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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device

Teleflex Medical Europe Ltd: The firm received reports that the endotracheal tube cuff could be inflated while the pilot balloon remained flat.

Agency Publication Date: August 19, 2021
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Affected Products

Product: RUSCH Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF numbers: a) 170050 b) 170055 c) 170060 d) 170065 e) 170070 f) 170075 g) 170080 h) 170085 i) 170090 j) 170095

a) 170050, Lot Numbers: KME20K2551, KME20L1089, KME20L2371, KME21A2064, KME21B2498, KME21C0488 b) 170055, Lot Numbers: KME20K0936, KME20K2587, KME20L1469, KME20L2378, KME21A0383, KME21A1901, KME21B2682, KME21C2708 c) 170060, Lot Numbers: KME20L1487, KME20L2379, KME20M0494, KME21A0384, KME21A1482, KME21C0293 d) 170065, Lot Numbers: KME20K0938, KME20K2623, KME20L0487, KME20L1705, KME20M1578, KME20M1751, KME20M2709, KME21A0385, KME21A1812, KME21B1670, KME21B2499, KME21B2500, KME21C1592, KME21C2266, KME21C2504, KME21C2706, KME21D1043 e) 170070, Lot Numbers: KME20K2544, KME20L0053, KME20L0055, KME20L0942, KME20L2372, KME20M0381, KME20M0665, KME20M1103, KME20M1754, KME20M1755, KME21A0893, KME21A2264, KME21B1074, KME21B1075, KME21C0463, KME21C0464, KME21C1027, KME21C1422, KME21C1592, KME21C2266, KME21C2504, KME21C2706, KME21D1043 f) 170075, Lot Numbers: KME20K1352, KME20L1132, KME20M0033, KME20M0382, KME20M1149, KME20M1225, KME20M1227, KME20M1537, KME20M2881, KME20M2882, KME21A0824, KME21A1161, KME21A1813, KME21B0813, KME21C0212, KME21C0213, KME21C1594, KME21C1895, KME21C2855, KME21C3294, KME21C3295 g) 170080, Lot Numbers: KME20L0396, KME20L1278, KME20L1279, KME20L2830, KME20M0847 , KME21A0386, KME21A2800, KME21A2801, KME21B1245, KME21B1752, KME21B2156, KME21C0465, KME21C0533, KME21C2826 h) 170085, Lot Numbers: KME20L0398, KME20L2376, KME20M3247, KME21A1894, KME21C0298, KME21C2385 i) 170090, Lot Numbers: KME20L0625 j) 170095, Lot Numbers: KME20M0384, KME21B0407

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Product: RUSCH Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF numbers: a) 504550 b) 504555 c) 504560 d) 504565 e) 504570 f) 504575 g) 504580 f) 504585 g) 504590

