Guardian K3166N24SRecalls & reported problems

Medline Industries, Inc. · WHEELCHAIR, K3, 16", SB DDLA, SA FOOT · Class 1

All models of Guardian (15)

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

Adverse event reports: 2
Deaths reported: 0
Injuries reported: 1
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00193489087126), received between Aug 18, 2022 and Aug 13, 2026 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Material Twisted/Bent” (1 report).

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

Material Twisted/Bent1
Scratched Material1

Patient problems

Laceration(s)1
No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

MalfunctionAug 13, 2026Material Twisted/Bent
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50236037 ↗
InjuryAug 18, 2022Scratched Material
ACCORDING TO THE CUSTOMER ON (B)(6) 2022 HER MOTHER WAS RIDING IN THE CAR AND WHEN ATTEMPTING TO GET OUT AND SIT IN THE WHEELCHAIR A 'ROUGH PIECE OF METAL ON THE WHEELCHAIR GAUGED A DEEP WOUND ON THE LOWER RIGHT LEG'. PER THE CUSTOMER THE INJURY REQUIRED MULTIPLE WOUND CARE VISITS AND HOME HEALTH.
Patient problems: Laceration(s)
MAUDE report 15256298 ↗

Device details

UDI-DI	`00193489087126`
Brand	Guardian
Model	K3166N24S
Company	Medline Industries, Inc.
Product code	IOR · Wheelchair, mechanical
Class	Class 1
FDA submission	None listed
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): Push-rim manual wheelchair, non-bariatric

A non-powered wheeled personal mobility device with a seat designed to enable a non-bariatric person with a disability, or without the full capacity to walk, to self-mobilize by pushing specially designed rims on the wheels while seated. It is designed with a pair of larger wheels with push-rims attached whereby the occupant propels the device by rotating both wheels; it typically includes rear-fitted handles designed for optional pushing by an attendant. It provides no function outside of wheeled mobilization.

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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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