Voyant Open Fusion Device Models: EB040 and EB040+ Product Usage: The… — Class II medical device recall Z-2769-2015
Terminated recall by Applied Medical Resources Corp, reported 2015-09-23, distributed nationwide. Potential to improperly characterize tissue within the jaws, which may result in nonoptimal power delivery.
| Recall number | Z-2769-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Applied Medical Resources Corp, Rancho Santa Margarita, CA, United States |
| Recall initiated | 2015-07-31 |
| Classified | 2015-09-15 |
| Reported by FDA | 2015-09-23 |
| Terminated | 2015-11-20 |
| Distributed | Nationwide (US) |
| Countries outside the US | ES, FR, GB, NL |
| Lot numbers | 1243964, 1243975, 1244125, 1245512, 1245513, 1246241, 1246508, 1247079, 1247566, 1248102, 1249264 |
| Model numbers | EB040 |
Product
Voyant Open Fusion Device Models: EB040 and EB040+ Product Usage: The Applied Voyant Open Fusion Device is designed for use with the Voyant Electrosurgical Generator. The device is an advanced bipolar instrument that uses RF energy, provided by the generator, to seal vessels up to and including 5mm (EB040+) or 7mm (EB040) in diameter. The device may also be used to seal tissue bundles that can be captured in the device jaws. The system delivers the energy required to fuse the tissue between the jaws of the device by monitoring voltage and current throughout the seal cycle. The device also features a useractuated blade for the transection of sealed tissue.
Reason for recall
Potential to improperly characterize tissue within the jaws, which may result in nonoptimal power delivery.
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-2769-2015. 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.