AVANOS* 122548Recalls & reported problems
Avanos Medical, Inc. · BALLARD* Oral Care Mini Swab with Reinforced Plastic Handle · Class 1
- 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 00609038472553), received between Aug 21, 2026 and Aug 21, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Fragmentation” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Material Fragmentation1
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.
MalfunctionAug 21, 2026Material Fragmentation
It was reported that Product was used on a patient, and the sponge dislodge in the patient's mouth.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50361542 ↗
Other APPLICATOR, ABSORBENT TIPPED, NON-STERILE devices
- AVANOS* 12251Avanos Medical, Inc. · APPLICATOR, ABSORBENT TIPPED, NON-STERILE1 report
- Q-Care 6962Sage Products, LLC · APPLICATOR, ABSORBENT TIPPED, NON-STERILE1 report
- Q-Care 6804Sage Products, LLC · APPLICATOR, ABSORBENT TIPPED, NON-STERILE1 report
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.