Guardian K3206N24SRecalls & reported problems
Medline Industries, Inc. · WHEELCHAIR, K3, 20", SB DDLA, SA FOOT · Class 1
Quick summary
This Medline Guardian K3 wheelchair is a manual wheelchair. Reports mostly describe fractures, with some parts detaching or splitting; one report says the drive wheel arrived broken. There are 24 adverse event reports, with no deaths or injuries, and no recalls name this device. All 24 reports were in the latest 12-month period, compared with 0 in the previous 12 months.
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
- 9
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00193489087164), received between May 6, 2026 and Sep 30, 2026 — classified as 9 malfunctions.
The most frequently reported specific device problem is “Fracture” (4 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Fracture4
- Material Twisted/Bent4
- Detachment of Device or Device Component2
- Component Missing1
Patient problems
- No Clinical Signs, Symptoms or Conditions9
Recent adverse event reports
The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Detachment of Device or Device Component; Material Twisted/Bent
It was reported that "TIRES ARE WORN OFF, RIGHT WHEEL IS COMING OFF, BENT, NOT SAFE TO USE."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50946505 ↗MalfunctionSep 29, 2026Component Missing
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50935477 ↗MalfunctionSep 29, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50934270 ↗MalfunctionSep 28, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50922828 ↗MalfunctionSep 28, 2026Material Twisted/Bent
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50921115 ↗MalfunctionSep 28, 2026Material Twisted/Bent
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50917586 ↗MalfunctionSep 24, 2026Fracture; Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50889095 ↗MalfunctionAug 13, 2026Material Twisted/Bent
It was reported that upon removal from the box, the frame would not go into the brackets when the seat was extended outward.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50239404 ↗MalfunctionMay 6, 2026Fracture
IT WAS REPORTED THAT THE CUSTOMER "HEARD AND FELT A POP WHEN SITTING DOWN INTO THE CHAIR THEN NOTICED THE LEFT REAR WHEEL PINNED AGAINST THE LEFT ARMREST ASSEMBLY."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25100585 ↗
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
- MEDLINE K3186N34SMedline Industries, Inc. · Wheelchair, mechanical9 reports
- MEDLINE KX228V21EMedline Industries, Inc. · Wheelchair, mechanical9 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.