Z-2207-2026Class I

Atlan A350. Model Number: 8211500. anesthesia workstation

Name: Z-2207-2026 Atlan A350. Model Number: 8211500. anesthesia workstation
Creator: Draeger, Inc.
Published: 2026-05-07
License: https://open.fda.gov/license/

Draeger, Inc. / initiated 2026-05-07 / Open, Classified

FDA source

Draeger, Inc. began a recall of Atlan A350. Model Number: 8211500. anesthesia workstation on 2026-05-07. FDA classified it as Class I and gives the reason as "The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2207-2026
Classification: Class I
Status: Open, Classified
Initiated: 2026-05-07
Posted: 2026-06-04
Recalling firm: Draeger, Inc.
Product: Atlan A350. Model Number: 8211500. anesthesia workstation
Product code: BSZ Gas-Machine, Anesthesia
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.
FDA root cause: Process change control
Action: Draeger notified consignees of the recall update and expansion on about 05/07/2026 via emailed letter titled Urgent Medical Device Correction Update. Consignees were made aware that due to continuous monitoring, Draeger has determined that an additional number of Atlan devices are affected by the issue and they are replacing ventilator motors. Consignees were instructed that a Draeger Service Representative will contact consignees to arrange a date for the ventilator motor assembly replacement, and until the corrective action is implemented, the device may continue to be used with the customary care by only using the device under permanent supervision in line with the Atlan Instructions for Use. If the mechanical ventilation fails, use Man/Spont ventilation mode to ventilate the patient manually as needed. Consignees were also instructed to complete and return the provided Medical Device Correction Return Response Acknowledgment and Receipt Form and if products have been made available to third parties, please forward this Urgent Medical Device Correction notice to them.
Quantity in commerce: 3,515 units
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
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2207-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2207-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-06-10	2026-06-04
Z-2208-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-06-10	2026-06-04

Product code BSZ

K230931Class IIAtlanDrägerwerk AG Co. Kgaa / cleared 2023-07-23

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)