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MEDLINE KX228V21SRecalls & reported problems

Medline Industries, Inc. · WHEELCHAIR, XW, 22", RDLA, SA · Class 1

Adverse event reports
6
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00193489179920), received between May 14, 2026 and Sep 30, 2026 — classified as 6 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

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: 0 reportsSep 2026: 4 reportsOct 2026: 0 reports2024202520264
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Fracture4
  • Material Twisted/Bent1
  • No Apparent Adverse Event1

Patient problems

  • No Clinical Signs, Symptoms or Conditions5
  • Fall1

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

  • MalfunctionSep 30, 2026Fracture

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50951243 ↗
  • MalfunctionSep 28, 2026Material Twisted/Bent

    It was reported that "Brakes are no longer working."

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50914516 ↗
  • MalfunctionSep 25, 2026Fracture

    It was reported that while the end user was using the chair the R "rim" rear wheel spokes broke near the center hub causing the end user to fall to the ground.

    Patient problems: Fall

    MAUDE report 50897727 ↗
  • MalfunctionSep 25, 2026Fracture

    It was reported that after unboxing unit noticed the L rear wheel spoke is broken by the rear axle.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50897304 ↗
  • MalfunctionMay 20, 2026Fracture

    IT WAS REPORTED WHILE CUSTOMER WAS IN THE WHEELCHAIR, HE STOPPED AND APPLIED THE BRAKES, WHICH THEN FELL OFF.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25229109 ↗
  • MalfunctionMay 14, 2026No Apparent Adverse Event

    CUSTOMER STATED "THE TREAD IS COMING OFF THE REAR LEFT WHEEL OF THE WHEELCHAIR".

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25167575 ↗

Other Wheelchair, mechanical devices

All Wheelchair, mechanical devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.