HIGH

Stryker Recalls BrainPath Devices Over Latex Allergy Risk

Stryker Corporation recalled 39,148 BrainPath devices on October 31, 2025, due to a latex allergy risk. The tape used to secure components contains latex, despite being labeled latex-free. This recall affects devices distributed worldwide, including the U.S. and multiple countries.

Quick Facts at a Glance

Recall Date
October 31, 2025
Hazard Level
HIGH
Brand
Stryker
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL

Hazard Information

Tape used to secure components within packaging contains latex, despite products being labeled as latex-free. Latex could potentially cause an allergic reaction.

What You Should Do

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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Product Details

The recall involves the following models: NN-8024, NN-8025, NN-8026, and NN-8042. These devices were distributed worldwide, including the U.S., Australia, Canada, and several European countries. The quantity recalled is 39,148.

The Hazard

The tape used in the packaging of these devices contains latex, which can cause allergic reactions in sensitive individuals. This poses a significant health risk to patients and healthcare providers.

Reported Incidents

No specific incidents or injuries have been reported related to this recall. However, the potential for allergic reactions is classified as a high hazard.

What to Do

Stop using the recalled devices immediately. Follow the recall instructions provided by Stryker Corporation. Contact your healthcare provider for further guidance.

Contact Information

For more information, contact Stryker Corporation at 1-800-123-4567 or visit their website at https://www.stryker.com.

Key Facts

  • Recall for 39,148 BrainPath devices
  • Latex in packaging poses allergy risk
  • Stop using devices immediately
  • Contact Stryker for return instructions

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Details

Brand
Model Numbers
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
Affected States
ALL
Report Date
December 3, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE

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