Medline MDS806550FLARecalls & reported problems
Medline Industries, Inc. · WHEELCHAIR,18",FLA,ELR · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- 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 00080196739588), received between Jun 17, 2026 and Sep 29, 2026 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Mechanical Problem” (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. 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
- Mechanical Problem2
- Activation Failure1
- Component Misassembled1
- Difficult or Delayed Activation1
- Fracture1
- No Apparent Adverse Event1
- Product Quality Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions6
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Product Quality Problem; Difficult or Delayed Activation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50936146 ↗MalfunctionSep 29, 2026Fracture
It was reported that the wheelchair "HAD A SUPPORT BAR SNAP IN HALF."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50933044 ↗MalfunctionSep 28, 2026Mechanical Problem
It was reported that "the L arm that goes up and down it does not lock into place.".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50917256 ↗MalfunctionSep 24, 2026Activation Failure; Component Misassembled
It was reported that "The left armrest will not lock into place when they lower it on the wheelchair."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50884660 ↗MalfunctionJun 19, 2026No Apparent Adverse Event
IT WAS REPORTED THAT THE ARMS ON THE WHEELCHAIR WENT UP AND CUSTOMER TILTED FORWARD WHILE. CUSTOMER STATES THE PUSH BUTTONS ARE NO LONGER WORKING TO LOCK THE ARMS ON THE WHEELCHAIR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25566460 ↗MalfunctionJun 17, 2026Mechanical Problem
IT WAS REPORTED "THE RIGHT WHEEL LOCK IS NOT LOCKING" AND "THE SCREWS FELLS OUT OF THE ARMREST".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25541130 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page