DeRoyal 53-1831Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00749756598088), received between Oct 3, 2024 and Oct 3, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Feb 13, 2024Open, Classified

   DeRoyal manufactured and distributed Surgical Tracecarts that contain a Nurse Assist 16FR Silver Urine Meter Foley which were subsequently recalled.

   Z-1382-2024 · Root cause: Other · FDA record ↗

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 3, 2024Break; Break

  A YANKAUER SUCTION BROKE DURING A SURGERY IN THE OPERATING ROOM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20358628 ↗