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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

CardioQuip, LLC: Modular Cooler-Heater Recalled Due to Heating Chamber Malfunction and Fire Risk

Agency Publication Date: December 1, 2023
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Summary

CardioQuip, LLC is recalling 275 units of its Modular Cooler-Heater (Models MCH-1000(m) and MCH-1000(i)) because the heating chamber can malfunction, causing internal components to melt or burn. These devices are used in medical settings to regulate patient temperature, and a failure could lead to smoke or fire within the clinical environment. Affected units were distributed in 15 states and can be identified by specific serial numbers listed on the device's identification plate.

Risk

The heating chamber components may fail and overheat, resulting in the melting or burning of plastic and electrical parts. This poses a significant risk of fire, smoke inhalation, or device failure during a medical procedure.

What You Should Do

  1. Identify your device by checking the model and serial number on the identification plate. Affected Model MCH-1000(m) units include serial numbers such as 11160203, 11160204, 11160315, 11160316, 11160317, 11160318, 11160319, and 11160320 among others listed in the recall notice.
  2. Check for affected Model MCH-1000(i) serial numbers, which include 10160461, 10160463, 10160465, 10160466, 101060467, 10160468, 10161406, 10161408, 10161553, and 10161689 among others.
  3. If your device is affected, immediately contact your healthcare provider or CardioQuip, LLC for further instructions regarding the repair or inspection of the heating chamber.
  4. Contact CardioQuip, LLC directly at their headquarters in College Station, Texas, by calling 979-691-0202 or visiting their website for technical support and potential remedy options.
  5. For additional information or to report a problem, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Manufacturer initiated contact via letter

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

Affected Products

Product: CardioQuip Modular Cooler-Heater, Model: MCH-1000(m)
Model / REF:
MCH-1000(m)
Lot Numbers (150):
11160203
11160204
11160315
11160316
11160317
11160318
11160319
11160320
11161109
11161832
11161836
11161837
11161838
11161839
11160216
11160217
11160218
11160548
11160549
11160550
11160103
11160338
11160339
11160364
11160365
11160366
11161117
11161118
11161827
11161828
11161829
11161942
11161943
11161944
11161978
11162016
11162018
11160461
11160462
11160463
11160464
11160465
11160579
11161487
11161488
11161489
11161613
11161692
11161695
11161701
Product: CardioQuip Modular Cooler-Heater, Model: MCH-1000(i)
Model / REF:
MCH-1000(i)
Lot Numbers (124):
10160461
10160463
10160465
10160466
101060467
10160468
10161406
10161408
10161553
10161689
10160275
1016276
1016277
10160274
10161065
10161066
10160825
10160826
10160827
10160828
10161140
10161141
10160830
10160831
10160832
10160833
10161543
10160449
10160450
10160451
10160452
1016050512
10160513
10160781
10160785
10160786
10160787
10160788
10160789
10160790
10160791
10160792
10160793
10160794
10160795
10161130
10161131
10161329
10161517
10160758

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93347
Status: Active
Manufacturer: CardioQuip, LLC
Sold By: Hospitals and medical facilities; Direct distribution
Manufactured In: United States
Units Affected: 2 products (150 units; 125 units)
Distributed To: Texas, Indiana, Illinois, Wisconsin, Florida, New Jersey, Pennsylvania, Kentucky, Virginia, West Virginia, Connecticut, California, Washington, Alabama, Iowa

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.