Nico Corp. Recalls Myriad Handpiece Tissue Morcellators Due to Defective Component
Nico Corp. is recalling 63 units of Myriad handpiece tissue morcellators because a defective component causes the device to fail and become non-functional.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard is a functional failure of the device that renders it non-functional, without reported injuries or deaths, fitting the criteria for a moderate severity recall.
Plain-English summary
Nico Corp. is recalling 63 units of the Myriad handpiece tissue morcellator, part number NN-8004, lots 1444664 and 1508994. The recall was initiated because a defective component within the handpiece causes the device to fail. This failure results in the inability to cut tissue, rendering the handpiece non-functional.
The affected units were distributed in the United States to the states of Oregon, Illinois, Iowa, North Carolina, Texas, California, Georgia, Ohio, Wisconsin, Arkansas, Michigan, Maryland, and Indiana. The specific product code is 13ga, 13cm.
If the failure occurs, a replacement Myriad handpiece will be required. If a replacement handpiece is not available, alternate instrumentation for tissue removal will be necessary. Users should contact the recalling firm for further instructions.
The recalled product
- Product
- Myriad handpiece Tissue morcellator
- Manufacturer
- Nico Corp.
- Hazard
- Affected units
- 63
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- 13ga
- 13cm Myriad Handpiece Part number: NN-8004 Lots 1444664 and 1508994
Distribution
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