FDA Device recall Z-2208-2026
Atlan A350XL. Model Number: 8621600. anesthesia workstation
- FDA Device
- Class I
- ongoing
- Published 2026-06-10
On 2026-06-10 the FDA classified a Class I recall of Atlan A350XL. Model Number: 8621600. anesthesia workstation by Draeger, citing the Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2208-2026 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2026-05-07 |
| Published | 2026-06-10 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Draeger |
| Distribution | AR, AZ, CO, FL, MA, MN, ND, NY, PA, SD, WI |
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.
Identifiers
| code_info | Model Number: 8621600. UDI-DI Number: 04048675556183. Serial Numbers: ASSL-0354, ASSL-0357, ASSL-0360, ASSH-0240, ASSH-…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. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2208-2026%22
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