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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 72015

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

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Event summary

Timeline bucket
July 29, 2015
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Nico 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.

How coverage and grouping work

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

NICO Myriad Console Model number NN-7000 The Myriad System is a surgical system specifically designed for morcellation of soft tissue. It primarily consists of a reusable console with foot pedal and a disposable handpiece. For the morcellation and removal of tissue during pelviscopic, laparoscopic, percutaneous and open surgical procedures whenever access to the surgical site is limited.

Z-2767-2015
Recall number
Z-2767-2015
Initiated
July 29, 2015
Classification
Class II
Status
Terminated
Recalling firm
Nico Corp.
Quantity
6 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Two cables within the console were inadvertently twisted during manufacturing. The individual wires within the cables may break and/or contact one another where the cables terminate into two connectors. When these wires break or contact one another (i.e., short), various types of malfunction may occur with the console. One type of malfunction may result in unexpected aspiration increase.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Two cables within the console were inadvertently twisted during manufacturing. The individual wires within the cables may break and/or contact one another where the cables terminate into two connectors. When these wires break or contact one another (i.e., short), various types of malfunction may occur with the console. One type of malfunction may result in unexpected aspiration increase.

Code information

Model number NN-7000 SN: 00231, 00232, 00242, 00245, 00248, 00250

Distribution pattern

US Distribution to states of: MD, IN, CA, and NC.