Lower risk Medical device recall · FDA · Published November 24, 2025

Draeger Vapor 2000 Anesthetic Vaporizer Recall: Impure Component Risk

Draeger recalls unheated anesthetic vaporizers with specific serial numbers due to impure components that may not meet calibration standards. Affected units include models M35054 with serial numbers starting ASUK-0421 to ASUK-1532.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0933-2026Medical device Draeger ›

Lower-risk recall

A certain component of affected devices was not delivered within specification and contained impurities.

Take action

Contact the company

Recalling firmDraeger, Inc.3135 Quarry Rd · Telford, PA 18969-1042

✎ GovInfoNow plain-language explainer

Draeger is recalling its Vapor 2000 anesthetic vaporizers because a component contained impurities that could affect calibration. This means the device might not deliver the correct anesthetic dosage, which could impact medical treatments. Read more at govinfonow.com/recall/50611-draeger-vapor-2000-anesthetic-vaporizer-recall-impure-component-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/50611-draeger-vapor-2000-anesthetic-vaporizer-recall-impure-component-risk · Updated August 17, 2026 · FDA enforcement record: FDA #Z-0933-2026

Cite this page

“Draeger Vapor 2000 Anesthetic Vaporizer Recall: Impure Component Risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/50611-draeger-vapor-2000-anesthetic-vaporizer-recall-impure-component-risk. Based on FDA recall #Z-0933-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0933-2026%22&limit=1).

The FDA announced on 2025-11-24 that Draeger, Inc. is recalling its Draeger Vapor 2000 unheated, calibrated anesthetic vaporizer because a component was not delivered within specification and contained impurities. The agency issued recall number Z-0933-2026 for the Class I voluntary recall.

How to tell if you have it

Brand: Draeger
Product: Draeger Vapor 2000
Model No.: M35054
UDI-DI: 04048675228059
Serial Nos.: ASUK-0421 through ASUK-1532 (as listed in record)
Units affected: 431

The hazard

A certain component of the affected devices was not delivered within specification and contained impurities. The FDA classified this as a Class I recall.

Context

GovInfoNow's records show Draeger, Inc. has had 6 other recalls since 2025-03-12. Recent similar product recalls include the Mindray Isoflurane V90 Vaporizer Recall (2025-10-20), the Mindray Sevoflurane V90 Vaporizer Recall (2025-10-20), and the B Braun Anesthesia IV Set Recall (2025-10-29).

How to tell if you have this one

Check for the model number M35054 and serial numbers starting with ASUK-0421 to ASUK-1532. The device is an unheated, calibrated anesthetic vaporizer.

Brand
Draeger
Category
Medical device

FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class I
Status
Ongoing
Distribution
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.

