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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

Baxter Healthcare Corporation: Life2000 Ventilator Systems Recalled for Battery Charging Failure

Agency Publication Date: June 26, 2024
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Summary

Baxter Healthcare Corporation is recalling 2,510 units of the Life2000 Ventilator and Life2000 Ventilator Systems because the battery charger dongle may be damaged. This defect can cause the ventilator to fail to charge or have intermittent charging, which prevents the device's internal battery from working properly. These systems were distributed nationwide across the United States. Consumers should check their specific serial numbers and product codes to see if their life-support equipment is affected.

Risk

If the battery charger dongle is damaged, the ventilator's internal battery cannot charge, which may cause the device to lose power during use. This failure can lead to a sudden interruption in respiratory therapy, potentially resulting in serious injury or death for patients who rely on the ventilator for breathing support.

What You Should Do

  1. Check your device for Product Codes MS-01-0118, BT-20-0002, BT-20-0002A, or BT-20-0002AP.
  2. Verify your specific serial number against the list of 2,510 affected units, which includes sequences such as 123300001188 through 123500000070, and various alphanumeric IDs like L1903102-018 or L2007004-002.
  3. Inspect the battery charger dongle for any signs of physical damage that might cause intermittent or failed charging behavior.
  4. Immediately contact your healthcare provider or Baxter Healthcare Corporation to discuss the status of your ventilator and receive further instructions on how to ensure your device remains operational.
  5. If you experience any issues with the device charging, ensure you have a backup ventilation method available as instructed by your healthcare professional.
  6. Contact Baxter Healthcare Corporation at their headquarters at 1 Baxter Pkwy, Deerfield, Illinois, 60015-4625, for specific technical support or to initiate a remedy.
  7. For additional questions or to report an incident, call the FDA at 1-888-463-6332 (1-888-INFO-FDA).

Your Remedy Options

📋Other Action

Manufacturer-initiated safety corrective action due to battery dongle failure.

How to: Contact your healthcare provider or the manufacturer (Baxter Healthcare Corporation) for further instructions and potential repair/replacement options for the battery charger dongle.

Affected Products

Product: Life2000 Ventilator
Model / REF:
MS-01-0118
Lot Numbers:
UDI: 00887761978089
Product: Life2000 Ventilator System (BT-20-0002)
Model / REF:
BT-20-0002
Lot Numbers (1317):
123300001188
123300001189
123300001190
123300001191
123300001192
123300001193
123300001194
123300001195
123300001196
123300001197
123300001220
123300001221
123300001222
123300001223
123300001224
123300001225
123300001227
123300001292
123300001293
123300001416
123300001418
123300001419
123300001420
123300001421
123300001423
123300001424
123300001425
123300001426
123300001428
123300001612
123300001614
123300001615
123300001616
123300001617
123300001618
123300001619
123300001620
123300001621
123300001669
123300001670
123300001671
123300001672
123300001673
123300001674
123300001675
123300001676
123300001677
123300001678
123300001683
123300001684
Product: Life2000 Ventilator System (BT-20-0002A)
Model / REF:
BT-20-0002A
Lot Numbers (1192):
120340001045
121520001264
122010000059
123230001066
122340001746
123300001613
122010000025
123230001454
121410001196
123350001076
122410000847
122410001398
120460001869
122090001433
123180000698
123350001138
L1903102-018
122110001037
123230000608
123130002179
121020000290
123320000737
121520000113
122010000786
122340001208
122010000023
123220000343
123160002190
L2003015-024
L1912025-019
120390000088
123350001008
123140000123
122110001284
123300001422
120450001336
123130002281
120470000420
L2006020-502
123340001927
123350001068
120390000106
122340000204
120470000127
122090001410
122270001329
121520001271
122410000240
123140000129
123340001696
Product: Life2000 Ventilator System (BT-20-0002AP)
Model / REF:
BT-20-0002AP
Lot Numbers:
120380001667

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94701
Status: Active
Manufacturer: Baxter Healthcare Corporation
Sold By: Authorized Medical Device Distributors; Healthcare Providers
Manufactured In: United States
Units Affected: 2,510 units
Distributed To: Nationwide
Agency Last Updated: July 17, 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

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 · FDA Press Release · 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.