a) 504550, Lot Numbers: KME20K0001, KME20K0467, KME20K1581, KME20L0618, KME20L1090, KME20L2027, KME20M0019, KME21A2076, KME21A2787, KME21B1140, KME21C0059, KME21C2363 b) 504555, Lot Numbers: KME20K0765, KME20K0766, KME20K0935, KME20K1582, KME20L0619, KME20L1857, KME20L2028, KME20M0020, KME21A1902, KME21A2796, KME21B2681, KME21C2707 c) 504560, Lot Numbers: KME20K1550, KME20L0336, KME20L2298, KME20M0021, KME20M0492, KME21A0380, KME21A0817, KME21A1160, KME21A1770, KME21B1137, KME21B1138, KME21B1139, KME21C3255 d) 504565, Lot Numbers: KME20K0465, KME20K0939, KME20K1551, KME20K1628, KME20K2246, KME20L0488, KME20L1840, KME20M0022, KME20M0854, KME20M1102, KME20M1579, KME21A0085, KME21A1040, KME21A1292, KME21A2794, KME21B1141, KME21B1669, KME21B2155, KME21B2501, KME21B2502, KME21B2855, KME21C0025, KME21C1202, KME21C1331, KME21C1790, KME21C1897, KME21C2188, KME21C2262, KME21C2835 e) 504570, Lot Numbers: KME20K0026, KME20K0360, KME20K0361, KME20K0768, KME20K0941, KME20K1148, KME20K1202, KME20K1304, KME20K1552, KME20K1658, KME20K2057, KME20K2187, KME20K3161, KME20K3355, KME20L0057, KME20L0059, KME20L0490, KME20L0623, KME20L0943, KME20L0944, KME20L1091, KME20L1122, KME20L1124, KME20L1475, KME20L1844, KME20L2039, KME20L2258, KME20L2827, KME20M0378, KME20M0379, KME20M0380, KME20M0498, KME20M1105, KME20M1153, KME20M1156, KME21A0228, KME21A0273, KME21A0304, KME21A0305, KME21A1769, KME21A2227, KME21A2228, KME21A2229, KME21A2263, KME21A3119, KME21A3120, KME21A3121, KME21B0261, KME21B0338, KME21B0559, KME21B0750, KME21B1073, KME21B1751, KME21B2107, KME21B2153, KME21B2460, KME21B2719, KME21B2721, KME21C0123, KME21C0376, KME21C0421, KME21C0620, KME21C0634, KME21C1016, KME21C1333, KME21C1416, KME21C1434, KME21C1489, KME21C1593, KME21C1653, KME21C1703, KME21C1786, KME21C1896, KME21C2065, KME21C2146 f) 504575, Lot Numbers: KME20K0769, KME20K0770, KME20K1150, KME20K1204, KME20K1665, KME20K2188, KME20K2920, KME20K3016, KME20K3018, KME20K3159, KME20K3575, KME20L1476, KME20L2374, KME20M0383, KME20M1151, KME20M2051, KME20M2344, KME20M2376, KME20M2485, KME20M2556, KME21A0084, KME21A0303, KME21A0671, KME21A0672, KME21A0673, KME21A0674, KME21A0812, KME21A1041, KME21A1464, KME21A1605, KME21A2799, KME21A2815, KME21B0753, KME21B0814, KME21B0888, KME21B0889, KME21B0931, KME21B1240, KME21B2461, KME21B2462, KME21B2465, KME21B2716, KME21B2717, KME21C0700, KME21C0972, KME21C1203, KME21C1336, KME21C1435, KME21C1893, KME21C2565, KME21C2610 g) 504580, Lot Numbers: KME20K0449, KME20K0450, KME20K1414, KME20K2622, KME20L1277, KME20L1479, KME20L2302, KME20L2828, KME20M1752, KME20M1753, KME21A0381, KME21A0820, KME21A0823, KME21A1291, KME21A1604, KME21B0339, KME21B1241, KME21B1855, KME21B2108, KME21B2154, KME21B2697, KME21C0377, KME21C0623, KME21C2407, KME21C2738, KME21C3448 f) 504585, Lot Numbers: KME20K2625, KME20L0624, KME20L1482, KME20L2303, KME20L2832, KME21A0891, KME21A1043, KME21A2802, KME21A2803, KME21B0933, KME21B1250, KME21B1251, KME21B2029, KME21C0506, KME21C2107, KME21C2339, KME21C2341, KME21C2553, KME21D0210 g) 504590, Lot Numbers: KME20L0626, KME20M0856, KME20M2091, KME21C0299, KME21C2104, KME21C2105

