, F1C0201FUSE1C-133, F1C0202FUSE1C-133, F1C0202FUSE1C-150, F1C0203FUSE1C-133, F1C0203FUSE1C-150, F1C0204FUSE-133, F1C0204FUSE1C-150, F1C0205FUSE1C-133, F1C0205FUSE1C-150 and 228 more |
| Model numbers | C38S, C38S-150, F1C, F1C-MC90, FDC-3300-133, FSC-330-C6333, FSC-3300-150, FSC-3300-SL, FSC-3300-ST, FSC330-A6334 |
Product
Fuse 1C Colonoscope
Reason for recall
The bending section of the device may partially separate from the insertion tube. Potential for tissue trauma.
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-0694-2016. 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.