# FDA recall Z-2616-2025

> **Draeger, Inc.** · Class I · device recall initiated 2025-09-09.

## Product

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

## 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.

## 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.

## Key facts

- **Recall number:** Z-2616-2025
- **Recalling firm:** Draeger, Inc.
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-09-09
- **Report date:** 2025-10-08

- **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-2616-2025

## Citation

> AI Analytics. FDA recall Z-2616-2025. Retrieved 2026-09-03 from https://api.ai-analytics.org/recall/Z-2616-2025. Source: US FDA. Licensed CC0.

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