Wheelchair, Mechanical
FDA adverse event reports and recall history for wheelchair, mechanical (product code IOR), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 25,876
- Deaths
- 54
- Injuries
- 1,052
- Malfunctions
- 22,835
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2016-07-25TerminatedDevice Design
Quickie Q7 wheelchair. Model EIR4 Physical Medicine. The Quickie Q7 series of wheelchair's intended use is to provide mobility to persons limited to a sitting position.
There is an observed failure of the backrest bracket which can fatigue over the life time of the product. When this occurs there is the possibility of the bracket fracturing causing the backrest to detach from the chair frame.
- 2015-08-26TerminatedDevice Design
Zippie IRIS Wheelchair. model EIZ5A in combination with option code 188M02 - MONO Backrest system with Dynamic Backrest option. Provide mobility to persons limited to a sitting position.
Quickie IRIS and Zippie IRIS tilt-in-space wheelchairs with MONO Backrest System with Dynamic Backrest may break over time resulting in a fall or injury to occupant.
- 2015-08-26TerminatedDevice Design
Quickie IRIS Wheelchair. model EIZ4-2 in combination with option code 183M02 - MONO Backrest system with Dynamic Backrest option. Provide mobility to persons limited to a sitting position.
Quickie IRIS and Zippie IRIS tilt-in-space wheelchairs with MONO Backrest System with Dynamic Backrest may break over time resulting in a fall or injury to occupant.
- 2015-01-27TerminatedDevice Design
Zippie Zone Pediatric Rigid Wheelchair Model EIRZ1.
There is the potential for the height adjustable handle to dislodge due to failing locking mechanisms on specific identified chairs.
- 2015-01-27TerminatedDevice Design
Quickie Q7 Adult Rigid Wheelchair Model EIR4.
There is the potential for the height adjustable handle to dislodge due to failing locking mechanisms on specific identified chairs.
- 2014-12-16TerminatedNonconforming Material/Component
Crocodile (size 3) are two-armed, wheeled walking aids, used by children with disabilities. Product Usage: The Crocodile is a walking aid for children with disabilities, who need supplementary assistance with their daily walking. The Crocodile is available in three sizes and can be used for children between the ages of 2 to 18 years.
The bolts, which secure the handles, on the Crocodile (size 3) could break, causing the handle to dislodge.
- 2014-11-14TerminatedDevice Design
Transport Chair and Rollator in 1, Model HE21630011 Burgundy and HE21630011 Blue. This is a walker/rolling chair. Used to assist injured and infirm people to walk or be ambulatory.
Silver Star Brands is recalling the Transport Chair and Rollator in One because they have received several reports of the wheel assembly failing resulting in damaged wheels..
- 2014-09-24TerminatedComponent design/selection
Fuze Manual Tilt Wheelchair. Fuze T50, Fuze T20 and Fuze T50 Jr
The hex bolt head might shear and cause the axle plate to detach from the lower frame of the wheelchair and could collapse the wheels while in use.
- 2014-01-08TerminatedComponent design/selection
Tracer IV wheelchairs, Heavy duty manual wheel chair, 24" seat width, 450 lbs. weight capacity. Distributed by Invacare, Elyria, OH 44035 For transportation to accomplish necessary tasks of daily living in a home or community environment for the user.
The wheels on Tracer IV wheelchairs (Tracer IV 24" seat width, 450 lbs. weight capacity manual wheel chair) were warped and wobbled when rolled.
- 2013-12-05TerminatedNonconforming Material/Component
Sunrise Brand Zippie Voyage, Chair with Casters, Early Intervention Device (Stroller), Model: EIZ14; Product is manufactured and distributed by Sunrise Medical (US) LLC., Fresno, CA. Used by a person to move from one place to another while sitting.
There is a remote possibility for the plastic latch to deform over the lifetime of use. When this happens there is the possibility for the seat to become dislodged from the base. And when not using the positioning strap, there is a risk that the occupant could slide out of the seat and sustain injury.
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