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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

Atlan Anesthesia Workstations Recalled for Ventilation Failure

Agency Publication Date: November 13, 2024
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Summary

Draeger Medical, Inc. has recalled approximately 1,947 Atlan A350 and A350XL anesthesia workstations because the piston ventilator may fail to start before use or may fail during mechanical ventilation. These devices are used in hospitals and surgical centers to provide anesthesia and breathing support to patients during medical procedures. While no injuries have been reported, a failure of the ventilator can result in a loss of breathing support, requiring immediate intervention by medical staff to manually ventilate the patient. The recall affects units sold nationwide across 21 states and distributed internationally.

Risk

The mechanical ventilator in the anesthesia workstation may stop working or fail to initiate, potentially leaving a patient without mechanical breathing assistance during a surgical procedure. If this occurs, medical staff must immediately switch to manual ventilation to prevent respiratory distress or injury to the patient.

What You Should Do

  1. This recall involves Draeger Atlan A350 (Model 8211500) and Atlan A350XL (Model 8621600) anesthesia workstations.
  2. Identify affected units by checking the Model/Catalog number and the unique Serial Number located on the device identification label. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled anesthesia workstations immediately.
  4. Contact Draeger Medical, Inc. or your authorized medical device distributor to arrange for a return, replacement, or repair of the affected workstation.
  5. For additional questions or to report a problem with the device, call the FDA at 1-888-463-6332.

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 (1461):
ASTB-0038
ASTB-0039
ASTB-0146
ASTB-0147
ASTB-0148
ASTB-0281
ASTB-0282
ASTB-0283
ASTB-0300
ASTB-0301
ASTB-0302
ASTB-0303
ASTB-0312
ASTB-0313
ASTB-0314
ASTB-0315
ASTB-0316
ASTC-0005
ASTC-0094
ASTC-0095
ASTC-0190
ASTC-0191
ASTD-0029
ASTD-0030
ASTD-0031
ASTD-0032
ASTD-0033
ASTD-0034
ASTD-0035
ASTD-0036
ASTD-0037
ASTD-0038
ASTD-0039
ASTD-0040
ASTD-0041
ASTD-0042
ASTD-0043
ASTD-0044
ASTD-0045
ASTD-0046
ASTD-0057
ASTD-0136
ASTD-0137
ASTD-0138
ASTD-0139
ASTD-0140
ASTD-0141
ASTD-0142
ASTD-0143
ASTD-0148
UDI:
04048675556176

Quantity affected: 1,492 units (139 units US, 1,353 OUS).

Product: Atlan A350XL Anesthesia Workstation
Model / REF:
8621600
Serial Numbers (453):
ASTA-0307
ASTA-0309
ASTA-0311
ASTA-0349
ASTA-0350
ASTA-0351
ASTA-0353
ASTA-0363
ASTA-0365
ASTA-0394
ASTA-0408
ASTA-0409
ASTB-0048
ASTB-0286
ASTB-0287
ASTB-0288
ASTB-0289
ASTB-0290
ASTB-0291
ASTB-0304
ASTB-0305
ASTB-0306
ASTB-0307
ASTB-0308
ASTB-0309
ASTB-0317
ASTB-0318
ASTB-0319
ASTB-0320
ASTB-0321
ASTB-0322
ASTC-0006
ASTC-0007
ASTC-0068
ASTC-0069
ASTC-0070
ASTC-0082
ASTC-0083
ASTC-0099
ASTC-0100
ASTC-0101
ASTC-0105
ASTC-0106
ASTC-0107
ASTC-0108
ASTC-0109
ASTC-0118
ASTC-0119
ASTC-0136
ASTC-0137
UDI:
04048675556183

Quantity affected: 455 units (310 units US, 145 OUS).

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95561
Status: Active
Manufacturer: Draeger Medical, Inc.
Sold By: Hospital suppliers; Medical device distributors
Manufactured In: United States
Units Affected: 2 products (1,492 units (139 units US, 1,353 OUS); 455 units (310 units US, 145 OUS))
Distributed To: Alabama, Arizona, California, Florida, Georgia, Iowa, Illinois, Kentucky, Massachusetts, Maine, North Dakota, Nebraska, New Hampshire, New Jersey, New York, Ohio, Pennsylvania, Tennessee, Texas, Wisconsin, Wyoming
Agency Last Updated: November 22, 2024

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

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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.