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U.S. Department of Health and Human Services

Class 2 Device Recall NICO Myriad

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 Class 2 Device Recall NICO Myriadsee related information
Date Initiated by FirmOctober 31, 2025
Date PostedNovember 26, 2025
Recall Status1 Open3, Classified
Recall NumberZ-0599-2026
Recall Event ID 97833
510(K)NumberK191599 
Product Classification Electrosurgical, cutting & coagulation & accessories - Product Code GEI
ProductNICO 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;
Code Information 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 37FC3037 37FD0078 37GJ1620 37HB0021 37HH0314 37IB0874 37ID5058 37IG2927 37II1824 37JA8394 37JG1103 37JH0115 37JI2102 37KB3657 37KD7651 37KI1917 37LC1674 37LH1805 37LI1733; NN-8004 00816744028046 37AA0522 37AC5387 37AC5632 37AE9800 37AH1052 37AH1741 37AI2352 37AJ2011 37BA0230 37BB2320 37BC7388 37BD3754 37BH1422 37BI1926 37CA0227 37CB4082 37CD5553 37CD5638 37CH0723 37CJ2211 37DA2200 37DA9508 37DB4672 37DC0524 37DC9362 37DH0251 37DH3014 37DI2304 37DJ1037 37EA2247 37EB5985 37EC1901 37ED8572 37EI2145 37EJ2022 37FA3639 37FD0084 37FH0606 37FI2612 37FJ2205 37GA4308 37GA5371 37GC4336 37GC4835 37GD1193 37GI1764 37GJ1622 37HA6682 37HB0022 37HB9008 37HD2742 37HH0313 37HH2305 37HI1618 37HJ1815 37IA7297 37IB0875 37IB0876 37IC6867 37ID4150 37ID5059 37II1833 37JA8395 37JC8278 37JD5597 37JG0201 37JG1107 37JH0116 37JI2103 37KB3658 37KB3731 37KC9435 37KD7675 37KH0161 37KH3005 37KJ0506 37LA0164 37LA0703 37LC1194 37LC1675 37LD8936 37LH1809; NN-8005 00816744028053 37BI1922 37FI2613 37HA6683 37HJ1100 37IB0877 37II1835 37LJ0818; NN-8006 00816744028060 37AC5388 37DB4673 37DC9363 37EA2818 37EC1903 37ED8458 37EI2146 37FD9828 37FI2614 37GB7926 37HI1621 37IC6868 37ID4154 37IJ0320 37JB1404 37JG0203 37KI1918 37LA0166 37LD8946; NN-8007 00816744028077 37AB1587 37AC5634 37AH1825 37AI2353 37AJ2012 37BA0231 37BB2321 37BC7389 37BD3756 37BI1924 37BJ1828 37CA1600 37CD5554 37CD5641 37CI1910 37CJ2212 37DA9509 37DB4676 37DC9509 37DH0253 37DH3009 37DI2305 37DJ1038 37EA0600 37EA2723 37EA2820 37EB5994 37EC1904 37EI2149 37EJ2024 37FA3651 37FH0608 37FI2615 37FJ2206 37GA4309 37GA5372 37GC4839 37GD1198 37GI1765 37HA6691 37HD2750 37HH0318 37HH2308 37IA7299 37IB0878 37IC6871 37ID5090 37ID5092 37JA8457 37JC8279 37JD5598 37JG0205 37JH0117 37JI2104 37JJ0513 37KB3664 37KC9467 37KD7677 37KH0165 37KH3009 37KI1919 37LD8949 37LG1837 37LH1810 37LI1800 37LJ0819; NN-8008 00816744028084 37AB1597 37AJ3013 37BJ1829 37CA0230 37CJ2213 37DJ1039 37FI2616 37GA4310 37GC4841 37HB9009 37IA7302 37IC6875 37JB1405 37JG0207 37JJ0605 37KG1418 37KG1510 37LI1804 75HG2942 75KI2015; NN-8010 00816744028107 37BJ1834 37DH0303 37DJ1040 37FA3669 37IJ1015 37LA0704 37LC1195; NN-8015 00816744028152 37AE9793 37BD3764 37DA1557 37DA1558 37DC9510 37EA2474 37EB5685 37FC3045 37GA4316 37GD1216 37ID5098 37JA8398 37JB1410 37JB1411 37KB3726; NN-8017 00816744028176 37AC5635 37AE0103 37AI2354 37BD3759 37BH1426 37BI1930 37CB4085 37CD5642 37CH0720 37CI1911 37DA2001 37DC0534 37DH0306 37DH3004 37DI2306 37DJ1041 37EB5686 37EB5997 37ED8576 37EE5825 37EI2156 37EJ2026 37FA2828 37FD0144 37FH0611 37FI2617 37FJ2207 37GC4847 37GI1767 37HA6692 37HB0024 37HH0321 37HH2317 37HJ1816 37ID4155 37II1841 37JG0208 37JG1105 37JH0122 37JJ0608 37KB3666 37KG2107 37KH3020 37LA0705 37LC1200 37LD8950 37LG1845 37LH1811 