Severity
Moderate
FDA Devices recall · Reported September 23, 2015
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 termina…
Nico Corp. recalled NICO Myriad Console Model number NN-7000 The Myriad System is a surgical system spec… - a moderate-severity action.
NICO Myriad Console Model number NN-7000 The Myriad System is a surgical system spec… was recalled by Nico Corp. in September 23, 2015. Reason: Two cables within the console were inadvertently twisted during manufacturing. The individual wires within th…. Check the official notice for the remedy. Verify recall #Z-2767-2015 with the FDA Devices before acting.
The recall
Nico Corp. issued this moderate-severity FDA Devices recall-Two cables within the console were inadvertently twisted during manufacturing. The individual wires within th….
Sourced from official FDA Devices enforcement records. Verify recall #Z-2767-2015 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
This FDA Devices action (record #Z-2767-2015) was formally reported on September 23, 2015, with the manufacturer initiating the action on July 29, 2015. It is classified under Moderate severity (Class II), with a current status of Terminated. Nico Corp. is listed as the recalling firm, operating out of Indianapolis, IN. Federal records list the affected scope as 6 units.
The documented reason for this recall is: 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… Distribution data in the federal record shows the product reached: US Distribution to states of: MD, IN, CA, and NC.. 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.
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.
Severity
Moderate
Affected scope
6 units
Related Recalls
6
3 from same agency
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.
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.
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2767-2015 |
| Date reported | September 23, 2015 |
| Date initiated | July 29, 2015 |
| Recalling firm | Nico Corp. |
| Firm location | Indianapolis, IN |
| Affected scope | 6 units |
| Distribution | US Distribution to states of: MD, IN, CA, and NC. |
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.
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.
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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.