U.S. flag An official website of the United States government
  1. Home
  2. Medical Devices
  3. Medical Device Safety
  4. Medical Device Recalls
  5. DeRoyal Industries, Inc. Recalls Tracecarts Containing 16FR Urine Meter Foley Under Recall by Nurse Assist
  1. Medical Device Recalls

DeRoyal Industries, Inc. Recalls Tracecarts Containing 16FR Urine Meter Foley Under Recall by Nurse Assist

The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.

Recalled Product

  • Product Names: GeoMed Custom Tracecarts
  • Product Codes: LRO
  • Model Numbers:
    • 53-1829 Laminectomy Tracecart
    • 53-1831 Ortho Total Joint Tracecart
    • 53-1836 General Surgery Tracecart
  • Distribution Dates: August 25, 2022 to September 26, 2023
  • Devices Recalled in the U.S.: 134
  • Date Initiated by Firm: February 14, 2024

Device Use

The DeRoyal Tracecart is a general surgery tray that includes surgical drape and drape accessories used during surgical procedures to maintain a sterile field, provide a barrier against contamination, and aid in the organization of surgical instruments and supplies. The kits in this recall include the Laminectomy, Ortho Total Joint, and General Surgery Tracecarts.

The 16FR Urine Meter Foley mentioned in the kits is a urinary catheter with a meter for measuring urine output, commonly used in surgical and medical settings to manage urinary retention or monitor urinary output during procedures.

Reason for Recall

DeRoyal is recalling certain Surgical Tracecarts that contain a Nurse Assist 16FR Silver Urine Meter Foley. The Nurse Assist 16FR Urine Meter Foley is one of the items found within the firm's Tracecarts. This recall is in direct response to Nurse Assist LLC's, November 6, 2023, recall over sterility concerns. The rest of the items contained in the tracecart are not affected or impacted by this recall.

The use of the affected trays may cause serious adverse health consequences.

There have been no reported injuries and no reports of death.

Who May be Affected  

  • Health care providers using DeRoyal Tracecarts
  • People who receive care using DeRoyal Tracecarts

What to Do

On February 13, 2024, DeRoyal Industries, Inc. sent all affected customers an Urgent Recall Notice.

The letter requested customers to:

  • Utilize the included Affected Products Listing to identify affected surgical packs and place them in quarantine to prevent further use.
  • Return any Nurse Assist 16FR Urine Meter Foley units to DeRoyal for appropriate handling.
  • Complete the provided NOTICE OF RETURN FORM, indicating all affected products.
  • Inform all locations where these products have been distributed about the recall and advise them accordingly.

Contact Information

Customers in the U.S. with questions about this recall should contact DeRoyal Industries, Inc. at 865-362-4203.

Additional Resources

How do I report a problem?

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using an online form, regular mail, or FAX.


Subscribe to Medical Device Safety and Recalls

Sign up to receive email updates on medical device recalls, safety communications, and other safety information.

Back to Top