37LI1805 75JG0514; NN-8018 00816744028183 37AA0524 37BC7397 37BE1491 37EB6000 37HA6697 37HD2753 37HH0320 37IB0880 37LA0170 37LD8952; NN-8019 00816744028190 37AB1601 37AC5636 37AE1285 37AE9804 37AH1036 37BA0232 37BD3760 37BJ1830 37CD5557 37DA2202 37DB4677 37DC0535 37DC9514 37DI2633 37DJ1042 37ED8577 37EI2140 37FC3055 37FH0602 37FI2609 37GC4851 37GD1223 37GI1768 37HB9026 37HD2754 37HJ1817 37ID5100 37JB1422 37JI0713 37KB3674 37KC9470 37KD7723 37KG1416 37KH0163 37LC1210 37LC1681 37LJ1527 75HG2936 75HG2937 75HG2940 75HG2941; NN-8020 00816744028206 37BC7399 37CD5558 37EC1905 37EI2139 37EJ2027 37FC3092 37GI1769 37HB0025 37HH0322 37HI0130 37IA7303 37LI1807; NN-8021 00816744028213 37AA0526 37AC5637 37AD2692 37BA0400 37BB2322 37BH1429 37BJ1831 37CA0232 37CB4087 37CD5559 37CD5644 37CE2596 37CH0715 37CI1909 37CI1912 37DA2239 37DA9512 37DC0536 37DD8119 37DH3012 37DI2623 37DJ1043 37EB6002 37EC0830 37EC1908 37ED8582 37EE6617 37EI2160 37EJ2028 37FB6637 37FC3093 37FD0150 37FH0613 37FI2618 37GA4345 37GC4852 37GD1447 37GI1772 37HB0028 37HB9027 37HD2765 37HI1623 37HJ1101 37HJ1818 37ID4158 37ID5104 37II1843 37IJ1005 37JD5600 37JD5782 37JH0125 37JI2165 37JJ0609 37KB3675 37KC9471 37KG1412 37KH0162 37KH3022 37LA0707 37LC1683 37LD8956 37LI1809 37LJ1528; NN-8500 00816744025007 37AC5392 37DC9515 37DJ1044 37HI1634 37IJ1007 37KI1920; NN-8501 00816744025014 37CC7849 37DC9516 37DI2627 37DJ1045 37FD0155 37HI1638 37JA8443 37KI1921; NN-8502 00816744025021 37BA1106 37CD5646 37DI2628 37DJ1046 37GD1474 37HC4974 37HI1639 37HJ1102 37IA7304 37JB1455 37KB3678 37KB3706 37KD6865 37LA0710 37LI1810; NN-8503 00816744025038 37AC5393 37BE1488 37BE1638 37CJ2214 37ED9004 37FC3095 37GD2039 37GI1773 37IJ1008 37KD6867 37LI1811; NN-8504 00816744025045 37AC5646 37AH0600 37AH1829 37AJ2015 37BE1489 37CA0233 37CB4111 37CH0724 37DA9514 37EB6004 37EE6465 37EJ2031 37GA5374 37GE8331 37HH0315 37HI1641 37IA7306 37IH2628 37KD6878 37LA0729 37LH1812 75AH0216; NN-8505 00816744025052 37AC4878 37DI2629 37DJ1048 37HJ1103 37IA7312; NN-8506 00816744025069 37CI1836 37DJ1049 37GA4513 37IJ1009 37JH2433 37KB3681 37LH1813 37LI1814; NN-8507 00816744025076 37BA0401 37BB2328 37BJ1838 37CI1916 37DJ1051 37GI1778 37IJ1010 37JB1456 37JG0214 37LA0174; NN-8508 00816744025083 37CI1917 37CJ2215 37HB9031 37IC6878 37JJ0610; NN-8510 00816744025106 37BJ1835 37CB4112 37FC3097 75KI2225; NN-8517 00816744025175 37AI2946 37CB4118 37DA2701 37EH2906 37GA5375 37GC4337 37HH2903 37JB1457 37KH2955; NN-8518 00816744025182 37GA4637 37HB9032 37KJ1717 37LJ1532; NN-8519 00816744025199 37BC7418 37FD0159 37HC4981 37JI1556 37LC1691; NN-8520 00816744025205 37CC7851 37HD2770 37IC6879; NN-8521 00816744025212 37BJ1260 37BJ1832 37CB4144 37CD5653 37DA9528 37HC4984 37HD2772 37HJ1104 37JI1820 37JJ0611 37LC1231
Recalling Firm/
Manufacturer		 Stryker Corporation
1941 Stryker Way
Portage MI 49002-9711
For Additional Information ContactBrooke Thompson
269-800-1941
Manufacturer 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.
FDA Determined
Cause 2		Under Investigation by firm
ActionOn 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 Commerce39,148
DistributionWorldwide distribution - US Nationwide and the countries of Australia, Belgium, Canada, England, Ireland, Italy, Kuwait, Singapore, Slovenia, Spain, and the Netherlands.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = GEI
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