Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported September 23, 2015
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
Potential to improperly characterize tissue within the jaws, which may result in nonoptimal power delivery.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Applied Medical Resources Corp recalled Voyant Open Fusion Device Models: EB040 and EB040+ Product Usage: The Applied Voyant… - a moderate-severity action.
Voyant Open Fusion Device Models: EB040 and EB040+ Product Usage: The Applied Voyant… was recalled by Applied Medical Resources Corp in September 23, 2015. Reason: Potential to improperly characterize tissue within the jaws, which may result in nonoptimal power delivery.. Check the official notice for the remedy. Verify recall #Z-2769-2015 with the FDA Devices before acting.
The recall
Applied Medical Resources Corp issued this moderate-severity FDA Devices recall-Potential to improperly characterize tissue within the jaws, which may result in nonoptimal power delivery..
- Moderate
- severity level
- 101 units
- affected scope
- Class II
- classification
- September 23, 2015
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2769-2015 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2769-2015) was formally reported on September 23, 2015, with the manufacturer initiating the action on July 31, 2015. It is classified under Moderate severity (Class II), with a current status of Terminated. Applied Medical Resources Corp is listed as the recalling firm, operating out of Rancho Santa Margarita, CA. Federal records list the affected scope as 101 units (U.S) and 38 units (International).
The documented reason for this recall is: Potential to improperly characterize tissue within the jaws, which may result in nonoptimal power delivery. Distribution data in the federal record shows the product reached: Worldwide Distribution - U.S Nationwide in the states of:FL, GA, NV. and countries of: France, Netherlands, Spain, and United Kingdom.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
101 units (U.S) and 38 units (International)
Related Recalls
6
3 from same agency
Product description
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2769-2015 |
| Date reported | September 23, 2015 |
| Date initiated | July 31, 2015 |
| Recalling firm | Applied Medical Resources Corp |
| Firm location | Rancho Santa Margarita, CA |
| Affected scope | 101 units (U.S) and 38 units (International) |
| Distribution | Worldwide Distribution - U.S Nationwide in the states of:FL, GA, NV. and countries of: France, Netherlands, Spain, and United Kingdom. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2769-2015) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Applied Medical Resources Corp. Units affected: 101 units (U.S) and 38 units (International).
Why was this product recalled? ▼
Potential to improperly characterize tissue within the jaws, which may result in nonoptimal power delivery.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 23, 2015. Severity: Moderate. Recall number: Z-2769-2015.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - U.S Nationwide in the states of:FL, GA, NV. and countries of: France, Netherlands, Spain, and United Kingdom..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2769-2015) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported September 23, 2015. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.