Z-3210-2018Class II

Endoscopic Cleaning Brush, single use, sold in kits and labeled as the following: a. Item Number DYK1002DCB...

Name: Z-3210-2018 Endoscopic Cleaning Brush, single use, sold in kits and labeled as the following: a. Item Number DYK1002DCB...
Creator: Medline Industries Inc
Published: 2018-06-15
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2018-06-15 / Terminated

FDA source

Medline Industries Inc began a recall of Endoscopic Cleaning Brush, single use, sold in kits and labeled as the following: a. Item Number DYK1002DCB, BRUSH, CLEANING, DOUBLE ENDED, W/ HANDLE - 300... on 2018-06-15. FDA classified it as Class II and gives the reason as "There is potential risk of brush detachment during cleaning. If brush detachment is not identified, there is the potential for the brush to be left within the scope". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-3210-2018
Classification: Class II
Status: Terminated
Initiated: 2018-06-15
Posted: 2018-10-11
Terminated: 2020-05-18
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Product: Endoscopic Cleaning Brush, single use, sold in kits and labeled as the following: a. Item Number DYK1002DCB, BRUSH, CLEANING, DOUBLE ENDED, W/ HANDLE - 300 EA/CS, 50EA/BX, 6BX/CS; b. Item Number DYK1002DBDE, BRUSH, CLEANING, DBL, DIF ENDS - 500 EA/CS, 50 EA/BX, 10 BX/CS; c. Item Number DYK1002DBSE, BRUSH, CLEANING, DBL, SAME END - 500 EA/CS, 50 EA/BX, 10 BX/CS; d. Item Number DYK1002SBC, BRUSH, CLEANING, SINGLE END - 500 EA/CS, 50 EA/BX, 10 BX/CS
Product code: MNL Accessories, Cleaning Brushes, For Endoscope
Reason for recall: There is potential risk of brush detachment during cleaning. If brush detachment is not identified, there is the potential for the brush to be left within the scope.
FDA root cause: Under Investigation by firm
Action: Medline notified customers on about 06/15/2018 via URGENT RECALL MEDLINE INDUSTRIES, INC. IMMEDIATE ACTION REQUIRED letter. Accounts that purchased a custom kit or standard Pack were instructed to immediately check inventory for affected devices, quarantine any affected devices, affix the provided stickers on affected kits and continue use but were instructed to not use the Endoscopic Cleaning Brush in the kit and to instead pull another approved product from inventory. They were also instructed to complete and return the Verification Form. Accounts that just purchased the Endoscopic Cleaning Brush were instructed to immediately check inventory for affected devices, destroy any affected devices, notify customers if the product has been further distributed, and complete and return the provided destruction form listing the quantity of affected products destroyed or that there was no product on hand to destroy.
Quantity in commerce: 183,606 devices total
Distribution: Nationwide distribution to AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NH, NJ, NM, NV, NY, OH, OK, PA, RI, SC, TN, TX, VA, VT, WA, WI, WV, WY
