Recall Z-2208-2026— Draeger, Inc.

Name: FDA recall Z-2208-2026
Creator: U.S. Food and Drug Administration
Published: 2026-05-07

Class I · Ongoing

Class I FDA medical device recall by Draeger, Inc., initiated 2026-05-07. It names one FDA 510(k) clearance: K230931. 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..

Recalling firm: Draeger, Inc.
Classification: Class I
Status: Ongoing
Initiated: 2026-05-07
Firm location: Telford, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K230931 — AtlanDrägerwerk AG Co. Kgaa·cleared 2023-07-23

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Atlan A350XL. Model Number: 8621600. anesthesia workstation

Reason for recall

The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.

Data sourced from openFDA. This site is unofficial and independent of the FDA.