Toothette Oral Care 6512Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00618029800633), received between May 23, 2018 and Mar 19, 2026 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Material Separation” (10 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 19, 2026Material Separation

  REPORT RECEIVED OF A SUCTION SWAB DISENGAGEMENT. THE REPORTER STATED ON AN UNKNOWN DATE IN (B)(6) 2025, WHILE HE WAS USING A SUCTION SWAB TO PERFORM ORAL CARE FOR HIS SON, A SMALL PIECE OF FOAM DISENGAGED FROM THE SPONGE PORTION OF THE DEVICE AND ENTERED THE PATIENT¿S MOUTH. THE PATIENT WAS DESCRIBED AS A 33-YEAR-OLD MALE WITH A HISTORY OF TRAUMATIC BRAIN INJURY AND ANOXIC BRAIN INJURY. PER THE REPORTER, THE PATIENT WAS ALERT AND ORIENTED BUT NONVERBAL, WITH THE ABILITY TO RELIABLY FOLLOW COMMANDS. THE REPORTER FURTHER STATED THAT THE PATIENT WEIGHED APPROXIMATELY 220 POUNDS AND WAS 6 FEET 3 INCHES TALL. THE REPORTER STATED THE EVENT OCCURRED WITH INITIAL USE OF THE DEVICE. THE REPORTER STATED THAT THE PATIENT DID NOT BITE THE PRODUCT AND THAT NO BITE BLOCK WAS IN USE AT THE TIME OF THE EVENT. THE REPORTER FURTHER STATED THAT THE PATIENT HAD NO ORAL HARDWARE, WAS NOT INTUBATED, AND DID NOT HAVE CHIPPED TEETH THAT COULD HAVE CONTRIBUTED TO THE FOAM DISENGAGEMENT. THE REPORTER STATED THAT THE DISENGAGED PIECE OF FOAM WAS EASILY REMOVED FROM THE PATIENT¿S MOUTH USING SUCTION AND THEIR FINGERS. NO ADVERSE EFFECTS WERE REPORTED. LOT INFORMATION FOR THE AFFECTED DEVICE WAS PROVIDED. THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24641581 ↗
• MalfunctionMar 19, 2026Material Separation

  REPORT RECEIVED OF A SUCTION SWAB DISENGAGEMENT. THE REPORTER STATED ON AN UNKNOWN DATE IN (B)(6) 2025, WHILE HE WAS USING A SUCTION SWAB TO PERFORM ORAL CARE FOR HIS SON, A SMALL PIECE OF FOAM DISENGAGED FROM THE SPONGE PORTION OF THE DEVICE AND ENTERED THE PATIENT¿S MOUTH. THE PATIENT WAS DESCRIBED AS A 33-YEAR-OLD MALE WITH A HISTORY OF TRAUMATIC BRAIN INJURY AND ANOXIC BRAIN INJURY. PER THE REPORTER, THE PATIENT WAS ALERT AND ORIENTED BUT NONVERBAL, WITH THE ABILITY TO RELIABLY FOLLOW COMMANDS. THE REPORTER FURTHER STATED THAT THE PATIENT WEIGHED APPROXIMATELY 220 POUNDS AND WAS 6 FEET 3 INCHES TALL. THE REPORTER STATED THE EVENT OCCURRED WITH INITIAL USE OF THE DEVICE. THE REPORTER STATED THAT THE PATIENT DID NOT BITE THE PRODUCT AND THAT NO BITE BLOCK WAS IN USE AT THE TIME OF THE EVENT. THE REPORTER FURTHER STATED THAT THE PATIENT HAD NO ORAL HARDWARE, WAS NOT INTUBATED, AND DID NOT HAVE CHIPPED TEETH THAT COULD HAVE CONTRIBUTED TO THE FOAM DISENGAGEMENT. THE REPORTER STATED THAT THE DISENGAGED PIECE OF FOAM WAS EASILY REMOVED FROM THE PATIENT¿S MOUTH USING SUCTION AND THEIR FINGERS. NO ADVERSE EFFECTS WERE REPORTED. LOT INFORMATION FOR THE AFFECTED DEVICE WAS PROVIDED. THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24641577 ↗
• MalfunctionJun 5, 2025Material Separation; Material Separation

  NO ADDITIONAL EVENT INFORMATION HAS BEEN RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22150189 ↗
• MalfunctionJun 5, 2025Material Separation; Material Separation

  NO ADDITIONAL EVENT INFORMATION HAS BEEN RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22150025 ↗
• MalfunctionJun 5, 2025Material Separation; Material Separation

  NO ADDITIONAL EVENT INFORMATION HAS BEEN RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22149764 ↗
• MalfunctionJan 22, 2025Material Separation; Material Separation

