Draeger, Inc.: Device Recall

Recall #Z-2616-2025 · 09/09/2025

Class I: Dangerous

Recall Details

Recall Number
Z-2616-2025
Classification
Class I
Product Type
Device
Recalling Firm
Draeger, Inc.
Status
Ongoing
Date Initiated
09/09/2025
Location
Telford, PA, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
530

Reason for Recall

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

Product Description

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

Distribution Pattern

Devices were imported from Draegerwerk Ag and Co. KGaA and distributed in the following states: AL, AZ, CA, CT, FL, GA, ID, IL, IN, KS, KY, MA, MN, MO, NC, NE, NM, NV, NY, OH, PA, TX, UT, VA, WI. Devices were direct shipped from Draegerwerk Ag and Co. KGaA to the following countries: Argentina, Australia, Belgium, Brazil, Chili, China, Croatia, Denmark, Ecuador, France, Georgia, Germany, Greece, Hungary, India, Indonesia, Italy, Japan, Jordan, Kuwait, Lithuania, Mexico, Netherlands, Peru, Poland, Romania, Russian Federation, Saudi Arabia, Serbia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom, Vietnam.

Other Recalls by Draeger, Inc.

View all recalls by Draeger, Inc. →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.