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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/Diagnostic Equipment

Shimadzu SIL-40C Autosamplers Recalled for Technical Failure Risk

Agency Publication Date: November 26, 2024
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Summary

Shimadzu Corp. has recalled 48 units of its SIL-40C XR CL and SIL-40C X3 CL laboratory autosamplers because condensation can form and drip onto the device's main circuit board. This water can cause the electronics to fail, leading to errors in how the machine moves or communicates. While no injuries have been reported, this defect can lead to significant delays in processing patient samples and obtaining test results.

Risk

Water dripping onto the main board can cause communication errors or movement failures in the drive units. This malfunction can prevent the device from testing samples, potentially leading to delays in medical diagnosis or treatment for patients.

What You Should Do

  1. This recall affects Shimadzu Autosampler models SIL-40C XR CL and SIL-40C X3 CL with firmware versions below 1.16.
  2. Identify if your device is affected by checking the model and serial number located on the manufacturer's label; see the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled product.
  4. Contact Shimadzu Corp. or your authorized medical distributor to arrange for a return, replacement, or technical correction of the instrument.
  5. Call the FDA Consumer Complaint hotline at 1-888-463-6332 for additional information regarding this recall.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Autosampler, Model SIL-40C XR CL
Variants: Firmware versions below 1.16
Model / REF:
SIL-40C XR CL
Serial Numbers:
L2C316051002
L2C316051003
L2C316051004
L2C316051005
L2C316051006
L2C316051007
L2C316151012
L2C316151013
L2C316151014
L2C316151015
UDI:
04540217420582

Recall #: Z-0554-2025

Product: Autosampler, Model SIL-40C X3 CL
Variants: Firmware versions below 1.16
Model / REF:
SIL-40C X3 CL
Serial Numbers:
L2C305850001
L2C305950002
L2C306151025
L2C306051001
L2C306051002
L2C306051003
L2C306051004
L2C306051005
L2C306051007
L2C306051006
L2C306051008
L2C306051009
L2C306051010
L2C306051011
L2C306051012
L2C306051013
L2C306051014
L2C306051015
L2C306151017
L2C306151018
L2C306151022
L2C306151023
L2C306151024
L2C306151026
L2C306151028
L2C306151027
L2C306151029
L2C306151030
L2C306151031
L2C306151032
L2C306151033
L2C306151034
L2C306151035
L2C306151036
L2C306151037
L2C306151038
L2C306151040
L2C306151039
UDI:
04540217420575

Recall #: Z-0554-2025

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95633
Status: Active
Manufacturer: Shimadzu Corp. Analytical & Measuring Instruments Div.
Sold By: Authorized Medical Distributors
Manufactured In: Japan
Units Affected: 48
Distributed To: Delaware, Pennsylvania

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.