Stryker Corporation: Device Recall

Recall Details

Recall Number

Z-0601-2026

Classification

Class II

Product Type

Device

Recalling Firm

Stryker Corporation

Status

Ongoing

Date Initiated

10/31/2025

Location

Portage, MI, United States

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

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.

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;

Distribution Pattern

Worldwide distribution - US Nationwide and the countries of Australia, Belgium, Canada, England, Ireland, Italy, Kuwait, Singapore, Slovenia, Spain, and the Netherlands.

Other Recalls by Stryker Corporation

• Class II: Risk 10/31/2025
  Tape used to secure components within packaging contains latex, despite products being labeled as latex-free. Latex could potentially cause an allergic reaction.
• Class II: Risk 10/31/2025
  Tape used to secure components within packaging contains latex, despite products being labeled as latex-free. Latex could potentially cause an allergic reaction.
• Class II: Risk 07/02/2025
  Tourniquet cuff flange may become detached from the bladder. If leak occurs during the procedure, there may be risk of hemorrhage, resulting in blood loss greater than expected. Other serious risks include cerebral hypotension and cardiovascular collapse and arrest, risking stroke or death. Specific to IVRA, patient toxicity may also occur due to rapid systemic absorption of anesthetics.
• Class II: Risk 06/18/2025
  Due to complaints their is the potential that irrigation solution may leaked into the handpiece and battery pack causing it to malfunction.
• Class II: Risk 06/18/2025
  Due to complaints their is the potential that irrigation solution may leaked into the handpiece and battery pack causing it to malfunction.

View all recalls by Stryker Corporation →