Product codes and lots: Endoscopic cleaning brush finished good lot numbers: GM10, GJ25, HA05, HA20. Kits: a. Item Number DYK1002DCB, kit Number (Kit Lot Number): DYK1001DCB (18BA0735), DYK1002144B (18BA0644, 18DA0124), DYK1008972E (18BA2199, 18DA1418, 18EAA023, 18EAA653), DYK1012268E1 (18BA1667, 18CA0872, 18CA1289, 18DA1732), DYK1012414E1 (18CA0793, 18CA1644, 18DA0413), DYK1017922E (18CA1300), DYK1018542E (18CA0622, 18DA1159, 18EAB507), DYK1044978E (18EBE085, 18NB1289), DYK1067817E1 (18AA1969, 18EAA004, 18EAB365), DYK1072097E (18DA0437, 18EAA790), DYK1097615E (18CA0687, 18EAA084), DYK1177017E (18BA2352, 18DA1481), DYK1188722E (18EAA016, 18EAB529), DYK1253578E (18AA2092, 18DA0331), DYK1253578F (18DA1595), DYK1266757E (18BA0203, 18DA0062, 18DF0085), DYKE1003A (18DA1488, 18FAA025), DYKE1011B (18AA1276), DYKE1012C (18DA0090, 18EAA521), DYKE1013 (18CB4388, 18EBL745), DYKE1014B (17KA1195, 18AA0984, 18CA0691, 18CA1969, 18DA0344, 18DA1167), DYKE1022A (18EBE830), DYKE1029C (18BA0279, 18CA0842), DYKE1032C (18BB1877, 18BB6935, 18EBH874, 18EBS890, 18OB9988), DYKE1033B (18MB9361), DYKE1033C (18CB1145, 18DB0018, 18EBH875), DYKE1037 (18CA1072, 18DA0377), DYKE1043C (18DA0411, 18EAA198), DYKE1048 (18BA0550), DYKE1050 (18BA0830, 18CA1744, 18EAA936), DYKE1056C (18DA0952, 18EBF206, 18EBF513, 18EBN896, 18PB3439), DYKE1058A (18BB6939, 18CB5355, 18PB4193), DYKE1059A (18BB582118EBF514), DYKE1062A (18CA1504), DYKE1062B (18EAB341), DYKE1063 (18BB4018, 18EBL836, 18OB2537, 18PB6224), DYKE1064 (18BB2161, 18DB8246, 18EBL833), DYKE1069A (18CA0564, 18CA1222), DYKE1069B (18DA0510), DYKE1072 (18BA0524, 18DA0412, 18EAA070), DYKE1077 (18BA1594, 18DA0096, 18EAB672), DYKE1096A (18BA1239, 18DA0345, 18FAA190), DYKE1099 (18BA1707), DYKE1108C (17JA2124, 17KA1225), DYKE1108D (18AA2499, 18BA1296, 18CA0336), DYKE1112 (18CA0139), DYKE1120 (18BA2330, 18DA0523, 18EAB011), DYKE1123 (18CA0181, 18DA0779, 18EAB549), DYKE1126A (18BA0589, 18CA1597), DYKE1138A (18BA1559, 18CA2056), DYKE1143A (18BA0473), DYKE1152 (18DA1187, 18EAA714), DYKE1158A (18BA2208, 18EAA253, 18EAB695, 18FAA253), DYKE1159A (18FAA227), DYKE1161A (18BA1435, 18EAB349), DYKE1162G (17JA2795), DYKE1162I (18AA1616, 18AA2211, 18BA0354), DYKE1162J (18BA1753, 18DA1469), DYKE1164 (18EBD023, 18OB2534), DYKE1172C (18EAA129), DYKE1176 (18CA1092, 18DA1719), DYKE1184B (17IA1038, 17JA1424, 17LA1730, 18BA1937, 18DA1028), DYKE1185 (18CA1513), DYKE1203A (18DA0680, 18FAA307), DYKE1207 (18BA1174, 18CA0313, 18EAA076, 18EAA397), DYKE1224C (18DA0018, 18EAA709), DYKE1232 (18CA0337, 18EAA730), DYKE1233 (18AA1392, 18BA0937, 18DA0390, 18DB7237, 18EBG997, 18EBT332), DYKE1234 (18FAA404), DYKE1245 (18BA0307, 18BA0908), DYKE1249 (18BA1440, 18DA1612, 18FAA258), DYKE1250 (18BA2009, 18EAA141), DYKE1258 (18BA1480, 18EAA325), DYKE1265 (18DA0068, 18DA0206, 18EAB322, 18EAB747), DYKE1274A (18CA0987, 