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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 88353

4 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
July 16, 2021
Product types
Device
Classifications
Class II
Statuses
Completed
Recalling firm wording
Teleflex Medical Europe Ltd

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

4 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 4

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

Z-2319-2021
Recall number
Z-2319-2021
Initiated
July 16, 2021
Classification
Class II
Status
Completed
Quantity
32410 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The firm received reports that the endotracheal tube cuff could be inflated while the pilot balloon remained flat.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The firm received reports that the endotracheal tube cuff could be inflated while the pilot balloon remained flat.

Code information

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

Distribution pattern

US Nationwide distribution.

device · product 2 of 4

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

Z-2320-2021
Recall number
Z-2320-2021
Initiated
July 16, 2021
Classification
Class II
Status
Completed
Quantity
155030 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The firm received reports that the endotracheal tube cuff could be inflated while the pilot balloon remained flat.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The firm received reports that the endotracheal tube cuff could be inflated while the pilot balloon remained flat.

Code information

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

Distribution pattern

US Nationwide distribution.

device · product 3 of 4

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

Z-2321-2021
Recall number
Z-2321-2021
Initiated
July 16, 2021
Classification
Class II
Status
Completed
Quantity
2610 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The firm received reports that the endotracheal tube cuff could be inflated while the pilot balloon remained flat.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The firm received reports that the endotracheal tube cuff could be inflated while the pilot balloon remained flat.

Code information

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

Distribution pattern

US Nationwide distribution.

device · product 4 of 4

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

Z-2322-2021
Recall number
Z-2322-2021
Initiated
July 16, 2021
Classification
Class II
Status
Completed
Quantity
638220 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The firm received reports that the endotracheal tube cuff could be inflated while the pilot balloon remained flat.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The firm received reports that the endotracheal tube cuff could be inflated while the pilot balloon remained flat.

Code information

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

Distribution pattern

US Nationwide distribution.