Z-1382-2024Class I

GeoMed Custom Tracecarts, REF Numbers: a) 53-1831 ORTHO TOTAL JOINT TRACECART, b) 53-1836 GENERAL SURGERY...

Name: Z-1382-2024 GeoMed Custom Tracecarts, REF Numbers: a) 53-1831 ORTHO TOTAL JOINT TRACECART, b) 53-1836 GENERAL SURGERY...
Creator: DeRoyal Industries Inc
Published: 2024-02-13
License: https://open.fda.gov/license/

DeRoyal Industries, Inc. / initiated 2024-02-13 / Open, Classified / root cause: manufacturing process

FDA source

DeRoyal Industries Inc began a recall of GeoMed Custom Tracecarts, REF Numbers: a) 53-1831 ORTHO TOTAL JOINT TRACECART, b) 53-1836 GENERAL SURGERY TRACECART on 2024-02-13. FDA classified it as Class I and gives the reason as "DeRoyal manufactured and distributed Surgical Tracecarts that contain a Nurse Assist 16FR Silver Urine Meter Foley which were subsequently recalled". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1382-2024
Classification: Class I
Status: Open, Classified
Initiated: 2024-02-13
Posted: 2024-03-29
Recalling firm: DeRoyal Industries, Inc.
Product: GeoMed Custom Tracecarts, REF Numbers: a) 53-1831 ORTHO TOTAL JOINT TRACECART, b) 53-1836 GENERAL SURGERY TRACECART
Product code: LRO General Surgery Tray
Reason for recall: DeRoyal manufactured and distributed Surgical Tracecarts that contain a Nurse Assist 16FR Silver Urine Meter Foley which were subsequently recalled.
Root cause tag: manufacturing process
FDA root cause: Other
Action: DeRoyal Industries notified their sole consignee via email on 02/13/2024. The notice explained the reason for recall, risk, and requested that the affected product Nurse Assist 16F Urine Meter Foley, be removed from the tracecarts and returned. The consignee was instructed to complete the NOTICE OF RETURN FORM, indicating all affected products found in your inventory and return the completed form to DeRoyal via fax to 865- 362-3716 or [email protected]. For questions regarding credit for the recall, email at [email protected] or call 865-362-4203.
Quantity in commerce: 134 tracecarts
Distribution: Florida
Product codes and lots: a) 53-1831 ORTHO TOTAL JOINT TRACECART, GTIN 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; b) 53-1836 GENERAL SURGERY TRACECART, GTIN 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1382-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1382-2024	Class I	Ongoing	Voluntary: Firm initiated	2024-04-03	2024-03-28

Product code LRO

K842648Class IIGeneral Surgery TrayDeroyal Industries, Inc. / cleared 1984-09-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)