FDA Device recall Z-0599-2026
NICO Myriad Handpiece Product Number/Product Name: NN-8000 15x10 MHP
- FDA Device
- Class II
- ongoing
- Published 2025-12-03
On 2025-12-03 the FDA classified a Class II recall of NICO Myriad Handpiece Product Number/Product Name: NN-8000 15x10 MHP by Stryker, citing tape used to secure components within packaging contains latex, despite products being labeled as latex-free. Latex could potentially cause an allergic reaction.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0599-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-10-31 |
| Published | 2025-12-03 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Stryker |
| Distribution | US |
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
Tape used to secure components within packaging contains latex, despite products being labeled as latex-free. Latex could potentially cause an allergic reaction.
Identifiers
| code_info | Product Number/UDI-DI (GTIN)/Lot Numbers: NN-8000 00816744028008 37BH1415 37CB3768 37DC0517 37EB6074 37GA4892 37GB792…Product Number/UDI-DI (GTIN)/Lot Numbers: NN-8000 00816744028008 37BH1415 37CB3768 37DC0517 37EB6074 37GA4892 37GB7928 37JI2310 37JJ0604 37KB3653 37KI1915 37LA0162; NN-8001 00816744028015 37BC7385 37DJ1035 37EB5920 37EB6075 37ED9464 37FC3028 37GD1188 37HB0020 37HD3586 37ID3702 37JA8380 37JD5540 37JI2312 37KH3023 37KI1916 37LC1191 37LI1727; NN-8002 00816744028022 37AC5372 37AC5631 37AE1273 37AH1830 37BA1102 37BB2319 37BC7386 37BD3731 37BJ1508 37CB4081 37CD5349 37CD5637 37DA1503 37DA9507 37DC0519 37DH3011 37DI2303 37DJ1036 37EC1900 37ED8566 37ED9571 37EE5791 37FC3030 37FI2611 37FJ2203 37GA4306 37GA5370 37GC4834 37GI1763 37GJ1619 37HB9007 37HD2741 37HH0317 37HI1617 37HJ1814 37IA7295 37ID4143 37ID5031 37II1827 37IJ0319 37JB1412 37JD5541 37JI2101 37KD7643 37KG1725 37KH0104 37KH3004 37KJ0706 37LA0163 37LA0680 37LC1192 37LD8928 37LG1840 37LI1731 37LJ0817; NN-8003 00816744028039 37AJ2009 37BC7387 37BH1419 37BJ1509 37CD5353 37DC0522 37EB5596 37EB5984 37ED8570 37EI2141 37FA3637 37FB6706 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0599-2026%22
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