RecallRadar

FDA Device recall Z-2207-2026

Atlan A350

On 2026-06-10 the FDA classified a Class I recall of Atlan A350 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

AgencyFDA Device
Recall numberZ-2207-2026
ClassificationClass I
Statusongoing
Initiated2026-05-07
Published2026-06-10
Last updated2026-09-13 11:58 UTC
CompanyDraeger
DistributionAR, AZ, CO, FL, MA, MN, ND, NY, PA, SD, WI

Product

Atlan A350. Model Number: 8211500. 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: 8211500. UDI-DI Number: 04048675556176.Serial Numbers: ASSL-0347, ASSL-0348, ASSL-0351, ASSH-0220, ASSH-0…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.

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-2207-2026%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.