CLASS II Device recall · Reported 23 Sep 2015 · FDA Enforcement Report

Myriad Console recalled by Nico

Nico is recalling NICO Myriad Console, distributed in California, Indiana, Maryland, North Carolina. The recall was initiated on 29 Jul 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel number NN-7000 SN: 00231, 00232, 00242, 00245, 00248, 00250

Quantity recalled6 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2767-2015
FDA event ID: 72015
Recalling firm: Nico, Indianapolis, IN
Classification: Class II
Status: Terminated
Recall initiated: 29 Jul 2015
FDA classified: 15 Sep 2015
Reported: 23 Sep 2015
Type: Voluntary: Firm initiated
Customers notified by: FAX
Reason category: Device Malfunction
Device type: Surgical Instruments

Timeline

29 Jul 2015	Recall initiated by company
15 Sep 2015	Classified by FDA	+48 days
23 Sep 2015	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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.

Where it was distributed

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

California Indiana Maryland North Carolina

Questions about this recall

Is Myriad Console recalled?

Yes. Nico recalled Myriad Console on 29 Jul 2015. The recall is Class II and its status is Terminated. Recall number Z-2767-2015.

Why was it recalled?

Which lots are affected?

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

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Nico

All 7

Reported	Class	Recall	Company	Reason	Where
16 Jun 2021Device	CLASS II	Myriad-LX Illumination Pack recalled by Nico	Nico	Other	Nationwide
16 Jun 2021Device	CLASS II	Myriad-LX Light Source-for delivery of light to recalled by Nico	Nico	Other	Nationwide
22 Aug 2018Device	CLASS II	Shepherd' s Hook - Greenberg, sterile recalled by Nico	Nico	Labeling Errors	Nationwide
29 Jun 2016Device	CLASS II	Myriad handpiece Tissue morcellator recalled by Nico	Nico	Device Malfunction	13 states
22 Aug 2012Device	CLASS II	BrainPath Sheath The NICO BrainPath is a family of products recalled	Nico	Labeling Errors	MI

Other Surgical Instruments recalls

All 3,809

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Device	CLASS II	Medline Convenience Kits: IV Start KIT recalled by Medline Industries	Medline Industries	Sterility	Nationwide
9 Sep 2026Device	CLASS II	Medline Convenience Kits containing BD ChloraPrep Clear recalled	Medline Industries	Lead & Heavy Metals	Nationwide
2 Sep 2026Device	CLASS II	Medline convenience kits labeled as: Open Heart Pack, Medline Kit recalled	Medline Industries	Other	Nationwide
2 Sep 2026Device	CLASS II	Medline convenience kits labeled as: GYN Robotic CDS, Medline Kit recalled	Medline Industries	Other	Nationwide
2 Sep 2026Device	CLASS II	Linvatec Genesys CrossFT Suture Anchor with Disposable Driver recalled	ConMed	Sterility	Nationwide