FDA Recall Database: Class I Recall: Atlan A350. Model Number: 8211500. anesthesia workstation by Draeger, Inc.

Key facts

What this classification means

FDA classifies a recall as Class I when there is a reasonable probability that using the recalled product, or being exposed to it, will cause serious adverse health consequences or death. Class I is FDA's most serious recall classification. In this case, the recalling firm is Draeger, Inc. and the affected product is described in FDA's record as: Atlan A350. Model Number: 8211500. anesthesia workstation. FDA's stated reason for the recall is: The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.. The recall is tracked under FDA recall number Z-2207-2026 and carries a status of Ongoing as of the most recent FDA enforcement report. This classification reflects FDA's assessment of the product defect described above, not a prediction about any specific patient outcome. FDA maintains a public enforcement report database so that consumers, physicians, and purchasers can look up the exact product identifiers involved before deciding what to do. Recall status can change while FDA and the recalling firm continue corrective actions, so checking the firm's own notice for the most current guidance is recommended. Adverse events believed to be related to a recalled product can be reported to FDA's MedWatch program, which FDA uses to monitor safety signals after a recall is opened.

What consumers should do

Because FDA has assigned this recall its highest severity classification, anyone who has this product should stop using it immediately, regardless of whether a problem has been noticed yet. Specifically, check whether the product in your possession matches the description on file with FDA -- Atlan A350. Model Number: 8211500. anesthesia workstation -- and the recall number Z-2207-2026. If it matches, stop using or distributing it and contact Draeger, Inc. or the point of purchase for return or replacement instructions. Retailers and distributors holding affected inventory should quarantine it and follow the firm's written recall notice. FDA maintains a public enforcement report database so that consumers, physicians, and purchasers can look up the exact product identifiers involved before deciding what to do.

Draeger, Inc.’s FDA history

Argus HQ has recorded 2 total FDA actions tied to Draeger, Inc.: 0 warning letters, 2 recalls, 0 approval records, and 0 Form 483 inspection citations.

Frequently asked questions

Where can I verify this recall directly with FDA?

The verbatim FDA record is the source of truth for every recall Argus HQ tracks — always confirm against fda.gov before acting.

What was recalled and why?

Draeger, Inc. recalled Atlan A350. Model Number: 8211500. anesthesia workstation. FDA's record states the reason for recall 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.. The recall is logged under FDA recall number Z-2207-2026 with a Class I classification.

How serious is this recall?

FDA classifies a recall as Class I when there is a reasonable probability that using the recalled product, or being exposed to it, will cause serious adverse health consequences or death. Class I is FDA's most serious recall classification.

What should someone who has this product do?

Because FDA has assigned this recall its highest severity classification, anyone who has this product should stop using it immediately, regardless of whether a problem has been noticed yet. Check the product against FDA's description (Atlan A350. Model Number: 8211500. anesthesia workstation) and recall number Z-2207-2026, then follow Draeger, Inc.'s recall instructions.

Related enforcement actions