Class II U.S. Food and Drug Administration

Stryker Corporation NICO BrainPath recall: Tape used to secure components within packaging contains latex

Recall published 11 months ago

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

The hazard: Device safety concern

A device recall was filed for this product. For anything implanted or relied on daily, the clinician comes before the paperwork.

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

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Recall number
Z-0601-2026
Published
December 3, 2025
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Stryker Corporation
Product type
Medical devices
Units affected
39,148
Distribution
Nationwide
Made in
United States
Lot / code info
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
UPC codes
00816744028244, 00816744028251, 00816744028268, 07613327663280

Products covered by this recall

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;

Check your product

The notice names 5 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 00816744028244
  • 00816744028251
  • 00816744028268
  • 07613327663280

Model or item number

On the rating label, the box or the instruction sheet.

  • UDI-DI

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Device

Stryker Corporation — A device recall was filed for this product. For anything implanted or relied on daily, the clinician comes before the paperwork.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. Ask the supplier or clinic that provided it what the remedy is in your case.
  3. If you are a facility, quarantine affected stock and log the correction.
  4. Report device problems to the FDA through MedWatch.

Claiming on a recalled device

Device recalls are tracked by serial and lot number, so your claim moves faster if you lead with those.

  • Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.
  • Ask explicitly whether your unit is in the affected range; many recalls cover only part of a model line.
  • If you need the device daily, ask what interim arrangement they offer while the remedy is carried out.
  • Log the date, the name and the reference number of every call. Device recalls can run for months.

Company contact: Stryker Corporation — 1941 Stryker Way, Portage, MI, 49002-9711

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Stryker Corporation medical devices recalled?

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

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 00816744028244, 00816744028251, 00816744028268; model number UDI-DI. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.

Where was the recalled product sold?

It was distributed nationwide.

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