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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 Ventilator Failure

Agency Publication Date: December 18, 2024
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Summary

Draeger Medical, Inc. has recalled approximately 305 Atlan A300 and A300XL anesthesia workstations because the ventilator system may fail. These workstations are used to provide anesthesia and breathing support to adults, children, and infants during medical procedures. The device may signal a failure before it is used or stop providing mechanical ventilation during use. No injuries or incidents have been reported in connection with this issue, and no units were imported into the United States.

Risk

If the workstation's piston ventilator fails, it can stop providing mechanical breathing support to the patient, which could lead to serious medical complications during anesthesia.

What You Should Do

  1. The recalled products are Atlan A300 and A300XL anesthesia workstations used for medical procedures involving adults, children, and infants.
  2. To identify if your device is affected, check the model and serial number printed on the device label. This recall includes model numbers 8211300 and 8621400. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.
  4. Call the FDA: 1-888-463-6332 (1-888-INFO-FDA) for additional questions regarding this recall.

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 A300 Anesthesia Workstation
Model / REF:
8211300
Serial Numbers (249):
ASTA-0314
ASTA-0315
ASTA-0325
ASTA-0338
ASTA-0340
ASTA-0384
ASTA-0411
ASTA-0425
ASTB-0002
ASTB-0010
ASTB-0018
ASTB-0151
ASTB-0160
ASTB-0161
ASTB-0165
ASTB-0175
ASTB-0176
ASTB-0177
ASTB-0178
ASTB-0179
ASTB-0180
ASTB-0181
ASTB-0182
ASTB-0214
ASTB-0215
ASTB-0218
ASTB-0232
ASTB-0233
ASTB-0234
ASTB-0235
ASTB-0236
ASTB-0248
ASTB-0249
ASTB-0250
ASTB-0262
ASTB-0263
ASTB-0264
ASTB-0265
ASTB-0266
ASTB-0276
ASTB-0277
ASTB-0278
ASTB-0279
ASTB-0280
ASTC-0008
ASTC-0025
ASTC-0036
ASTC-0037
ASTC-0038
ASTC-0039
UDI:
04048675556343

The Atlan is an anesthesia workstation intended for use in anesthetizing adults, pediatrics, and neonates. Distributed only outside of the United States (OUS).

Product: Atlan A300XL Anesthesia Workstation
Model / REF:
8621400
Serial Numbers:
ASTB-0051
ASTB-0053
ASTB-0054
ASTB-0055
ASTB-0063
ASTB-0065
ASTB-0093
ASTB-0162
ASTE-0219
ASTE-0220
ASTE-0221
ASTE-0222
ASTE-0377
ASTF-0472
ASTF-0473
ASTH-0005
ASTH-0006
ASTH-0026
ASTH-0027
ASTH-0047
ASTH-0186
ASTH-0223
ASTH-0224
ASTH-0401
ASTJ-0170
UDI:
04048675556343

The Atlan is an anesthesia workstation intended for use in anesthetizing adults, pediatrics, and neonates. Distributed only outside of the United States (OUS).

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95759
Status: Active
Manufacturer: Draeger Medical, Inc.
Sold By: Draegerwerk Ag and Co. KGaA
Manufactured In: United States
Units Affected: 2 products (280 units (OUS only); 25 units (OUS Only))

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.