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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/Diagnostic Equipment

Baxter Healthcare Corporation: Exactamix Pro 1200 and 2400 Recalled for Software-Related Over-Delivery Risk

Agency Publication Date: February 16, 2024
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Summary

Baxter Healthcare Corporation is recalling 75 Exactamix Pro 1200 and 2400 compounding devices due to a software error in versions 2.0.8 and 2.1.8. This specific software flaw occurs when using the "Use Some Overfill" feature, which can cause the device to deliver redundant amounts of ingredients. The recall affects 8 units of the Pro 1200 model and 67 units of the Pro 2400 model distributed across 22 states. Because these devices are used to prepare clinical nutrition and medications, an over-delivery of ingredients could lead to serious patient harm.

Risk

A software bug triggers the delivery of double the requested overfill volume, leading to potentially dangerous concentrations of ingredients in a patient's prescription. Over-delivery of potent ingredients can cause metabolic imbalances or toxicities, particularly in sensitive patient populations.

What You Should Do

  1. Check your device's model and reference number to see if it is affected: Baxter Exactamix Pro 1200 (REF EXM12DY) or Baxter Exactamix Pro 2400 (REF EXM24DY).
  2. Verify your device's Serial Number and UDI/DI against the recalled list. For Pro 1200 (UDI 05413765588150), affected serials include PLD2314002, PLD2328001, PLD2328004, PLD2328042, PLD2314006, PLD2328002, PLD2328005, and LD2339005.
  3. For Pro 2400 (UDI 05413765588136), check for serial numbers including PLD0019873, PLD2311023, PLD2325014, PLD2339015, PLD0019879, PLD2311029, and others listed in the official recall notice.
  4. Confirm if your device is running software version 2.0.8 or 2.1.8; if so, immediately discontinue use of the 'Use Some Overfill' feature.
  5. Contact Baxter Healthcare Corporation at 1-888-463-6332 or your healthcare provider for further instructions regarding software updates or device repair.
  6. Contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls if you have additional questions.

Your Remedy Options

๐Ÿ“‹Other Action

Manufacturer mitigation for software error

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

Affected Products

Product: Baxter Exactamix Pro 1200, REF EXM12DY
Model / REF:
REF EXM12DY
UPC Codes:
05413765588150
Lot Numbers:
PLD2314002
PLD2328001
PLD2328004
PLD2328042
PLD2314006
PLD2328002
PLD2328005
LD2339005
Product: Baxter Exactamix Pro 2400, REF EXM24DY
Model / REF:
REF EXM24DY
UPC Codes:
05413765588136
Lot Numbers (67):
PLD0019873
PLD2311023
PLD2325014
PLD2339015
PLD0019879
PLD2311029
PLD2325016
PLD2339016
PLD2245007
PLD2311031
PLD2325017
PLD2339017
PLD2303007
PLD2311034
PLD2325018
PLD2339018
PLD2303008
PLD2311036
PLD2325019
PLD2339019
PLD2310013
PLD2325001
PLD2328033
PLD2339020
PLD2310018
PLD2325002
PLD2328034
PLD2339021
PLD2310024
PLD2325003
PLD2328035
PLD2339022
PLD2310025
PLD2325004
PLD2328036
PLD2339023
PLD2310026
PLD2325005
PLD2328037
PLD2339024
PLD2310030
PLD2325006
PLD2328038
PLD2339025
PLD2311001
PLD2325007
PLD2328039
PLD2339026
PLD2311012
PLD2325009

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93700
Status: Active
Manufacturer: Baxter Healthcare Corporation
Sold By: Authorized Medical Distributors
Manufactured In: United States
Units Affected: 2 products (8 devices; 67 devices)
Distributed To: Alabama, Arizona, California, Florida, Georgia, Iowa, Kentucky, Maryland, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New Hampshire, New Jersey, Nevada, New York, Oregon, South Dakota, Texas, Washington, 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.