18EAB342), DYKE1293 (18BA0492, 18CA1224, 18DA1377, 18EAB042), DYKE1295 (18BA0770, 18CA1963, 18DA1479), DYKE1303 (18MB9887, 18OB2532), DYKE1304 (18BB5870, 18DB7236), DYKE1308 (18CA0292, 18DA0841), DYKE1313B (18CA1559, 18EAB036), DYKE1314A (18CA1327), DYKE1318 (18BA0888, 18DA1352, 18FAA368), DYKE1332A (18EAA061), DYKE1333 (18BA0763, 18EAA432), DYKE1334B (18BA0597, 18EAA447), DYKE1345 (18CA1207, 18DA1486), DYKE1350A (18BB2129, 18DB7371, 18EBO982), DYKE1357B (18CA0267), DYKE1357C (18DA1208, 18FAA100), DYKE1364A (17LA1129, 18BA0029, 18DB7239, 18EBD050), DYKE1366 (18BA0796, 18CA1707, 18EAB410), DYKE1369C (17JA2209, 17LA2210, 18BA0882, 18CA1422), DYKE1372 (18NB4423), DYKE1375A (18BA1778, 18CA2032), DYKE1385 (18BA0562, 18CA1193, 18EAA304), DYKE1386 (18CA0393, 18DA0589, 18FAA222), DYKE1391 (18EAB593), DYKE1393A (18BA0591, 18CA1406, 18DA0833, 18EAA789), DYKE1395A (18CA0886, 18DA0717, 18FAA293), DYKE1399 (18DA0204, 18EAA422, 18FAA144), DYKE1402 (18BB5817, 18DB7373, 18EBS803), DYKE1406 (18CA0328, 18DA0091), DYKE1409 (18DA0216, 18EAB769), DYKE1410 (18BA0708, 18CA0837, 18DA1564, 18EAA453), DYKE1415 (18CA1723, 18DA1887, 18EAB265), DYKE1416 (18DA1072, 18EAA886), DYKE1422A (18BA1978, 18DA1468), DYKE1423A (18CA1662, 18DA1174, 18EAA686), DYKE1431B (18BA0503, 18DA1586, 18EAA301, 18EAB901), DYKE1438A (18AA1176), DYKE1438B (18CA0630, 18EAB038), DYKE1441B (18DA1320, 18DA1745, 18EAB829), DYKE1442A (18DB7372, 18NB2540), DYKE1448 (18BA1463, 18CA1544), DYKE1455 (18CA0109, 18EAA273, 18EAB548), DYKE1456 (18BA0145, 18CA0268, 18DA0642, 18EAA706), DYKE1457 (18BA0626, 18EAA078), DYKE1460 (18AA2138, 18CA1928, 18EAB528), DYKE1466 (18BA1634, 18CA1187, 18DA1776), DYKE1468 (18BA1335, 18EAB838), DYKE1469A (18BA0868, 18DA1474), DYKE1475A (17LA0444, 18AA2019, 18BA1162, 18CA1545), DYKE1480 (18BA0028, 18BA0211, 18BB6704, 18EBQ945, 18OB9926, 18PB5260), DYKE1481 (18BA1471, 18CA1402, 18DA1569, 18EAB051), DYKE1487A (18AA2145, 18BA1736), DYKE1487B (18DA0599), DYKE1488 (18DB7238, 18EBE095), DYKE1491 (18DA0948), DYKE1494 (18BA1450, 18DA1778), DYKE1498 (18CA0824), DYKE1503B (17LA0480, 18AA0783, 18BA0551, 18CA0587, 18DA0778, 18EAA371, 18FAA192), DYKE1506 (18FAA157), DYKE1507 (18DA0591, 18EAB736, 18FAA039), DYKE1516A (18AA1029, 18BA0055, 18BA1034, 18EAB049), DYKE1519 (17IA0093, 18BA1540, 18CA1650, 18EAA320), DYKE1521 (17IA2305, 17JA2046), DYKE1521A (17LA1124, 17LA2004, 18AA2110, 18DA0535), DYKE1526 (17JA0857, 17KA1032, 18AA2090), DYKE1526A (18BA1336, 18CA1705, 18DA1783, 18EAA523, 18FAA247), DYKE1527 (17IA1501, 17KA1034, 18AA0950, 18CA1957, 18DA1731, 18EAB046), DYKE1535 (17JA1057, 17LA0481, 18AA2114, 18DA1728), DYKE1536 (17JA0776, 17KA1944, 18AA1963, 18BA1970, 18DA0211, 18EAA468), DYKE1537 (17JA1066), DYKE1538 (17LA0810, 18BA0475, 18BA2349, 18DA1031, 18EAB415), DYKE1543 (17KA0386, 17LA1373, 18AA2292), DYKE1554 (18AA0653, 18CA1845), DYKE1555 (17LA1505), DYKE1559 (18AA1924, 18BA0444), DYKE1561 (18BA1796, 18DA0372, 18EAB826), DYKE1564 (18CA1183, 18EAA246), DYKE1567 (18CA0739), DYKE1573 (18EAA049, 18FAA288), DYKE1574 (18DA1130, 18DA1594), DYKE1579 (18EAB289, 18EAB583), DYKE1586 (18EAB222), DYKE1588 (18FAA342), DYKE18CMPLY (18CA1467), DYKENDOBASIC (18CA0995, 18DA1811, 18FAA369), DYKENDOBPLUS (18BA1853, 18DA1190, 18FAA207), DYKENDOCLEAN (18DA0382, 18EAB587), DYKENDOCMPLY (18BA1056, 18CA0124, 18DA0129, 18EAB667), DYKENDODBCMP (18BA0916, 18DA0383, 18EAA260, 18EAB752), DYKENDOLWCMP (18DA1812, 18FAA202), DYKENDOUPCMP (18BA1854, 18DA0718, 18EAA508), DYKM1404 (18CA1636, 18DA0654), DYKM1555 (17JA1068, 17LA1482, 18AA1177, 18AA2029, 18AA2612, 18CA0565, 18DA0069, 18EAA433), DYSAMP200458 (18DA1963), DYSAMP200460 (18FAA265), P880995 (18EKD315), P881009 (18EAA498), P971311 (18BA0897, 18CA1642, 18DA0859, 18EAA859), PHS347468000 (18DK2120, 18FKB069); b. Item Number DYK1002DBDE, kit Number (Kit Lot Number): DYK1001DBDE (17IA0598, 17LA0129), DYK1002DBDE (18BA0041), DYK1276244E1 (17JA0713), DYKE1122C (17JA0877, 17JA1514, 17JA2093, 17LA0460, 17LA1984, 18BA2299, 18CA0795, 18CA1927, 18EAA705), DYKE1446A (17JA2156, 17LA1648, 18BA0062, 18CA1226, 18DA1726), DYKE1447A (17IA1474, 17LA1178, 18BA0942), DYKE1516 (17HA1857, 17JA2263), DYKE1539 (17JA1281, 17KA1644, 18AA2157), DYKE1540 (17KA1547), DYKE1540A (18BA0740, 18CA1706, 18DA1020, 18EAB360), DYKE1552 (17LA1291, 18CA0448, 18CA0843), DYKE1580 (18EAA623, 18FAA191); c. Item Number DYK1002DBSE, kit Number (Kit Lot Number): DYK1091457E1 (17LA2255, 18CA0974, 18EAA258), DYK1245641E (17LA1486, 18CA1307), DYKE1000A (17LA0061, 17LA1462, 18CA1093, 18EAA814), DYKE1071 (17LA1174, 18AA0941, 18AA1383), DYKE1110 (18AA1490, 18CA0971, 18DA1557), DYKE1131 (18CA0972, 18EAA321), DYKE1135 (18AA0928, 18BA2275), DYKE1136B (18AA0807, 18AA2529, 18CA0970), DYKE1142 (18AA1125, 18DA0283, 18EAA075), DYKE1144 (18AA0905, 18BA0411, 18CA1924), DYKE1156 (18AA1587, 18CA0976), DYKE1157 (18BA1683, 18CA0975, 18DA1464), DYKE1193 (18AA2159, 18DA0924), DYKE1200B (18AA0869, 18BA2046, 18DA1022), DYKE1201C (17LA2024), DYKE1222B (18AA1458, 18DA0221), DYKE1307A (17JA0617, 17LA1157, 18AA0914, 18CA0967, 18CA1964, 18DA1473), DYKE1392 (17LA1416, 18AA0963, 18DA0376), DYKE1424A (18AA2437, 18CA0985, 18DA1013), DYKE1462A (18BA1818, 18DA1309, 18EAA071), DYKE1505A (17LA2183, 18DA1017), DYKE1533 (17JA0051, 18CA1355), DYKE1581 (18EAA459); d. Item Number DYK1002SBC, kit Number (Kit Lot Number): DYKE1098A (17KA0949, 17LA0422, 18BA0284, 18CA1966, 18DA1296, 18EAA950), DYKE1105 (17JA2744, 17KA1969, 18BB5818, 18EBU560), DYKE1294 (18AA0754), DYKE1363 (17LA0251), DYKE1493 (17KA2116), DYKE1560 (18BA1585, 18DA0003)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3210-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3210-2018	Class II	Terminated	Voluntary: Firm initiated	2018-09-26	2018-09-20

Product code MNL

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)