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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Surgical Equipment

Stryker NICO Myriad and BrainPath Devices Recalled for Undeclared Latex

Agency Publication Date: November 26, 2025
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Summary

Stryker Corporation is recalling approximately 39,148 surgical devices because the tape used to secure components within the packaging contains latex, even though the products are labeled as latex-free. The recall includes various NICO Myriad Handpieces, Illumination Packs, and BrainPath Shepherd's Hook tools. While the products themselves may be safe, the presence of latex in the packaging poses a risk to patients or medical staff with latex sensitivities. Stryker has initiated this voluntary recall to correct the misleading labeling and prevent potential allergic reactions.

Risk

Exposure to undeclared latex in medical packaging can cause allergic reactions in individuals with latex sensitivities. These reactions can range from skin irritation and hives to more severe symptoms, including respiratory distress or anaphylaxis.

What You Should Do

  1. This recall affects Stryker NICO Myriad Handpieces, Myriad Illumination Packs, and BrainPath devices where the packaging tape contains latex despite being labeled latex-free.
  2. Identify affected products by checking the model number (such as NN-1000, NN-8000, or NN-8521) and the lot number printed on the device packaging. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled devices immediately and quarantine any remaining inventory.
  4. Contact Stryker Corporation or your medical distributor to arrange for the return, replacement, or correction of these products.
  5. Medical professionals and facilities should contact Stryker Corporation for further instructions regarding the disposition of affected stock.
  6. Call the FDA Consumer Complaint hotline at 1-888-463-6332 or visit www.fda.gov/medical-device-recalls for more information.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: NICO Myriad Handpiece
Variants: 15x10 MHP, 15x 13 MHP, 15x 25 MHP - MINOP, 13x10 MHP, 13x13 MHP, 15x25 MHP GAAB, 11X10 MHP, 11x13 MHP, 19x28 MHP OI, 17x31.5 MHP DECQ, NICO Fluid System (NFS), 11x13 MHP/PB, 13X13 MHP/PB, 19x28 MHP Little LOTTA, 19x21.5 MHP PaediScope, 15x26.5 MHP LOTTA, 15x25 MINOP MHP, 15x25 GAAB MHP, 19x28 OI MHP, 17x31.5 DECQ MHP, 19x28 Little LOTTA MHP, 19x21.5 PaediScope MHP, 15X26.5 LOTTA MHP
Model / REF:
NN-8000
NN-8001
NN-8002
NN-8003
NN-8004
NN-8005
NN-8006
NN-8007
NN-8008
NN-8010
NN-8015
NN-8017
NN-8018
NN-8019
NN-8020
NN-8021
NN-8500
NN-8501
NN-8502
NN-8503
NN-8504
NN-8505
NN-8506
NN-8507
NN-8508
NN-8510
NN-8517
NN-8518
NN-8519
NN-8520
NN-8521
Lot Numbers (632):
37BH1415
37CB3768
37DC0517
37EB6074
37GA4892
37GB7928
37JI2310
37JJ0604
37KB3653
37KI1915
37LA0162
37BC7385
37DJ1035
37EB5920
37EB6075
37ED9464
37FC3028
37GD1188
37HB0020
37HD3586
37ID3702
37JA8380
37JD5540
37JI2312
37KH3023
37KI1916
37LC1191
37LI1727
37AC5372
37AC5631
37AE1273
37AH1830
37BA1102
37BB2319
37BC7386
37BD3731
37BJ1508
37CB4081
37CD5349
37CD5637
37DA1503
37DA9507
37DC0519
37DH3011
37DI2303
37DJ1036
37EC1900
37ED8566
37ED9571
37EE5791
UDI:
00816744028008
00816744028015
00816744028022
00816744028039
00816744028046
00816744028053
00816744028060
00816744028077
00816744028084
00816744028107
00816744028152
00816744028176
00816744028183
00816744028190
00816744028206
00816744028213
00816744025007
00816744025014
00816744025021
00816744025038
00816744025045
00816744025052
00816744025069
00816744025076
00816744025083
00816744025106
00816744025175
00816744025182
00816744025199
00816744025205
00816744025212
Product: NICO Myriad Illumination Pack
Variants: 11g Illumination Sleeve/Fiber, 13g Illumination Sleeve/Fiber
Model / REF:
NN-1000
NN-1001
Lot Numbers:
37AC5163
37AE9811
37AJ1438
37BJ0513
37CB3410
37CB3416
37CD6003
37CE3030
37EB5720
37FA4260
37GD2216
37GJ1603
37IC7023
37IJ0208
37JJ0122
37KI1300
37LA0158
37LI0320
37LJ1522
37AC5177
37AE9942
37AE9955
37AJ1439
37BJ0516
37CB3380
37CB3419
37CD6005
37CJ0204
37DE4864
37EB5721
37FA4261
37GD2219
37GJ1607
37IC7027
37IJ0209
37JD5753
37JJ0123
37KI1301
37LA0159
37LI0322
37LJ1525
UDI:
00816744021009
00816744021016
Product: NICO BrainPath Shepherd's Hook
Variants: Greenberg, Sugita, Budde, Greenberg LK
Model / REF:
NN-8024
NN-8025
NN-8026
NN-8042
Lot Numbers:
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
37BB2326
37BJ1836
37CH0640
37DC0545
37HD2766
37KB3677
37KJ1139
37BJ1837
37CC7852
37CH0643
37DJ1056
37CC9220
37ED9408
37FJ2202
37II2308
37LD8666
UDI:
00816744028244
00816744028251
00816744028268
07613327663280

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97833
Status: Active
Manufacturer: Stryker Corporation
Sold By: Hospitals; Surgical Centers; Medical Supply Distributors
Manufactured In: United States
Units Affected: 3 products (39,148)
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

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This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.