Q-Care 6629Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00618029800930), received between Sep 12, 2025 and Sep 12, 2025 — classified as 1 malfunction.

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

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.

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.

• MalfunctionSep 12, 2025Material Separation; Material Separation

  REPORT RECEIVED OF A COVERED YANKAUER SOFT OVERMOLDED TIP DISENGAGEMENT. REPORTER STATED A FAMILY MEMBER WAS PERFORMING ORAL CARE ON AN 86-YEAR-OLD MALE ALERT AND ORIENTED BUT NONVERBAL PATIENT WITH A TRACHEOSTOMY IN PLACE, WHEN THE SOFT OVERMOLDED TIP OF THE DEVICE DISENGAGED INTO THE PATIENT¿S MOUTH. REPORTER STATED THE EVENT TOOK PLACE ON INITIAL USE OF THE DEVICE. THE PATIENT WAS NOT INTUBATED, AND A BITE BLOCK WAS NOT IN USE AT THE TIME OF THE EVENT. HOWEVER, PER THE REPORTER, THE PATIENT HAS END STAGE PARKINSON'S DISEASE AND HAS NO TEETH, SO HE WOULD NOT HAVE HAD THE STRENGTH OR ABILITY TO BITE DOWN ON THE DEVICE. THE FAMILY MEMBER PERFORMING ORAL CARE WAS ABLE TO REMOVE THE DISENGAGED SOFT OVERMOLDED TIP OF THE YANKAUER FROM THE PATIENT'S MOUTH WITH THEIR FINGERS AND THE PATIENT DID NOT EXPERIENCE ANY ADVERSE CONSEQUENCES RELATED TO THE EVENT. LOT INFORMATION AND A PHOTO WERE PROVIDED. THE AFFECTED DEVICE WAS DISCARDED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23044414 ↗