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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 71956

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
July 31, 2015
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Applied Medical Resources Corp

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

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Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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.

Z-2769-2015
Recall number
Z-2769-2015
Initiated
July 31, 2015
Classification
Class II
Status
Terminated
Quantity
101 units (U.S) and 38 units (International)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential to improperly characterize tissue within the jaws, which may result in nonoptimal power delivery.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

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Inspect official wording and provenance

Reason for recall

Potential to improperly characterize tissue within the jaws, which may result in nonoptimal power delivery.

Code information

Model Number: EB040 Lot Numbers: 1243964, 1243975, 1244125 Model Number: EB040+ Lot Numbers: 1245512, 1245513, 1246241, 1246508, 1247079, 1247566, 1248102, 1249264

Distribution pattern

Worldwide Distribution - U.S Nationwide in the states of:FL, GA, NV. and countries of: France, Netherlands, Spain, and United Kingdom.