Draeger, Inc. recalls Draeger Vapor 2000. Unheated
Reason for recall
A certain component of affected devices was not delivered within specification and contained impurities.
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
Draeger Vapor 2000. Unheated, calibrated anesthetic vaporizer.
Lot / code information
- Model
- M35054
- UDI
- 04048675228059
- Serial #
ASUK-0421, ASUK-0422, ASUK-0423, ASUK-0424, ASUK-0425, ASUK-0426 — +426 moreShow all
ASUK-0421,ASUK-0422,ASUK-0423,ASUK-0424,ASUK-0425,ASUK-0426,ASUK-0602,ASUK-0603, ASUK-0705,ASUK-0706,ASUK-0707,ASUK-0708,ASUK-0721,ASUK-0722,ASUK-0723,ASUK-0724, ASUK-0725,ASUK-0726,ASUK-0727,ASUK-0728,ASUK-0729,ASUK-0730,ASUK-0731,ASUK-0732, ASUK-0733,ASUK-0734,ASUK-0735,ASUK-0736,ASUK-0737,ASUK-0738,ASUK-0739,ASUK-0740, ASUK-0749,ASUK-0761,ASUK-0762,ASUK-0763,ASUK-0764,ASUK-0765,ASUK-0766,ASUK-0767, ASUK-0768,ASUK-0769,ASUK-0770,ASUK-0835,ASUK-0836,ASUK-0837,ASUK-0972,ASUK-0973, ASUK-0974,ASUK-0975,ASUK-0993,ASUK-0994,ASUK-0995,ASUK-0996,ASUK-0997,ASUK-0998, ASUK-0999,ASUK-1000,ASUK-1011,ASUK-1015,ASUK-1016,ASUK-1017,ASUK-1018,ASUK-1221, ASUK-1222,ASUK-1232,ASUK-1233,ASUK-1234,ASUK-1235,ASUK-1236,ASUK-1237,ASUK-1239, ASUK-1240,ASUK-1246,ASUK-1306,ASUK-1307,ASUK-1308,ASUK-1309,ASUK-1539,ASUK-1540, ASUK-0428,ASUK-0429,ASUK-0430,ASUK-0431,ASUK-0432,ASUK-0433,ASUK-0434,ASUK-0435, ASUK-0436,ASUK-0437,ASUK-0438,ASUK-0439,ASUK-0440,ASUK-0441,ASUK-0442,ASUK-0443, ASUK-0444,ASUK-0445,ASUK-0446,ASUK-0447,ASUK-0448,ASUK-0449,ASUK-0450,ASUK-0,63, ASUK-0564,ASUK-0565,ASUK-0566,ASUK-0567,ASUK-0568,ASUK-0569,ASUK-0570,ASUK-0571, ASUK-0572,ASUK-0573,ASUK-0574,ASUK-0575,ASUK-0576,ASUK-0577,ASUK-0578,ASUK-0579, ASUK-0580,ASUK-0581,ASUK-0582,ASUK-0583,ASUK-0584,ASUK-0585,ASUK-0601,ASUK-0604, ASUK-0605,ASUK-0606,ASUK-0607,ASUK-0608,ASUK-0609,ASUK-0610,ASUK-0631,ASUK-0632, ASUK-0633,ASUK-0634,ASUK-0635,ASUK-0636,ASUK-0637,ASUK-0638,ASUK-0639,ASUK-0640, ASUK-0641,ASUK-0642,ASUK-0661,ASUK-0662,ASUK-0663,ASUK-0664,ASUK-0667,ASUK-0668, ASUK-0681,ASUK-0682,ASUK-0691,ASUK-0692,ASUK-0693,ASUK-0694,ASUK-0695,ASUK-0696, ASUK-0697,ASUK-0698,ASUK-0699,ASUK-0700,ASUK-0711,ASUK-0712,ASUK-0713,ASUK-0714, ASUK-0715,ASUK-0716,ASUK-0717,ASUK-0718,ASUK-0719,ASUK-0720,ASUK-0741,ASUK-0742, ASUK-0743,ASUK-0744,ASUK-0746,ASUK-0747,ASUK-0748,ASUK-0750,ASUK-0751,ASUK-0752, ASUK-0753,ASUK-0754,ASUK-0755,ASUK-0756,ASUK-0757,ASUK-0758,ASUK-0759,ASUK-0760, ASUK-0778,ASUK-0779,ASUK-0780,ASUK-0781,ASUK-0782,ASUK-0783,ASUK-0784,ASUK-0785, ASUK-0786,ASUK-0787,ASUK-0788,ASUK-0789,ASUK-0790,ASUK-0791,ASUK-0792,ASUK-0793, ASUK-0794,ASUK-0795,ASUK-0796,ASUK-0797,ASUK-0798,ASUK-0799,ASUK-0800,ASUK-0801, ASUK-0802,ASUK-0803,ASUK-0804,ASUK-0805,ASUK-0810,ASUK-0816,ASUK-0817,ASUK-0818, ASUK-0819,,ASUK-0820,ASUK-0821,ASUK-0822,ASUK-0823,ASUK-0824,ASUK-0825,ASUK-0826, ASUK-0827,ASUK-0828,ASUK-0829,ASUK-0830,ASUK-0831,ASUK-0832,ASUK-0833,ASUK-0834, ASUK-0838,ASUK-0839,ASUK-0840,ASUK-0842,ASUK-0843,ASUK-0844,ASUK-0845,ASUK-0846, ASUK-0847,ASUK-0848,ASUK-0849,ASUK-0850,ASUK-0851,ASUK-0852,ASUK-0853,ASUK-0854, ASUK-0855,ASUK-0856,ASUK-0857,ASUK-0858,ASUK-0859,ASUK-0860,ASUK-0871,ASUK-0872, ASUK-0873,ASUK-0874,ASUK-0875,ASUK-0876,ASUK-0877,ASUK-0878,ASUK-0879,ASUK-0880, ASUK-0891,ASUK-0892,ASUK-0893,ASUK-0894,ASUK-0916,ASUK-0917,ASUK-0918,ASUK-0919, ASUK-0920,ASUK-0921,ASUK-0922,ASUK-0923,ASUK-0924,ASUK-0925,ASUK-0930,ASUK-0931, ASUK-0964,ASUK-0965,ASUK-0971,ASUK-0976,ASUK-0977,ASUK-0978,ASUK-0979