The Recall Desk
Agency classClass IIOur severity:SevereFDA (Devices)·Z-2695-2014·Announced 2014-10-01

PDG Fuze Manual Tilt Wheelchairs Recalled for Axle Plate Detachment Risk

PDG Product Design Group is recalling Fuze T50, T20, and T50 Jr manual tilt wheelchairs because a hex bolt head might shear, causing the axle plate to detach and the wheels to collapse.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall involves a structural vehicle defect (wheelchair axle plate detachment) that could cause the wheels to collapse while in use, meeting the criteria for a Severe rating under the rubric for structural defects or significant injury risks.

Plain-English summary

PDG Product Design Group Inc is recalling 153 units of the Fuze Manual Tilt Wheelchair, specifically the Fuze T50, Fuze T20, and Fuze T50 Jr models. The recall is due to a defect where the hex bolt head might shear, which could cause the axle plate to detach from the lower frame of the wheelchair. This failure could result in the wheels collapsing while the wheelchair is in use.

The affected units were distributed worldwide, including in the United States (AZ, CA, GA, KY, MI, MN, MO, MS, NC, NE, NY, OH, PA, SC, TX, VA, and WA) and internationally to Canada and Hong Kong. The recall is classified as Class II by the FDA.

Consumers should stop using the affected wheelchairs immediately and contact PDG Product Design Group Inc for instructions on how to resolve the issue. The specific serial numbers affected are listed in the agency's recall documentation.

The recalled product

Product
Fuze Manual Tilt Wheelchair. Fuze T50, Fuze T20 and Fuze T50 Jr
Manufacturer
Pdg Product Design Group Inc
Category
Medical Device — Mobility Aids
Hazard
Affected units
153

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Fuze T50

Distribution

Distributed in 17 states:

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