NICO BrainPath; Product Number/Product Name NN-8024 BrainPath Shephard's Hook - Greenberg; NN-8025 BrainPath Shep
Summary
The FDA issued a Class II for NICO BrainPath; Product Number/Product Name NN-8024 BrainPath Shephard's Ho by Stryker Corporation. Reason: Tape used to secure components within packaging contains latex, despite products being labeled as latex-free. Latex could potentially cause an allergi.
Details
Source
Device Recall
External ID
Z-0601-2026
Action Date
2025-12-03
Status
Ongoing
Category
device
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;
Lot/Code Info: 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
Quantity Affected: 39,148
Reason for Recall
Tape used to secure components within packaging contains latex, despite products being labeled as latex-free. Latex could potentially cause an allergic reaction.
Distribution
Worldwide distribution - US Nationwide and the countries of Australia, Belgium, Canada, England, Ireland, Italy, Kuwait, Singapore, Slovenia, Spain, and the Netherlands.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-10-31
Company
Portage, MI
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 254 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Stryker Corporation has 98 FDA actions in our database, including 90 recalls and 8 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Stryker Corporation) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Stryker Corporation have FDA actions?
Stryker Corporation has 98 FDA actions in our database, including 90 recalls and 8 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0601-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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