FDA Device Recall Z-2617-2025
Draeger, Inc. · Telford, PA
Class I — life-threatening Ongoing
Device
Brand Name: Atlan Product Name: Atlan A350XL Model/Catalog Number: 8621600 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
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.
Recall record
- Recall number
Z-2617-2025- Classification
- Class I
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- 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.
- Recall initiated
- 2025-09-09
- Classified by FDA Center
- 2025-10-01
- FDA published
- 2025-10-08
- Recalling firm
- Draeger, Inc.
- Firm location
- Telford, PA
Operational response
A Class I device recall indicates a strong likelihood of serious adverse health consequence or death from continued use. Identify affected units by serial number, lot, or GTIN against your inventory and against implanted-device patient registry. Pull affected inventory from active use immediately. For implanted devices, follow the recalling firm’s patient-notification protocol; in most cases this requires informing affected patients and their treating physicians directly.
For the official FDA enforcement record, see FDA's Recall Search.