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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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Medium RiskFDA Device
Medical Devices/Monitoring Devices

Draegerwerk Ag & Co. Kgaa: Atlan Anesthesia Gas Machines Recalled Due to Battery Failure and Shutdown

Agency Publication Date: February 1, 2024
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Summary

Draegerwerk is recalling 50 Atlan A350 and Atlan A350 XL anesthesia gas machines because an internal backup battery may fail without warning. If the device is being used while unplugged from a wall outlet (AC power), this battery failure can cause the entire machine to shut down unexpectedly. While all 50 units are currently under the direct control of the manufacturer and have not been distributed to US hospitals or end-users, this recall ensures the defective components are addressed before clinical use. These specialized medical devices were manufactured in Germany and imported to the US.

Risk

If the internal backup battery fails while the machine is operating on battery power, the device will shut down immediately. This could lead to a sudden interruption of anesthesia or ventilation support during a medical procedure, potentially resulting in serious patient harm.

What You Should Do

  1. Identify if you have an Atlan A350 (Catalog 8621500) or Atlan A350 XL (Catalog 8621600) anesthesia machine by checking the model name on the device housing.
  2. Check the device for the following Lot numbers: ASSH-0220 through ASSH-0254, or ASSL-0347 through ASSL-0361.
  3. Verify the Unique Device Identifier (UDI-DI) codes: 04048675556176 for the Atlan A350 and 04048675556183 for the Atlan A350 XL.
  4. Contact Draeger, Inc. or your healthcare provider for further instructions and to ensure the device is serviced or replaced before it is put into clinical use.
  5. Contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls for additional information regarding this safety notice.

Your Remedy Options

๐Ÿ“‹Other Action

Manufacturer direct control and correction

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: Atlan A350 Gas Machine for Anesthesia or Analgesia
Model / REF:
8621500
Lot Numbers:
ASSH-0220
ASSH-0221
ASSH-0222
ASSH-0223
ASSH-0224
ASSH-0225
ASSH-0226
ASSH-0227
ASSH-0228
ASSH-0229
ASSH-0230
ASSH-0231
ASSH-0232
ASSH-0233
ASSH-0234
ASSH-0235
ASSH-0236
ASSH-0237
ASSH-0238
ASSH-0239
ASSH-0240
ASSH-0241
ASSH-0242
ASSH-0243
ASSH-0244
ASSH-0245
ASSH-0246
ASSH-0247
ASSH-0248
ASSH-0249
ASSH-0250
ASSH-0251
ASSH-0252
ASSH-0253
ASSH-0254
Product: Atlan A350 XL Gas Machine for Anesthesia or Analgesia
Model / REF:
8621600
Lot Numbers:
ASSL-0347
ASSL-0349
ASSL-0350
ASSL-0351
ASSL-0352
ASSL-0353
ASSL-0354
ASSL-0355
ASSL-0356
ASSL-0357
ASSL-0358
ASSL-0359
ASSL-0360
ASSL-0361

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93544
Status: Active
Manufacturer: Draegerwerk Ag & Co. Kgaa
Sold By: Draeger, Inc.
Manufactured In: Germany
Units Affected: 50 imported to US, not distributed to end users
Distributed To: Nationwide

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.