Recall number	Product, codes & lots	Quantity
Z-0933-2026	Draeger Vapor 2000. Unheated, calibrated anesthetic vaporizer.; Model No. M35054; UDI-DI: 04048675228059; Serial No. 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.	431 units
Z-0934-2026	Draeger Vapor 3000. Unheated, calibrated anesthetic vaporizer.; Model No. M36500; UDI-DI: 04048675301363; Serial No. ASUK-1181,ASUK-1186,ASUK-1187,ASUK-1196,ASUK-1197,ASUK-1198,ASUK-1199,ASUK-1200, ASUK-1201,ASUK-1202,ASUK-1203,ASUK-1204,ASUK-1205,ASUK-1206,ASUK-1207,ASUK-1208, ASUK-1209,ASUK-1210,ASUK-1211,ASUK-1212,ASUK-1213,ASUK-1214,ASUK-1215,ASUK-1216, ASUK-1217,ASUK-1218,ASUK-1219,ASUK-1220,ASUK-1590,ASUK-1591,ASUK-1592,ASUK-1611, ASUK-1613,ASUK-1616,ASUK-1617,ASUK-1618,ASUK-1619, ASUK-0241,ASUK-0242,ASUK-0243,ASUK-0244,ASUK-0245,ASUK-0246,ASUK-0247,ASUK-0248, ASUK-0249,ASUK-0250,ASUK-0451,ASUK-0452,ASUK-0453,ASUK-0454,ASUK-0455,ASUK-0456, ASUK-0457,ASUK-0458,ASUK-0459,ASUK-0460,ASUK-0461,ASUK-0462,ASUK-0463,ASUK-0464, ASUK-0465,ASUK-0466,ASUK-0467,ASUK-0468,ASUK-0469,ASUK-0470,ASUK-0471,ASUK-0472, ASUK-0473,ASUK-0474,ASUK-0475,ASUK-0476,ASUK-0477,ASUK-0478,ASUK-0479,ASUK-0480, ASUK-0481,ASUK-0482,ASUK-0483,ASUK-0484,ASUK-0486,ASUK-0487,ASUK-0488,ASUK-0489, ASUK-0490,ASUK-0491,ASUK-0492,ASUK-0493,ASUK-0494,ASUK-0495,ASUK-0496,ASUK-0497, ASUK-0498,ASUK-0499,ASUK-0500,ASUK-0501,ASUK-0502,ASUK-0503,ASUK-0504,ASUK-0505, ASUK-0506,ASUK-0507,ASUK-0508,ASUK-0509,ASUK-0510,ASUK-0511,ASUK-0512,ASUK-0513, ASUK-0514,ASUK-0515,ASUK-0516,ASUK-0517,ASUK-0518,ASUK-0519,ASUK-0520,ASUK-0521, ASUK-0522,ASUK-0523,ASUK-0524,ASUK-0525,ASUK-0526,ASUK-0527,ASUK-0528,ASUK-0529, ASUK-0530,ASUK-0531,ASUK-0532,ASUK-0533,ASUK-0534,ASUK-0535,ASUK-0536,ASUK-0537, ASUK-0538,ASUK-0539,ASUK-0540,ASUK-0541,ASUK-0542,ASUK-0543,ASUK-0544,ASUK-0545, ASUK-0546,ASUK-0547,ASUK-0548,ASUK-0549,ASUK-0550,ASUK-0551,ASUK-0552,ASUK-0553, ASUK-0554,ASUK-0555,ASUK-0556,ASUK-0557,ASUK-0558,ASUK-0559,ASUK-0560,ASUK-1181, ASUK-1182,ASUK-1183,ASUK-1184,ASUK-1185,ASUK-1191,ASUK-1192,ASUK-1193,ASUK-1194, ASUK-1195,ASUK-1581,ASUK-1582,ASUK-1583,ASUK-1584,ASUK-1585,ASUK-1586,ASUK-1587, ASUK-1588,ASUK-1589,ASUK-1593,ASUK-1594,ASUK-1595,ASUK-1596,ASUK-1597,ASUK-1598, ASUK-1599,ASUK-1600,ASUK-1602,ASUK-1612,ASUK-1614,,ASUK-1615,ASUK-1620.	188 units

Based on the official FDA remedy

What to do — step by step

Check Device Serial Number
Look for the serial number on the device, which starts with ASUK-0421 to ASUK-1532 for affected units.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 16 states.

FDA distribution: “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,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alaska, California, Florida, Iowa, Kansas, Maine, Maryland, Minnesota, New York, Ohio, Pennsylvania, Rhode Island, South Dakota, Tennessee, Texas, Utah.

Recall timeline

FDA published this recall 37 days after the firm started it.

Nov 24, 2025Firm started the recall
Dec 23, 2025FDA classified it Class I
Dec 31, 2025Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/50611-draeger-vapor-2000-anesthetic-vaporizer-recall-impure-component-risk">Draeger Vapor 2000 Anesthetic Vaporizer Recall: Impure Component Risk (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0933-2026 (November 24, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0933-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.