Medline MDS806250EVRecalls & reported problems

Medline Industries, Inc. · WHEELCHAIR, VINYL, DLR, S/A, K2B, 18" · Class 1

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

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 1
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00884389830041), received between May 20, 2025 and May 20, 2025 — classified as 1 injury.

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

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Appropriate Device Problem Term/Code Not Available1

Patient problems

Bone Fracture(s)1
Hip Fracture1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

InjuryMay 20, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
WHEELCHAIR NOT LOCKING.
Patient problems: Bone Fracture(s); Hip Fracture
MAUDE report 22055360 ↗

Device details

UDI-DI	`00884389830041`
Brand	Medline
Model	MDS806250EV
Company	Medline Industries, Inc.
Product code	IOR · Wheelchair, mechanical
Class	Class 1
FDA submission	K990463
Implant	No
Rx / OTC	OTC
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Dec 18, 2023

Device type (GMDN): Wheelchair, power-assisted, occupant-controlled, collapsible

A wheeled personal mobility device that incorporates a seat-support system for a person with a disability or a person without the full capacity to walk (not bariatric) designed to be manually propelled and steered by the rotation of both rear wheels by the occupant, and when needed, power from an electric motor replaces manual wheel rotation. The device may be disassembled or folded for transport. Typically, the user is a paraplegic or quadriparetic person who desires to manually propel himself as much as possible for the exercise. The power assist feature is enabled to climb inclines, for extended distance travel, or when the user fatigues.

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All Wheelchair, mechanical devices →

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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