Myriad handpiece Tissue morcellator — Class II medical device recall Z-2045-2016
Terminated recall by Nico Corp., reported 2016-06-29, distributed in AR, CA, GA, IA, IL, IN, MD, MI…. This recall has been initiated due to a defective component within the handpiece which will cause the handpiec
| Recall number | Z-2045-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Nico Corp., Indianapolis, IN, United States |
| Recall initiated | 2014-02-24 |
| Classified | 2016-06-21 |
| Reported by FDA | 2016-06-29 |
| Terminated | 2016-06-28 |
| Distributed | AR, CA, GA, IA, IL, IN, MD, MI, NC, OH, OR, TX, WI |
| Quantity | 63 units |
| Lot numbers | 1444664, 1508994 |
| Model numbers | 1444664, 1508994, NN-8004 |
Product
Myriad handpiece Tissue morcellator
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2045-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.