Medline MDS202105Recalls & reported problems
Medline Industries, Inc. · APPLICATOR,COTTON-TIP,WOOD,3,STRL · 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 20080196306463), received between Sep 30, 2026 and Sep 30, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (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
- Break1
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.
MalfunctionSep 30, 2026Break
This VMSR report summarizes 3 malfunction events that occurred between July 1 and September 30, 2025. The account reported that wooden applicator sticks (MDS202105) were splintering within the package prior to use. No patient information was available. No patient or user injuries were reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50945909 ↗
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- Specimen Collection Swab SW0102Typenex Medical LLC · Applicator, Absorbent Tipped, Sterile2 reports
- Cultura™ 00884450495834Merit Medical Systems, Inc. · APPLICATOR, ABSORBENT TIPPED, STERILE2 reports
- DeRoyal 31-249Deroyal Industries, Inc. · APPLICATOR, ABSORBENT TIPPED, STERILE1 report
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.