Stryker recalled 39,148 NICO BrainPath BrainPath Shephard's Hook devices distributed worldwide through multiple healthcare providers. latex-containing tape in packaging is the defect, despite latex-free labeling. Stop using the device now and follow recall instructions from Stryker or your healthcare provider.
Tape used to secure components within packaging contains latex, despite products being labeled as latex-free. Latex could potentially cause an allergic reaction.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Stryker Corporation or your healthcare provider for instructions. Notification method: Letter
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BrainPath is a neurosurgical retracting device used during cranial procedures to gently hold brain tissue. It is typically used by surgical teams in hospitals.
Latex in the packaging tape can cause an allergic reaction if exposed to patients or handlers. The hazard arises from a labeling mismatch with latex-containing components.
This recall is not indicated as part of a broader industry pattern.
The recall affects 39,148 units distributed globally. Hospitals and surgical centers must verify inventory and potentially replace packaging materials to prevent latex exposure during handling.
Recall notices are available via the FDA enforcement page linked in the recall notice and the manufacturer’s communications.
Refund or replacement details will be provided by Stryker through official recall channels. Processing times vary by facility.
Keep copy of the recall notice, model numbers, UDI-DI, lot numbers, and any correspondence with the manufacturer.
Product Line: NICO BrainPath Model Numbers: NN-8024, NN-8025, NN-8026, NN-8042 UDI-DI/GTIN and 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;
No injuries or incidents have been reported.
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