Applicator, Absorbent Tipped, Non-Sterile
FDA adverse event reports and recall history for applicator, absorbent tipped, non-sterile (product code KXF), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 549
- Deaths
- 6
- Injuries
- 189
- Malfunctions
- 301
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2023-04-19TerminatedUnder Investigation by firm
Avanos Ballard Oral Care Swab, Bulk Packed, Product Codes: a) 12241, b) 12243, c) 12251
Incorrect expiration date.
- 2013-05-01TerminatedProcess change control
MediChoice Rayon Tipped OB/GYN Applicator, 8 inch, Plastic Shaft, Non-Sterile, Item Numbers WOD5001 and WOD5002. Product Usage: Usage: An absorbent tipped applicator is a device intended for medical purposes that consists of an absorbent swab on a wooden, paper, or plastic stick. The device is used to apply medications to, or to take specimens from, a patient.
Owens & Minor Distribution, Inc. is conducting a market withdrawal of MediChoice Applicator OB-GYN 8 inch product that does not meet our quality standards because the rayon may loosen or unravel from the applicator during use.
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