AVANOS 13539Recalls & reported problems
Avanos Medical, Inc. · ON-Q* Expansion Kits with SILVERSOAKER* Catheter 10 in (25 cm), Needle 8 in. x 17 GA · Class 2
Data updated Oct 16, 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 00193494135393), received between Aug 25, 2025 and May 12, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (2 reports).
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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Break2
Patient problems
- Eye Pain2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 12, 2026Break
IT WAS REPORTED VIA FDA MEDWATCH / FDA USER FACILITY REPORT MW REPORT 22885309 THE FOLLOWING: RN OPENED AVANOS ON-Q ANTIMICROBIAL EXPANSION KIT TO STERILE BACK TABLE. RN HOLDING KIT OPEN FOR SCRUB TECH TO GRAB SUPPLIES. ANOTHER RN REPORTED HEARING "POP" SOUND AND THE SHEATHED INTRODUCER IN PACKAGE SLING-SHOTTED OUT OF PACKAGE INTO THE FIRST RN'S EYE. RN USED EYEWASH STATION AND EXAMINED EYE. MILD PAIN PRESENT BUT NO OTHER INJURIES NOTED.
Patient problems: Eye Pain
MAUDE report 25156662 ↗MalfunctionAug 25, 2025Break
RN OPENED AVANOS ON-Q ANTIMICROBIAL EXPANSION KIT TO STERILE BACK TABLE. RN HOLDING KIT OPEN FOR SCRUB TECH TO GRAB SUPPLIES. ANOTHER RN REPORTED HEARING "POP" SOUND AND THE SHEATHED INTRODUCER IN PACKAGE SLING-SHOTTED OUT OF PACKAGE INTO THE FIRST RN'S EYE. RN USED EYEWASH STATION AND EXAMINED EYE. MILD PAIN PRESENT BUT NO OTHER INJURIES NOTED.
Patient problems: Eye Pain
MAUDE report 22885309 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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