Urgent site urgencyFDA Class I
Atlan A350XL
The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.
- Agency
- FDA Device
- Recall date
- May 7, 2026
- Status
- Ongoing
- Company
- Draeger, Inc.
1. What product was recalled?
Atlan A350
Atlan A350. Model Number: 8211500. anesthesia workstation
Quantity: 3,515 units
Code or lot text: Model Number: 8211500. UDI-DI Number: 04048675556176.Serial Numbers: ASSL-0347, ASSL-0348, ASSL-0351, ASSH-0220, ASSH-0221, ASSH-0224, ASSH-0225, ASSH-0228, ASSH-0229, ASSH-0230, ASSH-0234, ASSH-0235, ASTA-0086, ASSL-0349, ASSL-0350, ASSL-0352, ASSL-0353, ASSH-0222, ASSH-0223, ASSH-0226, ASSH-0227, ASSH-0231, ASSH-0232, ASSH-0233, ASSH-0236, ASSH-0237, ASSH-0238, ASSN-0185, ASSN-0186, ASSN-0187, ASSN-0188, ASSN-0189, ASSN-0190, ASTB-0037, ASTB-0040, ASTA-0087, ASTA-0088, ASSM-0130, ASSM-0131, ASSM-0132.
- LOT
- ASSH-0220
- LOT
- ASSH-0221
- LOT
- ASSH-0222
- LOT
- ASSH-0223
- LOT
- ASSH-0224
- LOT
- ASSH-0225
- LOT
- ASSH-0226
- LOT
- ASSH-0227
- LOT
- ASSH-0228
- LOT
- ASSH-0229
- LOT
- ASSH-0230
- LOT
- ASSH-0231
- LOT
- ASSH-0232
- LOT
- ASSH-0233
- LOT
- ASSH-0234
- LOT
- ASSH-0235
- LOT
- ASSH-0236
- LOT
- ASSH-0237
- LOT
- ASSH-0238
- LOT
- ASSL-0348
- LOT
- ASSL-0349
- LOT
- ASSL-0350
- LOT
- ASSL-0351
- LOT
- ASSL-0352
- LOT
- ASSL-0353
- LOT
- ASSM-0130
- LOT
- ASSM-0131
- LOT
- ASSM-0132.
- LOT
- ASSN-0185
- LOT
- ASSN-0186
- LOT
- ASSN-0187
- LOT
- ASSN-0188
- LOT
- ASSN-0189
- LOT
- ASSN-0190
- LOT
- ASTA-0086
- LOT
- ASTA-0087
- LOT
- ASTA-0088
- LOT
- ASTB-0037
- LOT
- ASTB-0040
- LOT
- Model Number: 8211500. UDI-DI Number: 04048675556176.Serial Numbers: ASSL-0347
- RECALL-NUMBER
- Z-2207-2026
Atlan A350XL
Atlan A350XL. Model Number: 8621600. anesthesia workstation
Quantity: 394 units
Code or lot text: Model Number: 8621600. UDI-DI Number: 04048675556183. Serial Numbers: ASSL-0354, ASSL-0357, ASSL-0360, ASSH-0240, ASSH-0242, ASSH-0243, ASSH-0245, ASSH-0246, ASSH-0247, ASSH-0248, ASSH-0249, ASSH-0250, ASSL-0355, ASSL-0356, ASSL-0358, ASSL-0359, ASSL-0361, ASSH-0239, ASSH-0241, ASSH-0244, ASSH-0251, ASSH-0252, ASSH-0253, ASSH-0254, ASTA-0308, ASTA-0310, ASTA-0312, ASTA-0271, ASTA-0272, ASTA-0273, ASTA-0274, ASTA-0275, ASTA-0276, ASTA-0352, ASTA-0354, ASTA-0364, ASTA-0395, ASTA-0396, ASTA-0397, ASTA-0407, ASSM-0464, ASSM-0465, ASSM-0466, ASSM-0467, ASSM-0468, ASSM-0469, ASSM-0491, ASSM-0492, ASSM-0493, ASSM-0494, ASSM-0495.
