Q-Care 6964Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00618029830753), received between Aug 12, 2021 and Jul 10, 2026 — classified as 6 malfunctions.

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 10, 2026Material Separation

  A 06/18/2026 SEARCH OF THE FDA MANUFACTURER AND USER FACILITY DEVICE EXPERIENCE (MAUDE) IDENTIFIED A REPORT (MW5159828) OF YANKAUER SOFT TIP DISENGAGEMENT. DURING ORAL CARE, THE PATIENT BIT DOWN ON THE DEVICE, RESULTING IN THE SOFT TIP DISENGAGING FROM THE YANKAUER. THE DETACHED SOFT TIP WAS SUBSEQUENTLY REMOVED FROM THE PATIENT'S MOUTH. ADDITIONAL INFORMATION WAS REQUESTED; HOWEVER, NO FURTHER DETAILS WERE PROVIDED. THE DEVICE WAS NOT AVAILABLE FOR EVALUATION AS IT WAS DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25787247 ↗
• MalfunctionMar 10, 2025Material Separation; Material Separation

  REPORT RECEIVED OF A SWAB DISENGAGEMENT RELATED TO USER ERROR. REPORTER STATED A 40-YEAR-OLD MALE, ALERT AND ORIENTED PATIENT WHO WAS ABLE TO FOLLOW COMMANDS, BIT DOWN ON A SUCTION SWAB STICK AT THE POINT WHERE THE STICK AND SPONGE MEET DURING ROUTINE ORAL CARE, CAUSING THE STICK TO BREAK AT THAT LOCATION. A BITE BLOCK WAS NOT IN USE AND THIS EVENT OCCURRED WITH INITIAL USE OF THE DEVICE. THE MANNER IN WHICH THE DEVICE WAS REMOVED FROM THE PATIENT'S MOUTH IS UNKNOWN. HOWEVER, THE REPORTER STATED NO MEDICAL INTERVENTION WAS REQUIRED, AND THE PATIENT DID NOT EXPERIENCE ANY ADVERSE CONSEQUENCES. THE EVENT DID NOT LEAD TO ANY DELAYS IN MEDICAL OR SURGICAL PROCEDURES. THE REPORTER PROVIDED THE AFFECTED LOT NUMBER AND A PHOTO OF THE DEVICE. ALTHOUGH REQUESTED, THE AFFECTED DEVICE WAS NOT RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21567698 ↗
• MalfunctionSep 13, 2024Material Separation; Material Separation

  REPORT RECEIVED OF A COVERED YANKAUER SOFT MOLDED TIP DISENGAGEMENT. THE REPORTER DID NOT HAVE FIRSTHAND KNOWLEDGE OF THE EVENT; HOWEVER, THEY PROVIDED THE FOLLOWING DETAILS. REPORTEDLY, A 77-YEAR-OLD FEMALE PATIENT WAS ADMITTED ON (B)(6) 2024 FOR ALTERED MENTAL STATUS AND RESPIRATORY DISTRESS. THE PATIENT WAS INITIALLY INTUBATED AT ADMISSION. THE PATIENT WAS EXTUBATED ON (B)(6) 2024; HOWEVER, THE CLINICAL DECISION WAS MADE TO REINTUBATE ON (B)(6) 2024. PRIOR TO INTUBATION, THE PATIENT WAS SUCTIONED WITH THE COVERED YANKAUER. THE PATIENT WAS AGITATED, AND A BITE BLOCK WAS NOT IN USE. THE PATIENT REPORTEDLY, WOULD FREQUENTLY BITE DOWN ON PRODUCTS INSERTED INTO THE ORAL CAVITY; HOWEVER, BITING COULD NOT BE CONFIRMED BY THE REPORTER AT THE TIME OF THE DISENGAGEMENT. THE YANKAUER TIP DISENGAGEMENT WAS NOT INITIALLY NOTED; HOWEVER, SHORTLY AFTER THE PATIENT WAS SUCTIONED, A PROVIDER OPENED THE ORAL CAVITY TO INTUBATE AND OBSERVED THE SOFT MOLDED TIP FROM THE YANKAUER IN THE PATIENT'S THROAT. THE PROVIDER WAS ABLE TO REMOVE THE YANKAUER TIP WITH THEIR FINGERS. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE CONSEQUENCES. ALTHOUGH THE AFFECTED DEVICE WAS DISCARDED, LOT INFORMATION AND PHOTOS O