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Product: RUSCH Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF numbers: a) 112080050 b) 112080055 c) 112080060 d) 112080065 e) 112080070 f) 112080075 g) 112080080 h) 112080085 i) 112080090 j) 112080095 k) 112080100

a) 112080050, Lot Numbers: KME20K1512, KME20L1145, KME20M2383, KME21B0357 b) 112080055, Lot Numbers: KME20K2579, KME21A2569, KME21C1978 c) 112080060, Lot Numbers: KME20M0616, KME20M2112, KME21A2685 d) 112080065, Lot Numbers: KME20K2581, KME21C1701 e) 112080070, Lot Numbers: KME20K2577, KME20L1985, KME20M1771, KME20M1772, KME20M2856, KME21A2355, KME21B1624, KME21B2490, KME21C1184 f) 112080075, Lot Numbers: KME20K0110 g) 112080080, Lot Numbers: KME20M0377, KME21B2727, KME21C0500 h) 112080085, Lot Numbers: KME20M0909, KME21B0519, KME21C0067 i) 112080090, Lot Numbers: KME20K1808, KME20L2352, KME20M2248 j) 112080095, Lot Numbers: KME20K2310, KME20L1153 k) 112080100 Lot Numbers: KME20K1005, KME20L1144

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Product: RUSCH Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF numbers: a) 112082050 b) 112082055 c) 112082060 d) 112082065 e) 112082070 f) 112082075 g) 112082080 h) 112082085 i) 112082090 j) 112082095 k) 112082100

