Use caution Medical device recall · FDA · Published May 7, 2026

Draeger Atlan A350XL Anesthesia Workstation Recall: Risk of Ventilator Failure

Draeger recalls Atlan A350XL anesthesia workstations with model 8621600 due to potential piston ventilator failure before use or mechanical ventilation failure during use. Affected units have specific serial numbers listed in the recall notice.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-2208-2026Medical device Draeger ›

Use caution until it’s fixed

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

Take action

Contact the company

Recalling firmDraeger, Inc.3135 Quarry Rd · Telford, PA 18969-1042

✎ GovInfoNow plain-language explainer

Draeger is recalling Atlan A350XL anesthesia workstations with model number 8621600 because they may fail before use or during use, risking patient safety. This recall affects healthcare providers who use these workstations in medical settings. Read more at govinfonow.com/recall/49202-draeger-atlan-a350xl-anesthesia-workstation-recall-risk-of-ventilator-failure.

Source Summary by GovInfoNow · govinfonow.com/recall/49202-draeger-atlan-a350xl-anesthesia-workstation-recall-risk-of-ventilator-failure · Updated August 10, 2026 · FDA enforcement record: FDA #Z-2208-2026

Cite this page

“Draeger Atlan A350XL Anesthesia Workstation Recall: Risk of Ventilator Failure.” GovInfoNow, updated August 10, 2026. https://govinfonow.com/recall/49202-draeger-atlan-a350xl-anesthesia-workstation-recall-risk-of-ventilator-failure. Based on FDA recall #Z-2208-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2208-2026%22&limit=1).

The FDA announced on May 7, 2026, that Draeger, Inc. is recalling the Atlan A350XL anesthesia workstation due to potential piston ventilator failures. The agency issued recall number Z-2208-2026 for the Class I voluntary recall.

How to tell if you have it

Brand: Draeger
Product: Atlan A350XL anesthesia workstation
Model Number: 8621600
UDI-DI Number: 04048675556183
Serial Numbers: ASSL-0354, ASSL-0357, ASSL-0360, ASSH-0240, ASSH-0242, ASSH-0243, ASSH-0245, ASSH-0246, ASSH-0247, ASSH-0248, ASSH-0249, ASSH-0250, ASSL-0355, ASSL-0356, ASSL-0358, ASSL-0359, ASSL-0361, ASSH-0239, ASSH-0241, ASSH-0244, ASSH-0251, ASSH-0252, ASSH-0253, ASSH-0254, ASTA-0308, ASTA-0310, ASTA-0312, ASTA-0271, ASTA-0272, ASTA-0273, ASTA-0274, ASTA-0275, ASTA-0276, ASTA-0352, ASTA-0354, ASTA-0364, ASTA-0395, ASTA-0396, ASTA-0397, ASTA-0407, ASSM-0464, ASSM-0465, ASSM-0466, ASSM-0467, ASSM-0468, ASSM-0469, ASSM-0491, ASSM-0492, ASSM-0493, ASSM-0494, ASSM-0495
Units affected: 394

The hazard

According to the FDA, the Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.

Context

GovInfoNow's records show Draeger, Inc. has had 6 other recalls on record since March 12, 2025. Recent similar recalls include the Draeger VentStar Resus Neo recall on September 3, 2026, and the Draeger Vapor 3000 Anesthetic Vaporizer Recall on November 24, 2025. Other recent recalls of similar products include the Baxter Blue Ventilator Adapter Module Recall (February 18, 2026), the Datex-Ohmeda Aisys Anesthesia System Recall (July 30, 2026), and the Philips Allura Xper FD10C Medical System Recall (December 15, 2025).

How to tell if you have this one

Check for model number 8621600 on the Atlan A350XL anesthesia workstation. Affected units have specific serial numbers listed in the recall notice, including ASSL-0354 through ASTA-0407 and other variants.

