DeRoyal 71-C512Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00749756579063), received between Jan 15, 2025 and Feb 6, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Failure to Seal” (2 reports).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 6, 2025Failure to Seal; Failure to Seal

  A USER FACILITY REPORTED THAT THE 5MM TUBING WAS OBSERVED HAVING DIFFICULT WITH SECUREMENT OF ITEMS WITHIN THE "GRIP" OF THE CONNECTOR PERSISTED ON ALL OF THE TUBING SKUS IN THEIR INVENTORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21327164 ↗
• MalfunctionJan 15, 2025Failure to Seal; Failure to Seal

  A USER FACILITY REPORTED, "WE ARE HEARING CONCERNS FROM OUR GI ENDOSCOPY TEAM THAT THE NEWLY CONVERTED DEROYAL TUBING 71C512 IS NOT SEALING AS WELL AS THE CARDINAL TUBING. SPECIFICALLY, TUBING DISLODGING FROM OUR FLEXIBLE ENDO SCOPES DURING COLONOSCOPY AND UPPER GI PROCEDURES."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21160087 ↗