Brain access devices recalled because packaging tape contains latex
Stryker is recalling 39,148 NICO BrainPath devices because tape used to secure components in the packaging contains latex despite the products being labelled latex-free.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Scored 3 under the risk-of-harm criterion: undisclosed latex in a product labelled latex-free can trigger an allergic reaction, and no injuries are reported.
Plain-English summary
The NICO BrainPath is being recalled across product numbers NN-8024, NN-8025, NN-8026 and NN-8042, the BrainPath Shephard's Hook range.
Tape used to secure components within the packaging contains latex, despite the products being labelled as latex-free. Stryker states latex could potentially cause an allergic reaction.
The recall covers 39,148 units, including GTIN 00816744028244 for NN-8024, across lots including 37AI2944, 37AJ2013, 37BD3753 and 37BD3778. Distribution was worldwide, including nationwide in the United States and to Australia, Belgium, Canada, England, Ireland and Italy. The FDA has classified the action as Class II.
A latex-free label is exactly what a latex-allergic patient or clinician relies on. The enforcement record reports no injuries. Facilities should quarantine affected lots and follow Stryker's instructions.
The recalled product
- 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;
- Manufacturer
- Stryker Corporation
- Affected units
- 39,148
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- NN-8026 00816744028268 37BJ1837 37CC7852 37CH0643 37DJ1056
- NN-8042 07613327663280 37CC9220 37ED9408 37FJ2202 37II2308 37LD8666
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Stryker Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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