NICO BrainPath recallZ-0601-2026 · 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-0601-2026
- 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
- 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 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; NN-8042 BrainPath Shephard's Hook - Greenberg LK;
Code information (models, lots, serial numbers)
Product Number/UDI-DI (GTIN)/Lot Numbers: NN-8024 00816744028244 37AI2944 37AJ2013 37BD3753 37BD3778 37CA1605 37CB3738 37CH0636 37CI1919 37EH0405 37FC3059 37FD0154 37GA4512 37GH1715 37GI0110 37GJ1623 37HB0029 37HH2313 37HI1536 37HI1631 37IA7694 37ID4162 37IG2900 37JB1413 37JH0131 37JH2903 37KG1406 37KH2953 37LA0708 37LG1834; NN-8025 00816744028251 37BB2326 37BJ1836 37CH0640 37DC0545 37HD2766 37KB3677 37KJ1139; NN-8026 00816744028268 37BJ1837 37CC7852 37CH0643 37DJ1056; NN-8042 07613327663280 37CC9220 37ED9408 37FJ2202 37II2308 37LD8666
Devices named in this recall
3 devices in the FDA device registry whose identifier appears in the recall's code information.
- NICO BrainPath NN-8024Nico Corporation · Hook, Surgical, General & Plastic Surgery1 recall0 reports
- NICO BrainPath NN-8025Nico Corporation · Hook, Surgical, General & Plastic Surgery1 recall0 reports
- NICO BrainPath NN-8026Nico Corporation · Hook, Surgical, General & Plastic Surgery1 recall0 reports
Product lines
Other devices under the same FDA submission
2 devices cleared under K191599 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- NICO Myriad-LX NN-1000Nico Corporation · Neurological Tray1 recall0 reports
- NICO Myriad-LX NN-1001Nico Corporation · Neurological Tray1 recall0 reports
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-0600-2026 · Open, ClassifiedNICO Myriad Illumination Pack Product No. NN-1000 11g Illumination Sleeve/Fiber; Product No. NN-1001 13g Illumination Sleeve/Fiber
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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