Q-CareRecalls & reported problems across all models

We found 9 models of Q-Care by Sage Products, LLC in the FDA's device registry (GUDID). Together they are named in 20 adverse event reports in the FDA's MAUDE database, received between Mar 21, 2019 and Aug 7, 2026 — classified as 4 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Material Separation” (18 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Q-Care problems

Q-Care models

9 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Q-Care 6964

  CATHETER AND TIP, SUCTION
  6 reports
• Q-Care 6429

  CATHETER AND TIP, SUCTION
  4 reports
• Q-Care 6464

  Patient personal hygiene kit
  3 reports
• Q-Care 6639

  CATHETER AND TIP, SUCTION
  2 reports
• Q-Care 6629

  CATHETER AND TIP, SUCTION
  1 report
• Q-Care 6904

  CATHETER AND TIP, SUCTION
  1 report
• Q-Care 6962

  APPLICATOR, ABSORBENT TIPPED, NON-STERILE
  1 report
• Q-Care 6994

  Patient personal hygiene kit
  1 report
• Q-Care 6804

  APPLICATOR, ABSORBENT TIPPED, NON-STERILE
  1 report

Recent Q-Care adverse event reports

The 15 most recent reports across all models, 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 ↗
• MalfunctionJul 16, 2026Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25845775 ↗
• 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 ↗
• MalfunctionJul 10, 2026Material Separation; Improper or Incorrect Procedure or Method

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25786034 ↗
• InjuryApr 3, 2026Material Separation

  REPORT RECEIVED OF A COVERED YANKAUER SOFT OVERMOLDED TIP DISENGAGEMENT DUE TO BITING. REPORTEDLY, A 42-YEAR-OLD MALE PATIENT WITH A HISTORY OF CEREBRAL PALSY WAS ADMITTED TO THE MEDICAL-SURG UNIT AT THE FACILITY ON AN UNKNOWN DATE WITH AN ADMITTING DIAGNOSIS OF (RESPIRATORY SYNCYTIAL VIRUS) RSV. ON (B)(6) 2026, A FAMILY MEMBER AT BEDSIDE USED THE COVERED YANKAUER TO ATTEMPT TO SUCTION THE PATIENT'S MOUTH. A BITE BLOCK WAS NOT IN USE. THE PATIENT BIT DOWN ON THE YANKAUER TUBE, BEHIND THE TIP. THE PATIENT'S FAMILY MEMBER ATTEMPTED TO PULL THE YANKAUER OUT OF THE PATIENT'S MOUTH. EVENTUALLY, THE PATIENT DID OPEN THEIR MOUTH AND THE YANKAUER WAS REMOVED. THE PATIENT THEN BEGAN TO EXPERIENCE, INCREASED HEART RATE, BLOOD PRESSURE AND COUGHING. STAFF THEN NOTICED THAT THE TIP WAS NO LONGER ATTACHED TO THE YANKAUER AND DETERMINED THAT THE PATIENT HAD ASPIRATED THE TIP. THE PATIENT WAS TRANSFERRED TO THE ICU, SEDATED AND ADMINISTERED A PARALYTIC. HE WAS INTUBATED AND A BRONCHOSCOPY WAS PERFORMED. THE DISENGAGED TIP OF THE DEVICE WAS LOCATED IN THE PATIENT'S RIGHT MAINSTEM BRONCHUS AND REMOVED. THE PATIENT RECOVERED FROM SEDATION AND WAS EXTUBATED WITHOUT ISSUE. THE PATIENT DID NOT EXPERIEN

  Patient problems: Airway Obstruction

  MAUDE report 24778654 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionJan 23, 2025Material Separation; Material Separation

  REPORT RECEIVED OF A SUCTION SWAB DISENGAGEMENT. IT WAS REPORTED THAT ¿WHILE DOING ORAL CARE THE SPONGE CAME OFF THE SWAB. IT BECAME LODGE IN THE PATIENT'S THROAT.¿ LOT INFORMATION WAS PROVIDED. THE AFFECTED SUCTION SWAB WAS RETURNED FOR EVALUATION. ALTHOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS RECEIVED, INCLUDING INFORMATION ABOUT ADVERSE CONSEQUENCES OR WHETHER ANY MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21218129 ↗
• 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 ↗
• 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 ↗
• MalfunctionMar 19, 2024Material Separation; Detachment of Device or Device Component; Material Separation; Detachment of Device or Device Component

  NO ADDITIONAL EVENT INFORMATION HAS BEEN RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18936398 ↗
• 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 ↗