AVANOS* 12251Recalls & reported problems
Avanos Medical, Inc. · BALLARD* Oral Care Swabs, Bulk Packed · 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 00609038968780), received between Jun 25, 2026 and Jun 25, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Integrity Problem” (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 Integrity Problem1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 25, 2026Material Integrity Problem
IT WAS REPORTED THAT DURING ORAL CARE FOR THE RESIDENT, THE FOAM TIP OF THE SWAB DETACHED, "[AND FELL INTO THEIR MOUTH]". IT WAS ADDITIONALLY REPORTED, THAT THE RESIDENT WAS AT THE END OF LIFE AND REPORTEDLY WAS EXHIBITING MOUTH MOVEMENTS. THE FOAM WAS RETRIEVED WITH DIFFICULTY USING FINGERS. THERE WAS NO REPORT OF A DELAY IN THERAPY, HARM OR INJURY AS A RESULT OF THIS REPORTED EVENT.
Patient problems: Insufficient Information
MAUDE report 25627627 ↗
Other APPLICATOR, ABSORBENT TIPPED, NON-STERILE devices
- AVANOS* 122548Avanos 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.