FDA Medical Device Recalls (openFDA)
Nico Corp.: Myriad handpiece Tissue morcellator
- Recall number
- Z-2045-2016
- Recalling firm
- Nico Corp.
- Product
- Myriad handpiece Tissue morcellator
- Status
- Terminated
- Initiated
- 2014-02-24
- Posted
- not on file
- Terminated
- 2016-06-28
- Reason
- This recall has been initiated due to a defective component within the handpiece which will cause the handpiece to fail. The failure will result in the inability to cut tissue with the handpiece, rendering it non-functional. Should this failure occur, a replacement Myriad handpiece will be required. If a replacement handpiece is not available, alternate instrumentation for tissue removal will be necessary.
- Root cause
- Device Design
- Action
- NICO sent an Urgent: NICO Myriad Handpiece Recall Notification on February 24, 2014, to all affected customers requesting return of the affected product. The recall notification included a description of the reason for the recall, affected product, customer responsibilities, and instructions for responding to the formal recall notification. If you have any questions regarding this matter, please call (317) 660-7118, ext. 104.
- Quantity
- 63 units
- Distribution
- US Distribution to the states of : OR, IL, IA, NC, TX, CA, GA, OH, WI, AR, MI, MD, IN.
- Lot, serial or model codes
- 13ga, 13cm Myriad Handpiece Part number: NN-8004 Lots 1444664 and 1508994
- 510(k) numbers
- ["K955168"]
- PMA numbers
- not on file
- Product code
- GEY
- Firm FEI
- 3007456622
- Firm city
- Indianapolis
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28