Ballard* mini 24-Hour Oral Care Kit 45255Recalls & reported problems
Avanos Medical, Inc. · BALLARD* MINI ORAL CARE KIT · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00609038452555), received between Jul 7, 2025 and Jul 7, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Free or Unrestricted Flow” (1 report).
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
- Free or Unrestricted Flow1
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.
InjuryJul 7, 2025Free or Unrestricted Flow; Free or Unrestricted Flow
IT WAS REPORTED: WHILE OPERATING THE SUCTION HANDLE, THE BEDSIDE NURSE OBSERVED THE SUCTION REMAINED "ON" WHEN THE SWITCH WAS IN THE "OFF" POSITION. THERE WAS NO REPORTED INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22420272 ↗
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* 24-Hour Oral Care Kit 13904Avanos 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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