GuardianRecalls & reported problems across all models
Medline Industries, Inc. · 15 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 77
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls
- 0
We found 15 models of Guardian by Medline Industries, Inc. in the FDA's device registry (GUDID). Together they are named in 77 adverse event reports in the FDA's MAUDE database, received between Aug 18, 2022 and Sep 30, 2026 — classified as 2 injuries, 74 malfunctions.
The most frequently reported specific device problem is “Fracture” (33 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Guardian problems
Device problems
- Fracture33
- Material Twisted/Bent13
- Detachment of Device or Device Component6
- Activation Problem4
- Material Separation4
- Break3
- No Apparent Adverse Event3
- Material Split, Cut or Torn2
Patient problems
- No Clinical Signs, Symptoms or Conditions69
- Fall4
- Insufficient Information2
- Laceration(s)2
- Bruise/Contusion1
- Limb Pain1
- Pain1
- Swelling/ Edema1
Guardian models
15 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Guardian K4186N24EWheelchair, mechanical22 reports
- Guardian K3186N24EWheelchair, mechanical10 reports
- Guardian K3206N24SWheelchair, mechanical9 reports
- Guardian MDS868BTRBCHAIR, WITH CASTERS8 reports
- Guardian K4206N24EWheelchair, mechanical7 reports
- GUARDIAN G1-503WCPX1CHAIR, WITH CASTERS5 reports
- Guardian K3206N34SWheelchair, mechanical5 reports
- Guardian K3166N24SWheelchair, mechanical2 reports
- Guardian K4166N24EWheelchair, mechanical2 reports
- Guardian K4166N24SWheelchair, mechanical2 reports
- Guardian KPD4N22S1Wheelchair, mechanical1 report
- Guardian K3166N44SWheelchair, mechanical1 report
- Guardian K4186N24SWheelchair, mechanical1 report
- Guardian K4206N24SWheelchair, mechanical1 report
- GUARDIAN KPD4N22SWheelchair, Mechanical1 report
Recent Guardian adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Fracture
Patient problems: Fall
MAUDE report 50950854 ↗MalfunctionSep 30, 2026Fracture
It was reported that ¿The seat has a bent crease in the middle due to the way this is being packaged.¿
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50947618 ↗MalfunctionSep 30, 2026Detachment of Device or Device Component; Material Twisted/Bent
It was reported that "TIRES ARE WORN OFF, RIGHT WHEEL IS COMING OFF, BENT, NOT SAFE TO USE."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50946505 ↗MalfunctionSep 30, 2026Retraction Problem
It was reported that "Wheelchair to adjust the unit wouldn't release the quick release axel so he tapped it with the hammer to adjust it. Customer is not unable to move the axel due to this, and rear right wheel is stuck."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50946021 ↗MalfunctionSep 30, 2026Activation Problem
It was reported that "The legrests will no longer lower to be stored. They are stuck in the up position.".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50945582 ↗OtherSep 29, 2026Fracture; Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50940625 ↗MalfunctionSep 29, 2026Material Twisted/Bent
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50938013 ↗MalfunctionSep 29, 2026Fracture
Patient problems: Fall; Pain
MAUDE report 50937686 ↗MalfunctionSep 29, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50936660 ↗MalfunctionSep 29, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50936363 ↗MalfunctionSep 29, 2026Fracture; Mechanical Problem
Customer states the armrests have stripped screws and the brakes are not holding on both sides.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50936343 ↗MalfunctionSep 29, 2026Component Missing
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50935477 ↗MalfunctionSep 29, 2026Positioning Failure; Activation Failure
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50934758 ↗MalfunctionSep 29, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50934270 ↗MalfunctionSep 29, 2026Fracture; Material Twisted/Bent
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50933216 ↗
Other Medline Industries, Inc. products
- Centurion Medical Products Corp52 models · 10 reports · 32 recalls
- NAMIC667 models · 229 reports · 22 recalls
- CURAD85 models · 295 reports · 4 recalls
- HUDSON RCI30 models · 190 reports · 2 recalls
- Excelsior8 models · 47 reports · 3 recalls
- BAUSCH and LOMB6 models · 1 reports · 2 recalls
- Medline ReNewal18 models · 34 reports · 1 recall
- MEDLINE UNITE10 models · 9 reports · 1 recall
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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