,ASUK-0980, ASUK-0981,ASUK-0982,ASUK-0983,ASUK-0984,ASUK-0985,ASUK-0986,ASUK-0987,ASUK-0988, ASUK-0989,ASUK-0990,ASUK-0991,ASUK-0992,ASUK-1001,ASUK-1002,ASUK-1003,ASUK-1005, ASUK-1006,ASUK-1007,ASUK-1008,ASUK-1009,ASUK-1010,ASUK-1012,ASUK-1014,ASUK-1019, ASUK-1020,ASUK-1061,ASUK-1062,ASUK-1063,ASUK-1064,ASUK-1065,ASUK-1066,ASUK-1070, ASUK-1071,ASUK-1073,ASUK-1074,ASUK-1075,ASUK-1076,ASUK-1077,ASUK-1078,ASUK-1079, ASUK-1080,ASUK-1081,ASUK-1082,ASUK-1084,ASUK-1085,ASUK-1086,ASUK-1087,ASUK-1088, ASUK-1089,ASUK-1090,ASUK-1091,ASUK-1092,ASUK-1093,ASUK-1094,ASUK-1095,ASUK-1096, ASUK-1097,ASUK-1098,ASUK-1099,ASUK-1100,ASUK-1121,ASUK-1122,ASUK-1123,ASUK-1124, ASUK-1125,ASUK-1126,ASUK-1127,ASUK-1128,ASUK-1129,ASUK-1130,ASUK-1230,ASUK-1231, ASUK-1241,ASUK-1242,ASUK-1243,ASUK-1244,ASUK-1245,ASUK-1247,ASUK-1261,ASUK-1262, ASUK-1263,ASUK-1264,ASUK-1265,ASUK-1266,ASUK-1267,ASUK-1268,ASUK-1269,ASUK-1270, ASUK-1271,ASUK-1272,ASUK-1273,ASUK-1274,ASUK-1275,ASUK-1276,ASUK-1277,ASUK-1278, ASUK-1279,ASUK-1280,ASUK-1288,ASUK-1289,ASUK-1291,ASUK-1292,ASUK-1293,ASUK-1294, ASUK-1295,ASUK-1296,ASUK-1297,ASUK-1298,ASUK-1299,ASUK-1300,ASUK-1301,ASUK-1302, ASUK-1305,ASUK-1311,ASUK-1312,ASUK-1313,ASUK-1314,ASUK-1315,ASUK-1352,ASUK-1353, ASUK-1357,ASUK-1358,ASUK-1360,ASUK-1463,ASUK-1464,ASUK-1465,ASUK-1466,ASUK-1492, ASUK-1493,ASUK-1496,ASUK-1497,ASUK-1498,ASUK-1499,ASUK-1500,ASUK-1532
What the firm is doing
Consignees were mailed an Urgent Medical Device Recall notification dated November 2025. The notification recommends that consignees do not use affected vaporizers and return the provided reply card to confirm this. A Draeger representative will contact consignees to arrange replacement of affected vaporizers. If affected vaporizers have been placed into clinical use, Draeger asks that consignees clean the breathing system of the anesthesia device according to the IFU and use of inspiratory filters is recommended. Consignees are to share the recall notification with all users of affected devices to ensure awareness and forward the notice if product was further distributed. Questions regarding operation of devices are to be directed to Drager Service Technical Support at 1-800-437-2437 (Option 2, 2, 2). Questions about the recall notice are to be directed to Michael Kelhart via email at mike.kelhart@draeger.com or phone at 267-664-1131.
DistributionShow detailsHide
Worldwide - US Nationwide distribution in the states of AK, CA, FL, IA, KS, MD, ME, MN, NY, OH, PA, RI, SD, TN, TX, UT, W and the countries of Argentina, Australia, Belgium, Brazil, Cambodia, China, Columbia, Czech Republic, Ecuador, Egypt, France, Germany, Greece, Guatemala, Hungary, Indonesia, Israel, Japan, Kenya, Mexico, Nepal, Norway, Panama, Peru, Philippines, Poland, Romania, Saudi Arabia, Serbia, Singapore, Spain, Thailand, Turkey, United Kingdom, United Arab Emirates, Vietnam.
A reasonable probability that use of the product will cause serious adverse health consequences or death.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-0933-2026
- FDA 510(k) clearance · K971923The device's official FDA premarket clearance record
- FDA device classification · CADOfficial FDA classification for this device type
- CFR regulation · 21 CFR 868.5880The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find Draeger, Inc.Search for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
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