Ballard* 24-Hour Oral Care Kit 97021Recalls & reported problems
Avanos Medical, Inc. · BALLARD* ORAL CARE q4 KIT · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00609038970219), received between Mar 5, 2025 and Aug 8, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Excess Flow or Over-Infusion” (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
- Excess Flow or Over-Infusion1
- Material Integrity Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 8, 2025Excess Flow or Over-Infusion; Excess Flow or Over-Infusion
THE NURSE REPORTED THE SUCTION WAS STILL ON WHILE THE SWITCH ON THE HANDLE WAS TURNED OFF; DISCOVERED DURING PATIENT USE. THERE WAS NO REPORTED INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22758270 ↗MalfunctionMar 5, 2025Material Integrity Problem; Material Integrity Problem
WHILE THE CRITICAL CARE NURSE WAS PERFORMING ORAL CARE ON THE PATIENT THE SUCTION SWAB FELL APART IN THE PATIENT'S MOUTH AND THE NURSE HAD TO PHYSICALLY REMOVE THE SPONGE AND GREEN TIP FROM THE PATIENT'S MOUTH. THERE WAS NO PATIENT INJURY; THE ORAL CARE DEVICE WAS REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21531683 ↗
Other Patient personal hygiene kit devices
- Q-Care 6464Sage Products, LLC · Patient personal hygiene kit3 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
- 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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