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;
Tape used to secure components within packaging contains latex, despite products being labeled as latex-free. Latex could potentially cause an allergic reaction.
From the FDA notice · Read the official notice ↗ · All Stryker recalls
What to do
The agency's notice has the remedy and who to contact.
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- 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;
- Sold in
- Nationwide
- Made for
- Adults (0 months and older)
This recall covers 3 products — see all of them.
Details
- Units affected
- 39,148
- Illnesses reported
- None reported
- Manufactured in
- 1941 Stryker Way, N/A, Portage, MI, United States
- Classification
- Class II
- Recall number
- Z-0601-2026
In the FDA's words
- 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; Tape used to secure components within packaging contains latex, despite products being labeled as latex-free. Latex could potentially cause an allergic reaction. 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 Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Belgium, Canada, England, Ireland, Italy, Kuwait, Singapore, Slovenia, Spain, and the Netherlands. Affected quantity: 39,148
- Hazard
- Tape used to secure components within packaging contains latex, despite products being labeled as latex-free. Latex could potentially cause an allergic reaction.
3 products in this recall
NICO surgical products recalled for latex in packaging tape
Stryker is recalling three NICO product lines: Myriad handpieces, Myriad illumination packs, and BrainPath Shephard's hooks. The packaging tape used to secure components contains latex, even though the products are labeled latex-free. Latex can cause an allergic reaction in people who are sensitive to it. No injuries have been reported.
The agency lists each product separately. Check every one you might have.
- NICO 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-80…Z-0599-2026 · 39,148
- NICO Myriad Illumination Pack Product No. NN-1000 11g Illumination Sleeve/Fiber; Product No. NN-1001 13g Illumination Sleeve/FiberZ-0600-2026 · 39,148
- NICO BrainPath; Product Number/Product Name NN-8024 BrainPath Shephard's Hook - Greenberg; NN-8025 BrainPath Shephard's Hook - Sugita; NN-8026 Brain… (this page)Z-0601-2026 · 39,148