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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/Surgical Equipment

DeRoyal Industries Inc: Surgical Tracecarts Recalled Due to Compromised Sterile Urine Meters

Agency Publication Date: March 29, 2024
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Summary

DeRoyal Industries has recalled 134 GeoMed Custom Tracecarts—specifically the Ortho Total Joint and General Surgery models—because they contain a previously recalled Nurse Assist 16FR Silver Urine Meter Foley catheter. These surgical kits are used in clinical settings and the included urine meter component may not be sterile, which can lead to serious health complications for patients. Healthcare facilities in Florida are affected and should immediately identify and sequester any remaining kits from the specified lot numbers.

Risk

The inclusion of a non-sterile urine meter in these surgical carts poses a significant risk of infection or other serious health complications for patients undergoing surgery. While no specific injuries were mentioned in this report, the underlying component was recalled due to potential sterility issues.

What You Should Do

  1. Check your facility inventory for GeoMed Custom Tracecarts: Ortho Total Joint Tracecart (REF 53-1831) and General Surgery Tracecart (REF 53-1836).
  2. For Ortho Total Joint Tracecarts (GTIN 0749756598088), look for lot numbers 57587017, 57760377, 58185167, 58628933, 58834059, 58864266, 59223364, 59355050, or 59548003.
  3. For General Surgery Tracecarts (GTIN 0749756598132), look for lot numbers 58654875, 58736096, 59146688, 59223356, 59443367, 59510136, 59515455, or 59661866.
  4. Immediately stop using any affected tracecarts and sequester them to prevent further clinical use.
  5. Contact your healthcare provider or DeRoyal Industries Inc at their Powell, Tennessee location (200 Debusk Ln) for further instructions regarding the return or remediation of these products.
  6. Contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls for additional information regarding this safety recall.

Your Remedy Options

📋Other Action

Quarantine and contact manufacturer

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

Affected Products

Product: GeoMed Custom Tracecarts Ortho Total Joint Tracecart
Model / REF:
53-1831
UPC Codes:
0749756598088
Lot Numbers:
57587017 (Exp 2/1/2024)
57760377 (Exp 2/1/2024)
58185167 (Exp 5/1/2024)
58628933 (Exp 6/1/2024)
58834059 (Exp 9/1/2024)
58864266 (Exp 7/1/2024)
59223364 (Exp 7/1/2024)
59355050 (Exp 2/1/2025)
59548003 (Exp 5/1/2025)
Date Ranges: exp 2/1/2024, exp 5/1/2024, exp 6/1/2024, exp 9/1/2024, exp 7/1/2024, exp 2/1/2025, exp 5/1/2025
Product: GeoMed Custom Tracecarts General Surgery Tracecart
Model / REF:
53-1836
UPC Codes:
0749756598132
Lot Numbers:
58654875 (Exp 6/1/2024)
58736096 (Exp 6/1/2024)
59146688 (Exp 7/1/2024)
59223356 (Exp 7/1/2024)
59443367 (Exp 11/1/2024)
59510136 (Exp 11/1/2024)
59515455 (Exp 3/1/2025)
59661866 (Exp 5/1/2025)
Date Ranges: exp 6/1/2024, exp 7/1/2024, exp 11/1/2024, exp 3/1/2025, exp 5/1/2025

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94129
Status: Active
Manufacturer: DeRoyal Industries Inc
Sold By: Direct distribution to healthcare facilities
Manufactured In: United States
Units Affected: 134 tracecarts
Distributed To: Florida

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 · 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.