a) 112082050, Lot Numbers: KME20K0211, KME20K0463, KME21A2017, KME21A2343, KME21A2686, KME21B2491 b) 112082055, Lot Numbers: KME20K0464, KME20K0683, KME20L1703, KME20M0996, KME21A0492, KME21A1433, KME21C0502, KME21C1347, KME21C1496, KME21C2745, KME21D0835 c) 112082060, Lot Numbers: KME20K0435, KME20K1112, KME20K2168, KME20K3530, KME20L0196, KME20L1143, KME20L1420, KME20L2089, KME20L2783, KME20M0497, KME20M0663, KME20M1064, KME20M1143, KME20M1218, KME21A1521, KME21A1803, KME21A2066, KME21A2344, KME21B0252, KME21B1151, KME21B1592, KME21B2606, KME21B2729, KME21C0483, KME21C1094, KME21C2681, KME21C2996, KME21D0703, KME21D1159, KME21D1326 d) 112082065, Lot Numbers: KME20K0036, KME20K0259, KME20K0436, KME20K0504, KME20K0677, KME20K0881, KME20L1421, KME20L1436, KME20L2349, KME20L2447, KME20L2448, KME20M0710, KME20M0892, KME20M0928, KME20M1806, KME20M1923, KME20M2249, KME20M2450, KME20M2708, KME21A0338, KME21A0404, KME21A0695, KME21A1588, KME21A1779, KME21A2102, KME21A2230, KME21A2572, KME21B1352, KME21B2607, KME21B2789, KME21B2856, KME21C0504, KME21C0981, KME21C0983, KME21C1035, KME21C1036, KME21C1097, KME21C1925, KME21C2997, KME21C3166, KME21C3456 e) 112082070, Lot Numbers: KME20J2802, KME20K0061, KME20K0437, KME20K0462, KME20K0585, KME20K1007, KME20K3013, KME20K3014, KME20K3145, KME20K3365, KME20K3448, KME20K3518, KME20K3560, KME20L0276, KME20L0371, KME20L0785, KME20L0928, KME20L1691, KME20L1752, KME20L1858, KME20L1874, KME20L1923, KME20L2111, KME20L2210, KME20L2273, KME20L2350, KME20L2373, KME20L2463, KME20L2478, KME20L2499, KME20L2699, KME20L2826, KME20M0490, KME20M0664, KME20M0712, KME20M0762, KME20M0774, KME20M0839, KME21A1121, KME21A1215, KME21A1328, KME21A2220, KME21A2345, KME21A2574, KME21A2984, KME21A3038, KME21B0136, KME21B0711, KME21B2898, KME21C0505, KME21C0567, KME21C0701, KME21C0737, KME21C0822, KME21C0854, KME21C0971, KME21C0973, KME21C1279, KME21C1328, KME21C1655, KME21C1702, KME21C2150, KME21C2403, KME21C2568, KME21C2875, KME21C2954, KME21D0350, KME21D0435, KME21D0491, KME21D0714, KME21D0715, KME21D1218, KME21D1409 f) 112082075, Lot Numbers: KME20J3284, KME20K0052, KME20K0181, KME20K1113, KME20K3044, KME20K3577, KME20L0484, KME20L0755, KME20L1092, KME20L1156, KME20L1298, KME20L1299, KME20L1704, KME20L1924, KME20L1983, KME20L2605, KME20L2798, KME20M0034, KME20M0321, KME20M1067, KME20M1507, KME20M1890, KME20M2212, KME21A3004, KME21A3259, KME21B0179, KME21B0823, KME21B2480, KME21B2482, KME21C0239, KME21C0264, KME21C0614, KME21C0615, KME21C0661, KME21C0702, KME21C0730, KME21C0826, KME21C0855, KME21C1093, KME21C1223, KME21C1323, KME21C1399, KME21C1601, KME21C1704, KME21C1746, KME21C1944, KME21C2008, KME21C2026, KME21C2051, KME21C2066, KME21C2195, KME21C2499, KME21C2615, KME21C2680, KME21C2766, KME21C2908, KME21C2964, KME21C3394, KME21D0029, KME21D0058, KME21D0186, KME21D0586, KME21D0648, KME21D0775, KME21D1103, KME21D1400, KME21D1423 g) 112082080, Lot Numbers: KME20J2998, KME20J3341, KME20K3520, KME20L0194, KME20L1157, KME20L1237, KME20L1706, KME20L2207, KME20L2333, KME20L2375, KME20L2607, KME20L2696, KME20M0577, KME20M1043, KME20M1069, KME20M1260, KME20M1342, KME20M1780, KME20M2363, KME21A0082, KME21A1435, KME21A1522, KME21A1524, KME21A2014, KME21A2058, KME21A2576, KME21B0049, KME21B0137, KME21B0248, KME21B0428, KME21B0616, KME21B0709, KME21B0863, KME21B1214, KME21B1284, KME21B2488, KME21B2489, KME21C0705, KME21C0706, KME21C1063, KME21C1325, KME21C1441, KME21C1745, KME21C1785, KME21C2068, KME21C3283, KME21C3320 h) 112082085, Lot Numbers: KME20J2999, KME20K0923, KME20K1114, KME20K1273, KME20K1513, KME20K3020, KME20K3034, KME20K3146, KME20L0670, KME20L0756, KME20L0757, KME20L1437, KME20L1549, KME20L1678, KME20L1707, KME20L1867, KME20L2274, KME20L2831, KME20M1511, KME20M1548, KME20M1849, KME20M3122, KME20M3248, KME21A0697, KME21A1093, KME21A2265, KME21A2577, KME21B0932, KME21B0958, KME21B1215, KME21C3024, KME21C3324, KME21D0061 i) 112082090, Lot Numbers: KME20K0180, KME20K0212, KME20K0600, KME20K0978, KME20K1434, KME20K3021, KME20K3525, KME20L0805, KME20L1142, KME21A2016, KME21A2676, KME21A3263, KME21B0632, KME21B1283 j) 112082095, Lot Numbers: KME20K1583, KME20K1831, KME20K2166, KME20K2574, KME20L1041, KME20L1592, KME20L2462, KME20L2557, KME20M2115, KME20M2198, KME21A2346, KME21A3264, KME21B1895, KME21C3326 k) 112082100, Lot Numbers: KME20K0977, KME20K1809, KME20K2553, KME20L0335, KME20M1341, KME20M2113, KME21A2342, KME21A2668, KME21C0017, KME21C0068, KME21D0827, KME21D1219

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Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 88353
Status: Active
Manufacturer: Teleflex Medical Europe Ltd
Manufactured In: Ireland
Units Affected: 4 products (32410 units; 155030 units; 2610 units; 638220 units)

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.