DeRoyal 71-C520Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00749756579070), received between Jan 8, 2025 and Jan 8, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Failure to Seal” (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. Jan 15, 2025Open, Classified

   The tubing may not ensure that the yankauer stays intact, and secure to the tubing / yankauer connection for a tight seal. This could result in inadequate suction and cause delay in patient care.

   Z-1174-2025 · Root cause: Device Design · 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.

• MalfunctionJan 8, 2025Failure to Seal; Failure to Seal

  A USER FACILITY REPORTED, "THE SUCTION HANDLE WILL ONLY WORK/SEAL PROPERLY ON ONE END OF THE SUCTION TUBING. THE YANKEUR DOES NOT STAY ON AND THERE IS NO TIGHT SEAL. IT HAS BECOME A SAFETY ISSUE BECAUSE THEY NEED RAPID ACCESS TO RELIABLE SUCTION WITHOUT MISHAPS IN CONNECTIONS."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21106360 ↗