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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Critical RiskFDA Device
Medical Devices/Surgical Equipment

Draeger Atlan Anesthesia Workstations Recalled for Ventilation Failure

Agency Publication Date: October 1, 2025
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Summary

Draeger, Inc. is recalling 753 Atlan A350 and Atlan A350XL anesthesia workstations because the devices may experience a failure of the piston ventilator or mechanical ventilation system. These workstations are used in clinical settings to provide anesthesia and mechanical ventilation for adults, children, and infants during surgery. The recall affects units that have either shown failures before use or suffered ventilation failure during use, which could prevent the device from delivering necessary breathing support to the patient.

Risk

A failure of the mechanical ventilation system while a patient is under anesthesia can lead to a sudden loss of respiratory support. This poses a critical risk of oxygen deprivation (hypoxia) and respiratory distress, which can result in serious injury or death.

What You Should Do

  1. The recalled products are Draeger Atlan A350 (model 8211500) and Atlan A350XL (model 8621600) anesthesia workstations.
  2. Identify if your device is affected by checking the model number and serial number on the device label. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled device immediately.
  4. Contact Draeger, Inc. or your equipment distributor to arrange for the return, replacement, or correction of the device.
  5. Call the FDA Consumer Complaint hotline at 1-888-463-6332 if you have additional questions or wish to report an incident.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Atlan A350 Anesthesia Workstation
Model / REF:
8211500
Serial Numbers (520):
ASTB-0181
ASTC-0005
ASTC-0006
ASTC-0007
ASTD-0244
ASTD-0259
ASTE-0180
ASTE-0254
ASTE-0255
ASTH-0083
ASTH-0464
ASUA-0479
ASUA-0482
ASUB-0012
ASUB-0013
ASUB-0015
ASUB-0017
ASUB-0018
ASUB-0292
ASUC-0065
ASUC-0084
ASUC-0085
ASUC-0086
ASUC-0087
ASUC-0088
ASUC-0090
ASUC-0091
ASUC-0092
ASUC-0096
ASUC-0097
ASUC-0099
ASUC-0100
ASUC-0101
ASUC-0102
ASUC-0103
ASUC-0104
ASUC-0105
ASUC-0107
ASUC-0108
ASUC-0109
ASUC-0110
ASUC-0111
ASUC-0112
ASUC-0113
ASUC-0116
ASUC-0117
ASUC-0118
ASUC-0119
ASUC-0120
ASUC-0121
UDI:
04048675556176

Intended for use in anesthetizing adults, pediatrics, and neonates.

Product: Atlan A350XL Anesthesia Workstation
Model / REF:
8621600
Serial Numbers (217):
ASTA-0307
ASTA-0309
ASTA-0311
ASTA-0349
ASTA-0350
ASTA-0409
ASTB-0048
ASTC-0244
ASTC-0245
ASTD-0008
ASTD-0009
ASTD-0010
ASTD-0011
ASTD-0013
ASTD-0014
ASTD-0212
ASTD-0239
ASTH-0307
ASTH-0308
ASTH-0309
ASTH-0310
ASTH-0311
ASTH-0332
ASTH-0333
ASTH-0334
ASTH-0335
ASTH-0336
ASTH-0383
ASTH-0384
ASTJ-0014
ASUA-0469
ASUA-0483
ASUA-0484
ASUA-0486
ASUA-0488
ASUB-0093
ASUB-0169
ASUB-0170
ASUB-0171
ASUB-0172
ASUB-0173
ASUB-0174
ASUB-0175
ASUB-0176
ASUB-0183
ASUB-0184
ASUB-0185
ASUB-0186
ASUB-0187
ASUB-0215
UDI:
04048675556183

Intended for use in anesthetizing adults, pediatrics, and neonates.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97525
Status: Active
Manufacturer: Draeger, Inc.
Sold By: Authorized Medical Device Distributors; Direct Hospital Sales
Manufactured In: United States, Germany
Units Affected: 2 products (530; 223)
Distributed To: Alabama, Arizona, California, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Minnesota, Missouri, North Carolina, Nebraska, New Mexico, Nevada, New York, Ohio, Pennsylvania, Texas, Utah, Virginia, Wisconsin

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.