Guardian K4206N24ERecalls & reported problems
Medline Industries, Inc. · WHEELCHAIR, K4, 20", SB DDLA, ELR FOOT · Class 1
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00193489099754), received between May 29, 2026 and Sep 29, 2026 — classified as 7 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Fracture2
- Material Twisted/Bent2
- Activation Failure1
- Break1
- No Apparent Adverse Event1
- Positioning Failure1
Patient problems
- No Clinical Signs, Symptoms or Conditions6
- Insufficient Information1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Positioning Failure; Activation Failure
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50934758 ↗MalfunctionSep 25, 2026Material Twisted/Bent
It was reported that "the right axel got bent" and "the whole wheel being bent."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50896296 ↗MalfunctionSep 24, 2026Fracture
It was reported that "The wheelchair right legrest bracket is broken. Stated that where the bracket is the weld came undone."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50882137 ↗MalfunctionSep 23, 2026No Apparent Adverse Event
It was reported that the armrests do not go all the way out to the front.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50870315 ↗MalfunctionSep 23, 2026Fracture
It was reported that "the spoke on the back right wheel cracked."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50868088 ↗MalfunctionJun 15, 2026Material Twisted/Bent
IT WAS REPORTED THAT UPON DELIVERY THE RIGHT WHEEL LOCK IS BENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25503019 ↗MalfunctionMay 29, 2026Break
IT WAS REPORTED THAT THE "HANDLE SNAPPED OFF WHERE THE HANDLE ENTERS THE FRAME".
Patient problems: Insufficient Information
MAUDE report 25337820 ↗
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
- Guardian K3206N24SMedline 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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