Q-Care 6429Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00618029841353), received between Mar 21, 2019 and Aug 7, 2026 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Separation” (4 reports).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryAug 7, 2026Material Separation; Improper or Incorrect Procedure or Method

  It was reported that on (b)(6) 2026, during oral care suctioning, a healthcare provider utilized a Yankauer device and the patient bit down on the device. A bite block was not utilized. It is unknown whether the patient had a history of biting during oral care. As a result, the soft tip completely detached within the patient's mouth and was subsequently ingested. Following ingestion of the detached tip, the patient became tachypneic. Due to the reported ingestion, the patient required sedation and underwent an endoscopic procedure to locate and retrieve the detached soft tip. The tip was identified resting on top of the tracheostomy cuff and was successfully retrieved. No complications were reported during the procedure. Following retrieval, the disengaged soft tip was inspected and confirmed to have been recovered in its entirety. It was reported that the event did not prolong the patient's hospitalization. No additional information regarding the patient's clinical status was available. Although additional information was requested, no further information was received.

  Patient problems: Increased Respiratory Rate

  MAUDE report 50182707 ↗
• MalfunctionMar 26, 2025Material Separation; Material Separation

  THE REPORTER PROVIDED LOT INFORMATION FOR THE AFFECTED DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21702172 ↗
• InjuryAug 30, 2024Material Separation; Material Separation

  REPORT RECEIVED OF A COVERED YANKAUER SOFT MOLDED TIP DISENGAGEMENT. THE DEVICE WAS BEING USED ON A FEMALE PATIENT WITH AMYOTROPHIC LATERAL SCLEROSIS. REPORTER STATED THE AIDE NOTED THE PATIENT¿S COLOR HAD CHANGED ABOUT 20 MINUTES AFTER THE PATIENT WAS SUCTIONED. THE AIDE WENT TO SUCTION THE PATIENT AGAIN, AND NOTED THE TIP OF THE YANKAUER WAS GONE. THE AIDE NOTED THAT THE SOFT MOLDED TIP OF THE YANKAUER WAS IN THE PATIENT¿S THROAT. EMERGENCY MEDICAL SERVICE WAS CONTACTED AND WORKED ON THE PATIENT TO REMOVE THE DISENGAGED TIP. THE REPORTER STATED THEY HAD THE TWO PIECES OF THE DEVICE IN THEIR POSSESSION. HOWEVER, DESPITE SEVERAL ATTEMPTS TO CONTACT THE REPORTER FOR FOLLOW UP INFORMATION AND DEVICE RETURN, NO RESPONSE WAS RECEIVED.

  Patient problems: Airway Obstruction

  MAUDE report 20107196 ↗
• InjuryMar 21, 2019Material Separation; Material Separation

  REPORT RECEIVED OF A YANKAUER SUCTION TIP DISENGAGEMENT. REPORTER IS A LAY PERSON. REPORTER STATED ON (B)(6) 2019, HE EXECUTED SELF-SUCTIONING OF HIS TRACHEAL STOMA WHILE AT HOME. REPORTER STATED ON INITIAL USE OF DEVICE, HE USED THE YANKAUER, ¿TO CLEAN MY STOMA.¿ REPORTER STATED THE SOFT TIP OVER-MOLD OF THE YANKAUER DISENGAGED INSIDE HIS TRACHEAL STOMA AND HE WAS UNABLE TO REMOVE THE DISENGAGED TIP. REPORTER STATED HE WAS NOT IN RESPIRATORY DISTRESS AND WENT TO THE EMERGENCY DEPARTMENT AT 0930 HOURS. REPORTER STATED THAT AT 1500 HOURS THE DISENGAGED TIP WAS SUCCESSFULLY REMOVED BY THE EMERGENCY ROOM PHYSICIAN USING, ¿AN OSCILLOSCOPE WITH CLIP ATTACHMENT.¿ REPORTER STATED HE EXPERIENCED SORENESS AND COUGHING FOLLOWING THE INTERVENTION. REPORTER ADVISED HE HAS NEVER USED THE PRODUCT IN HIS ORAL CAVITY. REPORTER WAS ADVISED THE PRODUCT, AS SPECIFIED ON THE LABELING, IS NONSTERILE AND THE INTENDED USE IS FOR ORAL CAVITY SUCTIONING. REPORTER PROVIDED A PICTURE OF THE INVOLVED DEVICE, HOWEVER, REFUSED TO RETURN THE INVOLVED DEVICE FOR EVALUATION. REPORTER RETURNED THREE SAME LOT SAMPLE DEVICES FOR EVALUATION. ALTHOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS AVAILABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 8440304 ↗