Guardian K4186N24ERecalls & reported problems
Medline Industries, Inc. · WHEELCHAIR, K4, 18", SB DDLA, ELR FOOT · Class 1
All models of Guardian (15)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This is a Medline Guardian manual wheelchair. Most of the 52 reports describe the frame breaking, along with parts coming loose, jamming, and the chair becoming unstable or twisted; a few mention falls and a cut. There are no deaths and 1 injury, and no recalls name this device. Reports rose sharply, from 1 in the previous 12 months to 51 in the most recent one.
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
- 22
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00080196306117), received between Aug 25, 2025 and Sep 30, 2026 — classified as 1 injury, 21 malfunctions.
The most frequently reported specific device problem is “Fracture” (8 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Fracture8
- Activation Problem2
- Detachment of Device or Device Component2
- Material Twisted/Bent2
- Component Misassembled1
- Difficult or Delayed Activation1
- Difficult to Fold, Unfold or Collapse1
- Failure to Align1
Patient problems
- No Clinical Signs, Symptoms or Conditions19
- Fall1
- Insufficient Information1
- Laceration(s)1
Recent adverse event reports
The 22 most recent of 22 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Fracture
Patient problems: Fall
MAUDE report 50950854 ↗MalfunctionSep 30, 2026Retraction Problem
It was reported that "Wheelchair to adjust the unit wouldn't release the quick release axel so he tapped it with the hammer to adjust it. Customer is not unable to move the axel due to this, and rear right wheel is stuck."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50946021 ↗MalfunctionSep 29, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50936363 ↗MalfunctionSep 29, 2026Mechanical Jam
It was reported that "The right legrest lever is broken off and is stuck in the elevated position."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50932395 ↗MalfunctionSep 29, 2026Activation Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50932055 ↗MalfunctionSep 28, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50925017 ↗MalfunctionSep 28, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50920650 ↗MalfunctionSep 28, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50917661 ↗MalfunctionSep 25, 2026Fracture
It was reported that "there was noted to be a broken L wheel upon receipt."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50895845 ↗MalfunctionSep 24, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50890139 ↗MalfunctionSep 24, 2026Activation Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50890109 ↗MalfunctionSep 24, 2026Difficult or Delayed Activation
It was reported that "the brakes are too tight and it takes two hand to lock and unlock them."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50886549 ↗MalfunctionSep 24, 2026Fracture
It was reported that one of the welds for the right footrest is fractured.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50886020 ↗MalfunctionSep 23, 2026Component Misassembled
It was reported that ¿the legrest are inverted on both sides of the wheelchair. Customer informed his wife was being transported to physical therapy when she noticed the issue¿.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50872081 ↗MalfunctionJul 6, 2026Material Twisted/Bent
IT WAS REPORTED THAT"ONE OF THE LEGRESTS IS BENT".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25715699 ↗MalfunctionJul 2, 2026Failure to Align
IT WAS REPORTED THAT THE LEGREST IS NOT FITTING INTO THE INSERT. CUSTOMER IS SAYING IT TAKES A LOT OF FORCE TO INSERT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25696813 ↗MalfunctionJul 2, 2026Difficult to Fold, Unfold or Collapse; Structural Problem
IT WAS REPORTED THAT "THE LEGREST LOCK IS MISALIGNED AND WILL NOT LOCK PROPERLY. THE END USER'S PRIMARY CAREGIVER IS UNAWARE OF HOW OR WHEN THIS HAPPENED".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25695189 ↗MalfunctionJul 2, 2026Material Twisted/Bent
IT WAS REPORTED THAT "A PIECE OF METAL THAT IS LOOSE AND THE FOOT REST IS SWINGING, AND THE RIGHT BRAKE IS TIGHTER THAN THE LEFT BRAKE".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25693642 ↗MalfunctionJul 2, 2026Fracture
IT WAS REPORTED THAT "PER CALL, CUSTOMER NEEDS FRONT AND REAR RECEIVER PER PRODUCT SUPPORT. CUSTOMER INFORMED BOTH ARE FRACTURED ON BOTH LEFT AND RIGHT SIDE."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25692416 ↗MalfunctionJun 4, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT THE "WHEELCHAIR LEGREST IS BROKEN AND WELD CAME UNDONE ON THE RIGHT LEGREST BRACKET THAT CONNECTS TO THE CHAIR".
Patient problems: Insufficient Information
MAUDE report 25400256 ↗MalfunctionMay 3, 2026No Apparent Adverse Event
THE CUSTOMER STATED, "A PLASTIC CASING THAT ALLOWS THE ARM REST TO SECURE TO THE BASE OF THE WHEELCHAIR WHICH HAS SNAPPED".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25062573 ↗InjuryAug 25, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
Other Wheelchair, mechanical devices
- MEDLINE K1186N22SMedline Industries, Inc. · Wheelchair, mechanical48 reports
- MEDLINE INDUSTRIES, INC. MDS808650Medline Industries, Inc. · Wheelchair, mechanical18 reports
- Medline MDS806850Medline Industries, Inc. · Wheelchair, mechanical17 reports
- Quickie 7 SeriesSunrise Medical (US) LLC · Wheelchair, Mechanical1 death10 reports
- Guardian K3186N24EMedline Industries, Inc. · Wheelchair, mechanical10 reports
- Guardian K3206N24SMedline Industries, Inc. · Wheelchair, mechanical9 reports
- MEDLINE K3186N34SMedline 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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