Guardian K3206N34SRecalls & reported problems
Medline Industries, Inc. · WHEELCHAIR, K3, 20", SB HARDLA, SA FOOT · Class 1
All models of Guardian (15)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This is a Medline Guardian K3 lightweight wheelchair. The 26 reports filed in the past year mostly describe frame and wheel problems: spokes and wheels cracking or breaking, bent or twisted frame parts, and a footrest hook that would not lock in place. One report describes a fall; there were no deaths. All of these reports are new, with none filed in the previous 12 months, and no recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00193489083715), received between May 8, 2026 and Sep 29, 2026 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Fracture” (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
- Fracture2
- Material Separation2
- Detachment of Device or Device Component1
- Material Twisted/Bent1
- Mechanical Jam1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
OtherSep 29, 2026Fracture; Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50940625 ↗MalfunctionSep 23, 2026Mechanical Jam
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50874438 ↗MalfunctionAug 11, 2026Fracture; Material Twisted/Bent
It was reported that "The right tire is rubbing against the frame of the chair."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50209323 ↗MalfunctionMay 15, 2026Material Separation
IT WAS REPORTED THAT THE RUBBER ON THE WHEEL CAME OFF WHILE IN USE. THE TREAD DETACHED FROM THE FRONT WHEEL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25191316 ↗MalfunctionMay 8, 2026Material Separation
IT WAS REPORTED THAT THE RUBBER ON THE RIGHT REAR WHEEL OF THE CHAIR CAME OFF WHILE IN USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25125462 ↗
Other Wheelchair, mechanical devices
- MEDLINE K1186N22SMedline Industries, Inc. · Wheelchair, mechanical48 reports
- Guardian K4186N24EMedline Industries, Inc. · Wheelchair, mechanical22 reports
- MEDLINE INDUSTRIES, INC. MDS808650Medline Industries, Inc. · Wheelchair, mechanical18 reports
- Medline MDS806850Medline Industries, Inc. · Wheelchair, mechanical17 reports
- Guardian K3186N24EMedline Industries, Inc. · Wheelchair, mechanical10 reports
- Quickie 7 SeriesSunrise Medical (US) LLC · Wheelchair, Mechanical1 death10 reports
- Guardian K3206N24SMedline Industries, Inc. · Wheelchair, mechanical9 reports
- MEDLINE KX228V21EMedline Industries, Inc. · Wheelchair, mechanical9 reports
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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