  REPORT RECEIVED OF A SUCTION SWAB DISENGAGEMENT. REPORTER STATED HE WAS USING A SUCTION SWAB WHILE PERFORMING ORAL CARE WITHOUT A BITE BLOCK IN PLACE ON HIS SON. A PIECE OF THE SWAB BECAME DETACHED FROM THE DEVICE DURING INITIAL USE OF THE DEVICE. REPORTER STATED HIS SON HAS A TRACHEOSTOMY AND CANNOT FOLLOW COMMANDS DUE TO A TRAUMATIC BRAIN INJURY (TBI). REPORTER STATED HIS SON HAS NO ORAL HARDWARE AND DID NOT BITE THE DEVICE. REPORTER STATED HE DID NOT USE EXCESSIVE FORCE WHILE PERFORMING ORAL CARE. THE REPORTER STATED HE WAS ABLE TO RETRIEVE THE PIECE FROM HIS SON¿S MOUTH WITH HIS FINGERS. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE OUTCOMES. NO PHOTOS OF THE DEVICE ARE AVAILABLE, AND THE DEVICE HAS BEEN DISCARDED. LOT INFORMATION WAS PROVIDED. ALTHOUGH REQUESTED, NO SAMPLE PRODUCT WAS RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21213588 ↗
• MalfunctionDec 13, 2024Material Separation; Material Separation

  REPORT RECEIVED OF SUCTION SWAB BREAKING APART. NO OTHER DETAILS WERE PROVIDED. NO LOT INFORMATION OR PHOTOS WERE PROVIDED. NO INFORMATION REGARDING THE LOCATION OR AVAILABILITY OF THE DEVICE FOR RETURN WAS PROVIDED. ALTHOUGH ADDITIONAL INFORMATION WAS REQUESTED, NO ADDITIONAL INFORMATION WAS RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20926480 ↗
• MalfunctionJun 29, 2022Material Separation; Material Separation

  REPORT RECEIVED OF A SUCTION ORAL SWAB DISENGAGEMENT. REPORTER STATED A SUCTION ORAL SWAB DISENGAGED INSIDE THE PATIENT'S MOUTH. REPORTER DID NOT RESPOND TO FOUR ATTEMPTS MADE TO OBTAIN ADDITIONAL INFORMATION. INVOLVED DEVICE WAS NOT AVAILABLE FOR RETURN BUT LOT NUMBER WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14853809 ↗
• MalfunctionDec 14, 2020Material Separation; Material Separation

  REPORT RECEIVED OF A USER ERROR RESULTING IN A SUCTION ORAL SWAB DISENGAGEMENT. REPORTER, LAY PERSON, STATED SHE PERFORMED ORAL CARE ON HER (B)(6) YEAR OLD SON WHO SUFFERS FROM A TRAUMATIC BRAIN INJURY AND WAS UNABLE TO FOLLOW COMMANDS. REPORTER STATED HER SON BIT DOWN ON THE STICK OF THE SUCTION ORAL SWAB AND A PIECE OF THE STICK WITH ATTACHED FOAM BROKE OFF, AND BECAME DISENGAGED INSIDE HER SONS THROAT. REPORTER STATED SHE CALLED 911 BECAUSE HER SON WAS IN DISTRESS. REPORTER STATED IT TOOK HER HUSBAND APPROXIMATELY 2 MINUTES TO SUCCESSFULLY RETRIEVE THE PIECE OF SUCTION ORAL SWAB WITH ATTACHED FOAM . REPORTER STATED THE PARAMEDICS ARRIVED AT THAT TIME AND NO TREATMENT WAS NEEDED OR PROVIDED. THE REPORTED ISSUE OCCURRED DURING INITIAL USE OF THE DEVICE. INSTRUCTIONS FOR USE STATE, A BITE BLOCK SHOULD BE USED WHEN PERFORMING ORAL CARE ON PATIENTS WITH ALTERED LEVELS OF CONSCIOUSNESS OR THOSE WHO CANNOT COMPREHEND COMMANDS. REPORTER STATED THAT ALTHOUGH THE PATIENT WAS UNABLE TO FOLLOW COMMANDS, A BITE BLOCK WAS NOT USED AT THE TIME OF THE INCIDENT. THE DEVICE WAS DISCARDED, HOWEVER, LOT INFORMATION WAS PROVIDED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Distress

  MAUDE report 11004321 ↗
• MalfunctionMay 23, 2018Material Separation; Material Separation

  REPORT RECEIVED OF A MALFUNCTION RESULTING IN SUCTION SWAB FOAM DISENGAGEMENT. ON (B)(6) 2018, A DISTRIBUTOR RECEIVED A REPORT THAT FOAM FELL OFF THE TOP OF THE SUCTION ORAL SWAB. THE DISTRIBUTOR'S REPORT STATES NO INJURY OCCURRED. MULTIPLE ATTEMPTS TO OBTAIN FURTHER INFORMATION WERE UNSUCCESSFUL. THE DISTRIBUTOR REPORTED THAT THE INVOLVED PRODUCT WAS DISCARDED; HOWEVER, SAME LOT SAMPLES WERE RETURNED FOR EVALUATION. ALTHOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7536555 ↗