Recall Z-0599-2026 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Stryker Corporation
NICO Myriad Handpiece Product Number/Product Name: NN-8000 15x10 MHP; NN-8001 15x 13 MHP; NN-8002 15x 25 MHP - MINOP; NN-8003 13x10 MHP; NN-8004 13x13 MHP; NN-8005 15x25 MHP GAAB; NN-8006 11X10 MHP; NN-8007 11x13 MHP; NN-8008 19x28 MHP OI; NN-8010 17x31.5 MHP DECQ; NN-8015 NICO Fluid System (NFS); NN-8017 11x13 MHP/PB; NN-8018 13X13 MHP/PB; NN-8019 19x28 MHP Little LOTTA; NN-8020 19x21.5 MHP Pa
| Date | Nov 26, 2025 (initiated Oct 31, 2025) |
| Status | Open, Classified |
| Reason | 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 | 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 | 39,148 |
| Distribution | Worldwide distribution - US Nationwide and the countries of Australia, Belgium, Canada, England, Ireland, Italy, Kuwait, Singapore, Slovenia, Spain, and the Netherlands. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K191599 | NICO Myriad NOVUS Nico Corporation, Sep 13, 2019 |