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Guardian K3186N24ERecalls & reported problems

Medline Industries, Inc. · WHEELCHAIR, K3, 18", SB DDLA, ELR FOOT · Class 1

All models of Guardian (15)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
10
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00193489087133), received between May 3, 2026 and Sep 30, 2026 — classified as 10 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 2 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 1 reportsSep 2026: 7 reportsOct 2026: 0 reports2024202520267
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Fracture4
  • Activation Problem2
  • Mechanical Problem2
  • Loose or Intermittent Connection1
  • Material Separation1
  • Material Split, Cut or Torn1
  • Material Twisted/Bent1
  • No Apparent Adverse Event1

Patient problems

  • No Clinical Signs, Symptoms or Conditions9
  • Fall1
  • Pain1

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

  • MalfunctionSep 30, 2026Activation Problem

    It was reported that "The legrests will no longer lower to be stored. They are stuck in the up position.".

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50945582 ↗
  • MalfunctionSep 29, 2026Fracture

    Patient problems: Fall; Pain

    MAUDE report 50937686 ↗
  • MalfunctionSep 29, 2026Fracture; Mechanical Problem

    Customer states the armrests have stripped screws and the brakes are not holding on both sides.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50936343 ↗
  • MalfunctionSep 29, 2026Fracture; Material Twisted/Bent

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50933216 ↗
  • MalfunctionSep 28, 2026Activation Problem

    It was reported that the legrests are stuck in the upright position and cannot be lowered.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50915838 ↗
  • MalfunctionSep 25, 2026Loose or Intermittent Connection; Material Split, Cut or Torn

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50903037 ↗
  • MalfunctionSep 17, 2026Fracture

    It was reported that the footrest cracked.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50803850 ↗
  • MalfunctionAug 13, 2026Material Separation

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50241664 ↗
  • MalfunctionMay 3, 2026No Apparent Adverse Event

    THE CUSTOMER STATED "THE BACK WHEEL ARRIVED WITH A BROKEN SPOKE".

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25062580 ↗
  • MalfunctionMay 3, 2026Mechanical Problem

    IT WAS REPORTED THAT THE WHEELCHAIR HAS A DEFECTIVE LEG REST, AND THE RELEASE MECHANISM FOR LOWERING THE LEG DOES NOT FUNCTION. THE CUSTOMER ALSO REPORTED A DAMAGED SPOKE AND A DISENGAGED HANDBRAKE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25062472 ↗

Other Wheelchair, mechanical devices

All Wheelchair, mechanical devices →

Sources and updates

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