Class I — Serious Health Hazard

Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.

Brand Name: Atlan Product Name: Atlan A350 Model/Catalog Number: 8211500 Recalled by Draeger, Inc. Due to The device either indicated a failure of the...

Date: September 9, 2025
Company: Draeger, Inc.
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Draeger, Inc. directly.

Affected Products

Brand Name: Atlan Product Name: Atlan A350 Model/Catalog Number: 8211500 Software Version: Not applicable Product Description: The Atlan is an anesthesia workstation intended for use in anesthetizing adults, pediatrics, and neonates. The device can be used for mechanical ventilation, manual ventilation, pressure-supported spontaneous breathing, and spontaneous breathing. The device is specified for inhalational anesthesia and/or patient ventilation in accordance with the intended use during surgical or diagnostic interventions Component: Not applicable

Quantity: 530

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed to 25 states: AL, AZ, CA, CT, FL, GA, ID, IL, IN, KS, KY, MA, MN, MO, NE, NV, NM, NY, NC, OH, PA, TX, UT, VA, WI

Affected (25 states)Not affected

About Draeger, Inc.

Draeger, Inc. has 19 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report