Agency classClass IIOur severity:High FDA (Devices)·Z-1315-2019·Announced 2019-05-22

R82 Wombat Living Activity Chair Recalled for Plastic Joint Breakage

R82 A/S is recalling 68 Wombat Living activity chairs (wheelchairs) in North Carolina due to reports of the plastic joint connecting the back to the seat breaking.

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a structural defect in a mobility device (wheelchair) where breakage is reported, posing a risk of harm, but no specific injuries or fatalities are mentioned in the source text.

Plain-English summary

R82 A/S is recalling 68 units of the Wombat Living activity chair (wheelchair), Size 3, in the United States. The affected units were distributed in North Carolina. The recall involves specific item numbers and serial numbers listed in the agency's official record.

The recall was initiated after the firm received feedback from the market regarding the breakage of the plastic joint that connects the back of the chair to the seat. This defect could potentially compromise the structural integrity of the wheelchair.

Consumers who possess one of the affected Wombat Living activity chairs should stop using the product immediately. They should contact R82 A/S for further instructions on how to resolve the issue.

The recalled product

Product: Wombat Living, Size 3, Item Numbers: 953121-00, 953126-00, 953131-00, 953132-00, 935-135-00, 935136-00, 953211-00, 953221-00, 953222-00, 953225-00, 953226-00, 953231-001, 953232-00, 953236-00 Product Usage: Activity chair (wheelchair)
Manufacturer: R82 A/S
Category: Medical Device — Mobility Aids
Hazard: structural-failure
Affected units: 68

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 (20)

953121-00
Serial Numbers: 396362
408283
420577 953126-00
Serial Numbers: 388456 953131-00
Serial Numbers: 458258 953132-00
Serial Numbers: 384942
385290
388501
418621 935135-00
Serial Numbers: 424406
424407
424990
424991
427314
427315
427316
427317
427318
427319 935136-00

Distribution

Distributed in 1 state:

Same manufacturer · R82 A/S

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Same hazard · structural failure