Severity
Critical
CriticalClass IOngoing
FDA Devices recall · Reported December 25, 2024
Brand Name: Atlan Product Name: Atlan A300XL Model/Catalog Number: 8621400 The Atlan is an anesthesia workstation intended for use in anesthetizing adults, pediatrics, and neonates.
The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Draeger Medical, Inc. recalled Brand Name: Atlan Product Name: Atlan A300XL Model/Catalog Number: 8621400 The At… - a critical-severity action.
Brand Name: Atlan Product Name: Atlan A300XL Model/Catalog Number: 8621400 The At… was recalled by Draeger Medical, Inc. in December 25, 2024. Reason: The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a…. Check the official notice for the remedy. Verify recall #Z-0668-2025 with the FDA Devices before acting.
The recall
Draeger Medical, Inc. issued this critical-severity FDA Devices recall-The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a….
- Critical
- severity level
- 25 units
- affected scope
- Class I
- classification
- December 25, 2024
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0668-2025 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0668-2025) was formally reported on December 25, 2024, with the manufacturer initiating the action on October 15, 2024. It is classified under Critical severity (Class I), with a current status of Ongoing. Draeger Medical, Inc. is listed as the recalling firm, operating out of Telford, PA. Federal records list the affected scope as 25 units (OUS Only).
The documented reason for this 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. Distribution data in the federal record shows the product reached: No Atlan A300 or A300XL devices were imported into the US. Devices were direct shipped from Draegerwerk Ag and Co. KGaA to the following countries: Argentina, Australia, Austria, Azerbaijan, Bahrain, Belgium, Brazil, Bu…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
25 units (OUS Only)
Related Recalls
6
3 from same agency
Product description
Brand Name: Atlan Product Name: Atlan A300XL Model/Catalog Number: 8621400 The Atlan is an anesthesia workstation intended for use in anesthetizing adults, pediatrics, and neonates.
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Ongoing |
| Recall number | Z-0668-2025 |
| Date reported | December 25, 2024 |
| Date initiated | October 15, 2024 |
| Recalling firm | Draeger Medical, Inc. |
| Firm location | Telford, PA |
| Affected scope | 25 units (OUS Only) |
| Distribution | No Atlan A300 or A300XL devices were imported into the US. Devices were direct shipped from Draegerwerk Ag and Co. KGaA to the following countries: Argentina, Australia, Austria, Azerbaijan, Bahrain, Belgium, Brazil, Bulgaria, Cambodia, Ca… |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0668-2025) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
Brand Name: Atlan Product Name: Atlan A300XL Model/Catalog Number: 8621400 The Atlan is an anesthesia workstation intended for use in anesthetizing adults, pediatrics, and neonates.. Recalled by Draeger Medical, Inc.. Units affected: 25 units (OUS Only).
Why was this product 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 agency issued this recall? ▼
This recall was issued by the FDA Devices on December 25, 2024. Severity: Critical. Recall number: Z-0668-2025.
Where was the recalled product distributed? ▼
Distribution: No Atlan A300 or A300XL devices were imported into the US. Devices were direct shipped from Draegerwerk Ag and Co. KGaA to the following countries: Argentina, Australia, Austria, Azerbaijan, Bahrain, Belgium, Brazil, Bulgaria, Cambodia, Canada, Chili, China, Colombia, Croatia, Czech Republic, Egypt, El Salvador, Estonia, Finland, France, Germany, Greece, Hungary, India, Indonesia, Ireland, Italy, Japan, Jordan, Kazakhstan, Kenya, Latvia, Malaysia, Mauritius, Mexico, Morocco, Namibia, Nepal, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Reunion, Romania, Russian Federation, Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Kingdom, Uruguay, United Arab Emirates, and Vietnam..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0668-2025) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported December 25, 2024. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.