Z-2769-2015Class II

Voyant Open Fusion Device Models: EB040 and EB040+

Name: Z-2769-2015 Voyant Open Fusion Device Models: EB040 and EB040+
Creator: Applied Medical Resources Corp
Published: 2015-07-31
License: https://open.fda.gov/license/

Applied Medical Resources Corp / initiated 2015-07-31 / Terminated / root cause: design

FDA source

Applied Medical Resources Corp began a recall of Voyant Open Fusion Device Models: EB040 and EB040+ Product Usage: The Applied Voyant Open Fusion Device is designed for use with the Voyant Electrosurgical... on 2015-07-31. FDA classified it as Class II and gives the reason as "Potential to improperly characterize tissue within the jaws, which may result in nonoptimal power delivery". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2769-2015
Classification: Class II
Status: Terminated
Initiated: 2015-07-31
Posted: 2015-09-15
Terminated: 2015-11-20
Recalling firm: Applied Medical Resources Corp
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.
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
Reason for recall: Potential to improperly characterize tissue within the jaws, which may result in nonoptimal power delivery.
Root cause tag: design
FDA root cause: Device Design
Action: The firm sent out customer notification letters to International customers the beginning of July 31st, 2015 and domestic customers the week of August 3rd, 2015. The firm's letter requested customers complete the following actions: - check inventory for recalled product - complete the attached Recall Notification Confirmation Form to acknowledge the recall and indicate if facility is returning or has already used any of the products - Return the confirmation form(s) to Applied Medical by emailing to [email protected] or faxing to (949) 713-8936. - Return affected product and a copy of the confirmation form(s) to Applied Medical For product return questions contact Karen Mitchell, Sales Operations Supervisor, RGA Dept. at (949) 713-8622 or by e-mail at [email protected]. For regulatory questions contact Lauren Contursi, at (949) 713-8767 or by e-mail at [email protected].
Quantity in commerce: 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.
Product codes and lots: Model Number: EB040 Lot Numbers: 1243964, 1243975, 1244125 Model Number: EB040+ Lot Numbers: 1245512, 1245513, 1246241, 1246508, 1247079, 1247566, 1248102, 1249264

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2769-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2769-2015	Class II	Terminated	Voluntary: Firm initiated	2015-09-23	2015-09-15

Product code GEI

K143517Class IIVoyant Open Sealer-Divider DeviceApplied Medical Resources / cleared 2015-03-27

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)