Medline Industries Inc: 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

Recall number

Z-3210-2018

Recalling firm

Medline Industries Inc

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

Status

Terminated

Initiated

2018-06-15

Posted

2018-10-11

Terminated

2020-05-18

Reason

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.

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

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

Lot, serial or model codes

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)

510(k) numbers

not on file

PMA numbers

not on file

Product code

MNL

Firm FEI

1417592

Firm city

Northfield

Firm state

IL

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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