- LOT
- ASSH-0239
- LOT
- ASSH-0240
- LOT
- ASSH-0241
- LOT
- ASSH-0242
- LOT
- ASSH-0243
- LOT
- ASSH-0244
- LOT
- ASSH-0245
- LOT
- ASSH-0246
- LOT
- ASSH-0247
- LOT
- ASSH-0248
- LOT
- ASSH-0249
- LOT
- ASSH-0250
- LOT
- ASSH-0251
- LOT
- ASSH-0252
- LOT
- ASSH-0253
- LOT
- ASSH-0254
- LOT
- ASSL-0355
- LOT
- ASSL-0356
- LOT
- ASSL-0357
- LOT
- ASSL-0358
- LOT
- ASSL-0359
- LOT
- ASSL-0360
- LOT
- ASSL-0361
- LOT
- ASSM-0464
- LOT
- ASSM-0465
- LOT
- ASSM-0466
- LOT
- ASSM-0467
- LOT
- ASSM-0468
- LOT
- ASSM-0469
- LOT
- ASSM-0491
- LOT
- ASSM-0492
- LOT
- ASSM-0493
- LOT
- ASSM-0494
- LOT
- ASSM-0495.
- LOT
- ASTA-0271
- LOT
- ASTA-0272
- LOT
- ASTA-0273
- LOT
- ASTA-0274
- LOT
- ASTA-0275
- LOT
- ASTA-0276
- LOT
- ASTA-0308
- LOT
- ASTA-0310
- LOT
- ASTA-0312
- LOT
- ASTA-0352
- LOT
- ASTA-0354
- LOT
- ASTA-0364
- LOT
- ASTA-0395
- LOT
- ASTA-0396
- LOT
- ASTA-0397
- LOT
- ASTA-0407
- LOT
- Model Number: 8621600. UDI-DI Number: 04048675556183. Serial Numbers: ASSL-0354
- RECALL-NUMBER
- Z-2208-2026
2. Is my exact product affected?
Compare every printed identifier. A matching value can indicate that your product is included.
3. What is the hazard?
The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.
4. What should I do now?
Follow the FDA recall notice and contact the recalling company for current instructions.
5. Where was it sold or distributed?
Arkansas, Arizona, Colorado, Florida, Massachusetts, Minnesota, North Dakota, New York, Pennsylvania, South Dakota, Wisconsin
View source evidence for state distribution
- Arkansas: US distribution in WI, AR, MN, WI, CO, MA, PA, AZ, FL, NY, SD, ND. International distribution to: Algeria, Argentina, Australia, Austria, Azerbaijan, Bangladesh, Belarus, Belgium, Benin, Brazil, Bulgaria, Canada, Chili, China, Colombia, Croatia, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, French Polynesia, Gabon, Germany, Ghana, Greece, Greenland, Hong Kong, Hungary, India, Indonesia, Iraq, Ireland, Italy, Israel, Japan, Jordan, Kosovo, Kuwait, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Malaysia, Martinique, Mauritius, Mexico, Morocco, Mozambique, Namibia, Nepal, Netherlands, Norway, Pakistan, Palestine, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Rwanda, Saudi Arabia, Senegal, Serbia, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Kingdom, Uruguay, United Arab Emirates, Uzbekistan, Venezuela, Vietnam, Yemen
- Arizona: US distribution in WI, AR, MN, WI, CO, MA, PA, AZ, FL, NY, SD, ND. International distribution to: Algeria, Argentina, Australia, Austria, Azerbaijan, Bangladesh, Belarus, Belgium, Benin, Brazil, Bulgaria, Canada, Chili, China, Colombia, Croatia, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, French Polynesia, Gabon, Germany, Ghana, Greece, Greenland, Hong Kong, Hungary, India, Indonesia, Iraq, Ireland, Italy, Israel, Japan, Jordan, Kosovo, Kuwait, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Malaysia, Martinique, Mauritius, Mexico, Morocco, Mozambique, Namibia, Nepal, Netherlands, Norway, Pakistan, Palestine, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Rwanda, Saudi Arabia, Senegal, Serbia, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Kingdom, Uruguay, United Arab Emirates, Uzbekistan, Venezuela, Vietnam, Yemen
- Colorado: US distribution in WI, AR, MN, WI, CO, MA, PA, AZ, FL, NY, SD, ND. International distribution to: Algeria, Argentina, Australia, Austria, Azerbaijan, Bangladesh, Belarus, Belgium, Benin, Brazil, Bulgaria, Canada, Chili, China, Colombia, Croatia, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, French Polynesia, Gabon, Germany, Ghana, Greece, Greenland, Hong Kong, Hungary, India, Indonesia, Iraq, Ireland, Italy, Israel, Japan, Jordan, Kosovo, Kuwait, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Malaysia, Martinique, Mauritius, Mexico, Morocco, Mozambique, Namibia, Nepal, Netherlands, Norway, Pakistan, Palestine, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Rwanda, Saudi Arabia, Senegal, Serbia, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Kingdom, Uruguay, United Arab Emirates, Uzbekistan, Venezuela, Vietnam, Yemen
