CLASS I ONGOING Device recall · Reported 10 Jun 2026 · FDA Enforcement Report

Atlan A350 recalled by Draeger

Draeger is recalling Atlan A350, distributed in 11 states. The recall was initiated on 7 May 2026 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesModel 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.

Quantity recalled3,515 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2207-2026
FDA event ID: 98914
Recalling firm: Draeger, Telford, PA
Classification: Class I
Status: Ongoing
Recall initiated: 7 May 2026
FDA classified: 4 Jun 2026
Reported: 10 Jun 2026
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

7 May 2026	Recall initiated by company
4 Jun 2026	Classified by FDA	+28 days
10 Jun 2026	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

Atlan A350. Model Number: 8211500. anesthesia workstation

Where it was distributed

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

Arkansas Arizona Colorado Florida Massachusetts Minnesota North Dakota New York Pennsylvania South Dakota Wisconsin

Questions about this recall

Why was it recalled?

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

Which lots are affected?

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.

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 98914

This product is part of a recall event; the main page for the event is Atlan A350XL recalled by Draeger.

Reported	Class	Recall	Company	Reason	Where
10 Jun 2026	CLASS I	Atlan A350XL recalled by Draeger	Draeger	Device Malfunction	11 states

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