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20216783 ↗
• MalfunctionMay 17, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  REPORT RECEIVED OF A SUCTION ORAL SWAB DISENGAGEMENT. REPORTER STATED ON (B)(6) 2023, A SUCTION ORAL SWAB DEVICE WAS IN USE ON A 70-YEAR-OLD FEMALE PATIENT WHO WAS AWAKE BUT COGNITIVELY IMPAIRED, HAD NO TEETH AND HAD A TRACHEOSTOMY, WHEN THE ENTIRE FOAM SPONGE FROM THE SUCTION SWAB DISENGAGED FROM THE STICK. REPORTER STATED THAT A BITE BLOCK WAS NOT IN USE AT THE TIME OF THE INCIDENT AND THE PATIENT DID NOT BITE DOWN ON THE DEVICE. THE TECHNICIAN WAS ABLE TO REMOVE THE DISENGAGED FOAM FROM THE PATIENT¿S MOUTH WITH HER FINGERS. THERE WAS NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT RELATED TO THIS EVENT. THE DEVICE RELATED TO THIS REPORT WAS DISCARDED BY THE USER. THE REPORTER STATED THAT THE LOT NUMBER OF THE DEVICE USED DURING THIS REPORTED EVENT WAS UNKNOWN . THE CUSTOMER RETURNED PRODUCT FROM TWO DIFFERENT LOT NUMBERS IN STOCK AT THE TIME OF THE EVENT FOR EVALUATION. ALTHOUGH REQUESTED, NO OTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16948066 ↗
• MalfunctionMay 17, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  REPORT RECEIVED OF A SUCTION ORAL SWAB DISENGAGEMENT. REPORTER STATED ON 04/18/2023, A SUCTION ORAL SWAB DEVICE WAS IN USE ON A 70-YEAR-OLD FEMALE PATIENT WHO WAS AWAKE BUT COGNITIVELY IMPAIRED, HAD NO TEETH AND HAD A TRACHEOSTOMY, WHEN THE ENTIRE FOAM SPONGE FROM THE SUCTION SWAB DISENGAGED FROM THE STICK. THE REPORTER STATED THAT A BITE BLOCK WAS NOT IN USE AT THE TIME OF THE INCIDENT AND THE PATIENT DID NOT BITE DOWN ON THE DEVICE. THE TECHNICIAN WAS ABLE TO REMOVE THE DISENGAGED FOAM FROM THE PATIENT¿S MOUTH WITH HER FINGERS. THERE WAS NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT RELATED TO THIS EVENT. THE DEVICE RELATED TO THIS REPORT WAS DISCARDED BY THE USER. THE REPORTER STATED THAT THE LOT NUMBER OF THE DEVICE USED DURING THIS REPORTED EVENT WAS UNKNOWN. THE CUSTOMER RETURNED PRODUCT FROM TWO DIFFERENT LOTS IN STOCK AT THE TIME OF THE EVENT FOR EVALUATION. ALTHOUGH REQUESTED, NO OTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16947380 ↗
• MalfunctionAug 12, 2021Material Separation; Material Separation

  REPORT RECEIVED OF A SUCTION ORAL TOOTHBRUSH FOAM DISENGAGEMENT. THE REPORTER STATED THE GREEN FOAM ON THE BACK OF THE SUCTION ORAL TOOTHBRUSH DISENGAGED AND WAS SWALLOWED BY THE PATIENT. REPORTER STATED THIS WAS THE THIRD TIME THE GREEN FOAM HAS COME OFF THE BACK OF THE SUCTION ORAL TOOTHBRUSH AND A PATIENT HAS SWALLOWED IT. A PHOTOGRAPH WAS PROVIDED AND PRODUCT WAS RETURNED FOR EVALUATION. ALTHOUGH SEVERAL ATTEMPTS WERE MADE TO THE REPORTER TO OBTAIN ADDITIONAL INFORMATION, NO RESPONSE WAS RECEIVED.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12315976 ↗