MEDLINE K3166N34ERecalls & reported problems
Medline Industries, Inc. · WC, K3, 16", SB HARDLA, ELR · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 8
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00193489083661), received between May 3, 2026 and Sep 30, 2026 — classified as 8 malfunctions.
The most frequently reported specific device problem is “Fracture” (3 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
Most reported problems
Device problems
- Fracture3
- Activation Problem1
- Crack1
- Mechanical Problem1
- No Apparent Adverse Event1
- Unstable1
Patient problems
- No Clinical Signs, Symptoms or Conditions8
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Activation Problem
It was reported that "wheelchair right side arm rest was elevated and now it will not good down; it seems as though it is locked into it's elevated position."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50945725 ↗MalfunctionSep 29, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50932589 ↗MalfunctionSep 28, 2026Fracture
It was reported that "The frame broke above the left wheel axle when the end user was in the wheelchair."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50917023 ↗MalfunctionSep 23, 2026Fracture
It was reported that "spoke is broken on wheel."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50872750 ↗MalfunctionAug 12, 2026Unstable
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50227757 ↗MalfunctionAug 11, 2026Mechanical Problem
It was reported that the armrests are no longer working and the left wheel lock is no longer working.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50208423 ↗MalfunctionMay 13, 2026Crack
ACCORDING TO THE CUSTOMER, THE RIGHT, REAR WHEEL IS CRACKED ON THE WHEELCHAIR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25164948 ↗MalfunctionMay 3, 2026No Apparent Adverse Event
CUSTOMER STATED "WHEELCHAIR REAR WHEELS ARE WOBBLY WHEN HE TURNS IT FEELS LIKE SOMETHING IS MOVING INSIDE THE BEARINGS."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25063852 ↗
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
- Guardian K3206N24SMedline 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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