NICO Myriad Handpiece Product Number/Product Name: NN-8000 15x10 MHP
Medical device recall Z-0599-2026. Published in FDA’s Enforcement Report on Dec 3, 2025.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Dec 3, 2025. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 39,148 how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
Tape used to secure components within packaging contains latex, despite products being labeled as latex-free. Latex could potentially cause an allergic reaction.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
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;
39,148, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
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…
Every code shown here, 1,994 characters
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…
FDA’s list runs to 6,472 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Worldwide distribution - US Nationwide and the countries of Australia, Belgium, Canada, England, Ireland, Italy, Kuwait, Singapore, Slovenia, Spain, and the Netherlands.
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Oct 31, 2025.
- FDA classified it on Nov 26, 2025.
- FDA’s Enforcement Report published it on Dec 3, 2025.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Stryker Corporation, of Portage, MI.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 6,472 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.