- Florida: US distribution in WI, AR, MN, WI, CO, MA, PA, AZ, FL, NY, SD, ND. International distribution to: Algeria, Argentina, Australia, Austria, Azerbaijan, Bangladesh, Belarus, Belgium, Benin, Brazil, Bulgaria, Canada, Chili, China, Colombia, Croatia, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, French Polynesia, Gabon, Germany, Ghana, Greece, Greenland, Hong Kong, Hungary, India, Indonesia, Iraq, Ireland, Italy, Israel, Japan, Jordan, Kosovo, Kuwait, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Malaysia, Martinique, Mauritius, Mexico, Morocco, Mozambique, Namibia, Nepal, Netherlands, Norway, Pakistan, Palestine, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Rwanda, Saudi Arabia, Senegal, Serbia, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Kingdom, Uruguay, United Arab Emirates, Uzbekistan, Venezuela, Vietnam, Yemen
- Massachusetts: US distribution in WI, AR, MN, WI, CO, MA, PA, AZ, FL, NY, SD, ND. International distribution to: Algeria, Argentina, Australia, Austria, Azerbaijan, Bangladesh, Belarus, Belgium, Benin, Brazil, Bulgaria, Canada, Chili, China, Colombia, Croatia, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, French Polynesia, Gabon, Germany, Ghana, Greece, Greenland, Hong Kong, Hungary, India, Indonesia, Iraq, Ireland, Italy, Israel, Japan, Jordan, Kosovo, Kuwait, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Malaysia, Martinique, Mauritius, Mexico, Morocco, Mozambique, Namibia, Nepal, Netherlands, Norway, Pakistan, Palestine, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Rwanda, Saudi Arabia, Senegal, Serbia, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Kingdom, Uruguay, United Arab Emirates, Uzbekistan, Venezuela, Vietnam, Yemen
- Minnesota: US distribution in WI, AR, MN, WI, CO, MA, PA, AZ, FL, NY, SD, ND. International distribution to: Algeria, Argentina, Australia, Austria, Azerbaijan, Bangladesh, Belarus, Belgium, Benin, Brazil, Bulgaria, Canada, Chili, China, Colombia, Croatia, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, French Polynesia, Gabon, Germany, Ghana, Greece, Greenland, Hong Kong, Hungary, India, Indonesia, Iraq, Ireland, Italy, Israel, Japan, Jordan, Kosovo, Kuwait, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Malaysia, Martinique, Mauritius, Mexico, Morocco, Mozambique, Namibia, Nepal, Netherlands, Norway, Pakistan, Palestine, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Rwanda, Saudi Arabia, Senegal, Serbia, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Kingdom, Uruguay, United Arab Emirates, Uzbekistan, Venezuela, Vietnam, Yemen
- North Dakota: US distribution in WI, AR, MN, WI, CO, MA, PA, AZ, FL, NY, SD, ND. International distribution to: Algeria, Argentina, Australia, Austria, Azerbaijan, Bangladesh, Belarus, Belgium, Benin, Brazil, Bulgaria, Canada, Chili, China, Colombia, Croatia, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, French Polynesia, Gabon, Germany, Ghana, Greece, Greenland, Hong Kong, Hungary, India, Indonesia, Iraq, Ireland, Italy, Israel, Japan, Jordan, Kosovo, Kuwait, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Malaysia, Martinique, Mauritius, Mexico, Morocco, Mozambique, Namibia, Nepal, Netherlands, Norway, Pakistan, Palestine, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Rwanda, Saudi Arabia, Senegal, Serbia, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Kingdom, Uruguay, United Arab Emirates, Uzbekistan, Venezuela, Vietnam, Yemen
