Ballard* 24-Hour Oral Care Kit 13904Recalls & reported problems
Avanos Medical, Inc. · BALLARD* ORAL CARE q2 KIT with CHG · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00609038139043), received between Mar 12, 2025 and Mar 12, 2025 — classified as 1 malfunction.
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.
Reports received per month
Most reported problems
Device problems
- Appropriate Device Problem Term/Code Not Available1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 12, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED, WHEN USING THE 24 HOUR ORAL CARE KIT, THE SPONGE APPEARED NOT TO HAVE GLUE ON IT AND IT CAME OFF IN THE INTUBATED PATIENT'S MOUTH; FORCEPS WERE USED TO REMOVE THE SPONGE FROM THE PATIENT'S MOUTH. THERE WAS NO REPORTED INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21584943 ↗
Other Patient personal hygiene kit devices
- Q-Care 6464Sage Products, LLC · Patient personal hygiene kit3 reports
- Ballard* 24-Hour Oral Care Kit 97021Avanos Medical, Inc. · Patient personal hygiene kit2 reports
- Q-Care 6994Sage Products, LLC · Patient personal hygiene kit1 report
- Sage Self Oral Care 6304Sage Products, LLC · Patient personal hygiene kit1 report
- Toothette Oral Care 6513Sage Products, LLC · Patient personal hygiene kit1 report
- Ballard* mini 24-Hour Oral Care Kit 45255Avanos Medical, Inc. · Patient personal hygiene kit1 report
- Toothette Oral Care 6550Sage Products, LLC · Patient personal hygiene kit1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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