Z-0600-2026Class II

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

Name: Z-0600-2026 NICO Myriad Illumination Pack Product No. NN-1000 11g Illumination Sleeve/Fiber; Product No. NN-1001 13g...
Creator: Stryker Corporation
Published: 2025-10-31
License: https://open.fda.gov/license/

Stryker Corp. / initiated 2025-10-31 / Open, Classified / root cause: labeling and UDI

FDA source

Stryker Corporation began a recall of NICO Myriad Illumination Pack Product No. NN-1000 11g Illumination Sleeve/Fiber; Product No. NN-1001 13g Illumination Sleeve/Fiber on 2025-10-31. FDA classified it as Class II and gives the reason as "Tape used to secure components within packaging contains latex, despite products being labeled as latex-free. Latex could potentially cause an allergic reaction". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0600-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-10-31
Posted: 2025-11-26
Recalling firm: Stryker Corp.
Product: NICO Myriad Illumination Pack Product No. NN-1000 11g Illumination Sleeve/Fiber; Product No. NN-1001 13g Illumination Sleeve/Fiber
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
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.
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: On October 31, 2025, the firm began notifying impacted customers through Urgent Medical Device Recall letters. Customers were instructed to mark affected product with "CONTAINS LATEX" and place a copy of the notice at the product's storage location before use. Product returns are not required. However, customers who would like to receive a replacement were given options to destroy or return product for a replacement.
Quantity in commerce: 39,148
Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Belgium, Canada, England, Ireland, Italy, Kuwait, Singapore, Slovenia, Spain, and the Netherlands.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0600-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0599-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-12-03	2025-11-26
Z-0600-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-12-03	2025-11-26
Z-0601-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-12-03	2025-11-26

Product code GEI

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)