- New York: US distribution in WI, AR, MN, WI, CO, MA, PA, AZ, FL, NY, SD, ND. International distribution to: Algeria, Argentina, Australia, Austria, Azerbaijan, Bangladesh, Belarus, Belgium, Benin, Brazil, Bulgaria, Canada, Chili, China, Colombia, Croatia, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, French Polynesia, Gabon, Germany, Ghana, Greece, Greenland, Hong Kong, Hungary, India, Indonesia, Iraq, Ireland, Italy, Israel, Japan, Jordan, Kosovo, Kuwait, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Malaysia, Martinique, Mauritius, Mexico, Morocco, Mozambique, Namibia, Nepal, Netherlands, Norway, Pakistan, Palestine, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Rwanda, Saudi Arabia, Senegal, Serbia, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Kingdom, Uruguay, United Arab Emirates, Uzbekistan, Venezuela, Vietnam, Yemen
- Pennsylvania: US distribution in WI, AR, MN, WI, CO, MA, PA, AZ, FL, NY, SD, ND. International distribution to: Algeria, Argentina, Australia, Austria, Azerbaijan, Bangladesh, Belarus, Belgium, Benin, Brazil, Bulgaria, Canada, Chili, China, Colombia, Croatia, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, French Polynesia, Gabon, Germany, Ghana, Greece, Greenland, Hong Kong, Hungary, India, Indonesia, Iraq, Ireland, Italy, Israel, Japan, Jordan, Kosovo, Kuwait, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Malaysia, Martinique, Mauritius, Mexico, Morocco, Mozambique, Namibia, Nepal, Netherlands, Norway, Pakistan, Palestine, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Rwanda, Saudi Arabia, Senegal, Serbia, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Kingdom, Uruguay, United Arab Emirates, Uzbekistan, Venezuela, Vietnam, Yemen
- South Dakota: US distribution in WI, AR, MN, WI, CO, MA, PA, AZ, FL, NY, SD, ND. International distribution to: Algeria, Argentina, Australia, Austria, Azerbaijan, Bangladesh, Belarus, Belgium, Benin, Brazil, Bulgaria, Canada, Chili, China, Colombia, Croatia, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, French Polynesia, Gabon, Germany, Ghana, Greece, Greenland, Hong Kong, Hungary, India, Indonesia, Iraq, Ireland, Italy, Israel, Japan, Jordan, Kosovo, Kuwait, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Malaysia, Martinique, Mauritius, Mexico, Morocco, Mozambique, Namibia, Nepal, Netherlands, Norway, Pakistan, Palestine, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Rwanda, Saudi Arabia, Senegal, Serbia, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Kingdom, Uruguay, United Arab Emirates, Uzbekistan, Venezuela, Vietnam, Yemen
- Wisconsin: US distribution in WI, AR, MN, WI, CO, MA, PA, AZ, FL, NY, SD, ND. International distribution to: Algeria, Argentina, Australia, Austria, Azerbaijan, Bangladesh, Belarus, Belgium, Benin, Brazil, Bulgaria, Canada, Chili, China, Colombia, Croatia, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, French Polynesia, Gabon, Germany, Ghana, Greece, Greenland, Hong Kong, Hungary, India, Indonesia, Iraq, Ireland, Italy, Israel, Japan, Jordan, Kosovo, Kuwait, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Malaysia, Martinique, Mauritius, Mexico, Morocco, Mozambique, Namibia, Nepal, Netherlands, Norway, Pakistan, Palestine, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Rwanda, Saudi Arabia, Senegal, Serbia, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Kingdom, Uruguay, United Arab Emirates, Uzbekistan, Venezuela, Vietnam, Yemen
6. Were injuries or illnesses reported?
No separate injury or illness statement was present in the normalized record. Check the official source for the latest report.
7. What remedy is available?
Follow the FDA recall notice and contact the recalling company for current instructions.
8. Is the recall active or closed?
The source status is Ongoing. The Recall Guy's urgency label is urgent, which is a separate deterministic site label.
9. When was the information checked?
Last checked .
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10. Where is the official source?
Open the official FDA Device source
The Recall Guy normalizes public source data for easier checking. Source agencies remain authoritative. Confirm identifiers and instructions at the official source.