CLASS II ONGOING Device recall · Reported 3 Dec 2025 · FDA Enforcement Report

NICO Myriad Illumination Pack Product No. NN recalled by Stryker

Stryker is recalling NICO Myriad Illumination Pack Product No. NN-1000 Illumination Sleeve/Fiber, distributed nationwide in the US. The recall was initiated on 31 Oct 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesProduct Number/UDI-DI (GTIN)/Lot Numbers: NN-1000 00816744021009 37AC5163 37AE9811 37AJ1438 37BJ0513 37CB3410 37CB3416 37CD6003 37CE3030 37EB5720 37FA4260 37GD2216 37GJ1603 37IC7023 37IJ0208 37JJ0122 37KI1300 37LA0158 37LI0320 37LJ1522; NN-1001 00816744021016 37AC5177 37AE9942 37AE9955 37AJ1439 37BJ0516 37CB3380 37CB3419 37CD6005 37CJ0204 37DE4864 37EB5721 37FA4261 37GD2219 37GJ1607 37IC7027 37IJ0209 37JD5753 37JJ0123 37KI1301 37LA0159 37LI0322 37LJ1525

Quantity recalled39,148

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0600-2026
FDA event ID: 97833
Recalling firm: Stryker, Portage, MI
Classification: Class II
Status: Ongoing
Recall initiated: 31 Oct 2025
FDA classified: 26 Nov 2025
Reported: 3 Dec 2025
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Other Medical Devices

Timeline

31 Oct 2025	Recall initiated by company
26 Nov 2025	Classified by FDA	+26 days
3 Dec 2025	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

NICO Myriad Illumination Pack Product No. NN-1000 11g Illumination Sleeve/Fiber; Product No. NN-1001 13g Illumination Sleeve/Fiber

Where it was distributed

Worldwide distribution - US Nationwide and the countries of Australia, Belgium, Canada, England, Ireland, Italy, Kuwait, Singapore, Slovenia, Spain, and the Netherlands.

Nationwide

Questions about this recall

Why was it recalled?

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

Which lots are affected?

Product Number/UDI-DI (GTIN)/Lot Numbers: NN-1000 00816744021009 37AC5163 37AE9811 37AJ1438 37BJ0513 37CB3410 37CB3416 37CD6003 37CE3030 37EB5720 37FA4260 37GD2216 37GJ1603 37IC7023 37IJ0208 37JJ0122 37KI1300 37LA0158 37LI0320 37LJ1522; NN-1001 00816744021016 37AC5177 37AE9942 37AE9955 37AJ1439 37BJ0516 37CB3380 37CB3419 37CD6005 37CJ0204 37DE4864 37EB5721 37FA4261 37GD2219 37GJ1607 37IC7027 37IJ0209 37JD5753 37JJ0123 37KI1301 37LA0159 37LI0322 37LJ1525

Where was it sold?

Worldwide distribution - US Nationwide and the countries of Australia, Belgium, Canada, England, Ireland, Italy, Kuwait, Singapore, Slovenia, Spain, and the Netherlands.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

2 other products · FDA event 97833

This product is part of a recall event; the main page for the event is NICO BrainPath recalled by Stryker.

Reported	Class	Recall	Company	Reason	Where
3 Dec 2025	CLASS II	NICO BrainPath recalled by Stryker	Stryker	Packaging Defects	Nationwide
3 Dec 2025	CLASS II	NN-8000 MHP recalled by Stryker	Stryker	Packaging Defects	Nationwide

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