Brand
Draeger
Category
Medical device

FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class I
Status
Ongoing
Distribution
US distribution in WI, AR, MN, WI, CO, MA, PA, AZ, FL, NY, SD, ND. International distribution to: Algeria, Argentina, Australia, Austria, Azerbaijan, Bangladesh, Belarus, Belgium, Benin, Brazil, Bulgaria, Canada, Chili, China, Colombia, Croatia, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, French Polynesia, Gabon, Germany, Ghana, Greece, Greenland, Hong Kong, Hungary, India, Indonesia, Iraq, Ireland, Italy, Israel, Japan, Jordan, Kosovo, Kuwait, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Malaysia, Martinique, Mauritius, Mexico, Morocco, Mozambique, Namibia, Nepal, Netherlands, Norway, Pakistan, Palestine, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Rwanda, Saudi Arabia, Senegal, Serbia, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Kingdom, Uruguay, United Arab Emirates, Uzbekistan, Venezuela, Vietnam, Yemen

Recall number	Product, codes & lots	Quantity
Z-2207-2026	Atlan A350. Model Number: 8211500. anesthesia workstation; Model Number: 8211500. UDI-DI Number: 04048675556176.Serial Numbers: ASSL-0347, ASSL-0348, ASSL-0351, ASSH-0220, ASSH-0221, ASSH-0224, ASSH-0225, ASSH-0228, ASSH-0229, ASSH-0230, ASSH-0234, ASSH-0235, ASTA-0086, ASSL-0349, ASSL-0350, ASSL-0352, ASSL-0353, ASSH-0222, ASSH-0223, ASSH-0226, ASSH-0227, ASSH-0231, ASSH-0232, ASSH-0233, ASSH-0236, ASSH-0237, ASSH-0238, ASSN-0185, ASSN-0186, ASSN-0187, ASSN-0188, ASSN-0189, ASSN-0190, ASTB-0037, ASTB-0040, ASTA-0087, ASTA-0088, ASSM-0130, ASSM-0131, ASSM-0132.	3,515 units
Z-2208-2026	Atlan A350XL. Model Number: 8621600. anesthesia workstation; Model Number: 8621600. UDI-DI Number: 04048675556183. Serial Numbers: ASSL-0354, ASSL-0357, ASSL-0360, ASSH-0240, ASSH-0242, ASSH-0243, ASSH-0245, ASSH-0246, ASSH-0247, ASSH-0248, ASSH-0249, ASSH-0250, ASSL-0355, ASSL-0356, ASSL-0358, ASSL-0359, ASSL-0361, ASSH-0239, ASSH-0241, ASSH-0244, ASSH-0251, ASSH-0252, ASSH-0253, ASSH-0254, ASTA-0308, ASTA-0310, ASTA-0312, ASTA-0271, ASTA-0272, ASTA-0273, ASTA-0274, ASTA-0275, ASTA-0276, ASTA-0352, ASTA-0354, ASTA-0364, ASTA-0395, ASTA-0396, ASTA-0397, ASTA-0407, ASSM-0464, ASSM-0465, ASSM-0466, ASSM-0467, ASSM-0468, ASSM-0469, ASSM-0491, ASSM-0492, ASSM-0493, ASSM-0494, ASSM-0495.	394 units

Based on the official FDA remedy

What to do — step by step

Check Model Number
Look for model number 8621600 on the anesthesia workstation.
Contact Draeger
Reach out to Draeger for guidance on next steps if you have the affected model.

Where it went and when

Where it was distributed

Distributed in 11 states, and outside the U.S.

FDA distribution: “US distribution in WI, AR, MN, WI, CO, MA, PA, AZ, FL, NY, SD, ND. International distribution to: Algeria, Argentina, Australia, Austria, Azerbaijan, Bangladesh, Belarus, Belgium, Benin, Brazil, Bulgaria, Canada, Chili, China, Colombia,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Arizona, Arkansas, Colorado, Florida, Massachusetts, Minnesota, New York, North Dakota, Pennsylvania, South Dakota, Wisconsin.

Recall timeline

FDA published this recall 34 days after the firm started it.

May 7, 2026Firm started the recall
Jun 4, 2026FDA classified it Class I
Jun 10, 2026Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/49202-draeger-atlan-a350xl-anesthesia-workstation-recall-risk-of-ventilator-failure">Draeger Atlan A350XL Anesthesia Workstation Recall: Risk of Ventilator Failure (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-2208-2026 (May 7, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2208-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 10, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.