NICO Myriad-LX recallZ-0600-2026 · Stryker Corporation · initiated Oct 31, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Stryker Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Tape used to secure components within packaging contains latex, despite products being labeled as latex-free. Latex could potentially cause an allergic reaction.
FDA root cause category: Under Investigation by firm
What the company is doing
On October 31, 2025, the firm began notifying impacted customers through Urgent Medical Device Recall letters. Customers were instructed to mark affected product with "CONTAINS LATEX" and place a copy of the notice at the product's storage location before use. Product returns are not required. However, customers who would like to receive a replacement were given options to destroy or return product for a replacement.
Recall details
- Recall number
- Z-0600-2026
- Status
- Open, Classified
- Initiated by the company
- Oct 31, 2025
- Posted by the FDA
- Nov 26, 2025
- Recalling firm
- Stryker Corporation
- Quantity
- 39,148
- Product code
- GEI
- FDA submissions
- K191599, K232567
- Distribution
- Worldwide distribution - US Nationwide and the countries of Australia, Belgium, Canada, England, Ireland, Italy, Kuwait, Singapore, Slovenia, Spain, and the Netherlands.
Product description
NICO Myriad Illumination Pack Product No. NN-1000 11g Illumination Sleeve/Fiber; Product No. NN-1001 13g Illumination Sleeve/Fiber
Code information (models, lots, serial numbers)
Product Number/UDI-DI (GTIN)/Lot Numbers: NN-1000 00816744021009 37AC5163 37AE9811 37AJ1438 37BJ0513 37CB3410 37CB3416 37CD6003 37CE3030 37EB5720 37FA4260 37GD2216 37GJ1603 37IC7023 37IJ0208 37JJ0122 37KI1300 37LA0158 37LI0320 37LJ1522; NN-1001 00816744021016 37AC5177 37AE9942 37AE9955 37AJ1439 37BJ0516 37CB3380 37CB3419 37CD6005 37CJ0204 37DE4864 37EB5721 37FA4261 37GD2219 37GJ1607 37IC7027 37IJ0209 37JD5753 37JJ0123 37KI1301 37LA0159 37LI0322 37LJ1525
Devices named in this recall
2 devices in the FDA device registry whose identifier appears in the recall's code information.
- NICO Myriad-LX NN-1000Nico Corporation · Neurological Tray1 recall0 reports
- NICO Myriad-LX NN-1001Nico Corporation · Neurological Tray1 recall0 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 97833).
- Z-0599-2026 · Open, ClassifiedNICO Myriad Handpiece Product Number/Product Name: NN-8000 15x10 MHP; NN-8001 15x 13 MHP; NN-8002 15x 25 MHP - MINOP; NN-8003 13x10 MHP; NN-8004 13x13 MHP; NN-8005 15x25 MHP GAA…
- Z-0601-2026 · Open, ClassifiedNICO BrainPath; Product Number/Product Name NN-8024 BrainPath Shephard's Hook - Greenberg; NN-8025 BrainPath Shephard's Hook - Sugita; NN-8026 BrainPath Shephard's Hook - Budde; N…
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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