# FDA recall Z-0668-2025

> **Draeger Medical, Inc.** · Class I · device recall initiated 2024-10-15.

## Product

Brand Name: Atlan   Product Name: Atlan A300XL   Model/Catalog Number: 8621400     The Atlan is an anesthesia workstation intended for use in anesthetizing adults, pediatrics, and neonates.

## 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.

## Distribution

No Atlan A300 or A300XL devices were imported into the US. Devices were direct shipped from Draegerwerk Ag and Co. KGaA to the following countries: Argentina, Australia, Austria, Azerbaijan, Bahrain, Belgium, Brazil, Bulgaria, Cambodia, Canada, Chili, China, Colombia, Croatia, Czech Republic, Egypt, El Salvador, Estonia, Finland, France, Germany, Greece, Hungary, India, Indonesia, Ireland, Italy, Japan, Jordan, Kazakhstan, Kenya, Latvia, Malaysia, Mauritius, Mexico, Morocco, Namibia, Nepal, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Reunion, Romania, Russian Federation, Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Kingdom, Uruguay, United Arab Emirates, and Vietnam.

## Key facts

- **Recall number:** Z-0668-2025
- **Recalling firm:** Draeger Medical, Inc.
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-10-15
- **Report date:** 2024-12-25

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Telford, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0668-2025

## Citation

> AI Analytics. FDA recall Z-0668-2025. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-0668-2025. Source: US FDA. Licensed CC0.

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