NICO Myriad Handpiece Product Number/Product Name: NN-8000 15x10 MHP — Class II medical device recall Z-0599-2026
Ongoing recall by Stryker Corporation, reported 2025-12-03, distributed nationwide. Tape used to secure components within packaging contains latex, despite products being labeled as latex-free.
| Recall number | Z-0599-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stryker Corporation, Portage, MI, United States |
| Recall initiated | 2025-10-31 |
| Classified | 2025-11-26 |
| Reported by FDA | 2025-12-03 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BE, CA, ES, GB, IE, IT, KW, NL, SG, SI |
| Quantity | 39,148 |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00816744025007, 00816744025014, 00816744025021, 00816744025038, 00816744025045, 00816744025052, 00816744025069, 00816744025076, 00816744025083, 00816744025106, 00816744025175, 00816744025182, 00816744025199, 00816744025205, 00816744025212, 00816744028008, 00816744028015, 00816744028022, 00816744028039, 00816744028046, 00816744028053, 00816744028060, 00816744028077, 00816744028084, 00816744028107 and 6 more |
| Lot numbers | 15X10MHP, 15X13MHP, 15X25, 19X21.5, 19X21.5MHP, 37AA0522, 37AA0524, 37AA0526, 37AB1587, 37AB1597, 37AB1601, 37AC4878, 37AC5372, 37AC5387, 37AC5388, 37AC5392, 37AC5393, 37AC5631, 37AC5632, 37AC5634, 37AC5635, 37AC5636, 37AC5637, 37AC5646, 37AD2692, 37AE0103, 37AE1273, 37AE1285, 37AE9793, 37AE9800, 37AE9804, 37AH0600, 37AH1036, 37AH1052, 37AH1741, 37AH1825, 37AH1829, 37AH1830, 37AI2352, 37AI2353 and 460 more |
Product
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 PaediScope; NN-8021 15x26.5 MHP LOTTA; NN-8500 15x10 MHP; NN-8501 15x13 MHP; NN-8502 15x25 MINOP MHP; NN-8503 13x10 MHP; NN-8504 13x13 MHP; NN-8505 15x25 GAAB MHP; NN-8506 11X10 MHP; NN-8507 11x13 MHP; NN-8508 19x28 OI MHP; NN-8510 17x31.5 DECQ MHP; NN-8517 13X13 MHP/PB; NN-8518 11x13 MHP/PB; NN-8519 19x28 Little LOTTA MHP; NN-8520 19x21.5 PaediScope MHP; NN-8521 15X26.5 LOTTA MHP;
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0599-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.