Recall archive / FDA device enforcement
Atlan A350XL. Model Number: 8621600. anesthesia workstation — FDA record Z-2208-2026
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date May 7, 2026. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Atlan A350XL. Model Number: 8621600. anesthesia workstation
- Reason
- The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.
- Classification
- Class I
- Recalling firm
- Draeger, Inc.
- Quantity
- 394 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-2208-2026
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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. |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
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
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Jun 10, 2026
- Recall initiation date
- May 7, 2026
- Center classification date
- Jun 4, 2026
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.