Z-0601-2026Class II

NICO BrainPath; Product Number/Product Name NN-8024 BrainPath Shephard's Hook - Greenberg; NN-8025 BrainPath...

Name: Z-0601-2026 NICO BrainPath; Product Number/Product Name NN-8024 BrainPath Shephard's Hook - Greenberg; NN-8025 BrainPath...
Creator: Stryker Corporation
Published: 2025-10-31
License: https://open.fda.gov/license/

Stryker Corp. / initiated 2025-10-31 / Open, Classified / root cause: labeling and UDI

FDA source

Stryker Corporation began a recall of NICO BrainPath; Product Number/Product Name NN-8024 BrainPath Shephard's Hook - Greenberg; NN-8025 BrainPath Shephard's Hook - Sugita; NN-8026 BrainPath... on 2025-10-31. FDA classified it as Class II and gives the reason as "Tape used to secure components within packaging contains latex, despite products being labeled as latex-free. Latex could potentially cause an allergic reaction". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0601-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-10-31
Posted: 2025-11-26
Recalling firm: Stryker Corp.
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;
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
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.
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: 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.
Quantity in commerce: 39,148
Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Belgium, Canada, England, Ireland, Italy, Kuwait, Singapore, Slovenia, Spain, and the Netherlands.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0601-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0599-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-12-03	2025-11-26
Z-0600-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-12-03	2025-11-26
Z-0601-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-12-03	2025-11-26

Product code GEI

K191599Class IINICO Myriad NOVUSNico Corporation / cleared 2019-09-13

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)