The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1266-2014·Announced 2014-03-26

Otto Bock Recalls Aerial Wheelchair Cushions Due to Flammability Risk

Otto Bock is recalling Aerial and Aerial Active wheelchair cushions because internal testing found a small risk of flammability after high-temperature washing.

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 risk-of-harm product (flammability) where injury has not yet been reported, which aligns with the 'High' severity criteria in the rubric.

Plain-English summary

Otto Bock is recalling all Aerial and Aerial Active Wheelchair Cushions with specific material numbers. The recall affects 464 units, with 113 distributed in the United States and 351 distributed internationally.

During internal testing, Otto Bock discovered that there is a small risk of flammability to the cushion after it has been washed at high temperatures. The affected material numbers include SK701 through SK707. Several other material numbers were not distributed within the US.

Consumers should return the affected cushions to Otto Bock or destroy them. The recall is classified as Class II by the FDA.

The recalled product

Product
Otto Bock Aerial and Aerial Active Wheelchair Cushions. Material numbers: SK757 476C00=SK701, 476C00=SK702, 476C00=SK703, 476C00=SK704, 476C00=SK705, 476C00=SK706, 476C00=SK707, The following material numbers were not distributed within the US: 476C00=SK751, 476C00=SK752…
Manufacturer
Bock,Otto,Orthopedic Ind,Inc
Category
Medical Device — Wheelchair Cushions
Hazard

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 (14)

  • all cushions with the following material numbers: SK757 476C00=SK701
  • 476C00=SK702
  • 476C00=SK703
  • 476C00=SK704
  • 476C00=SK705
  • 476C00=SK706
  • 476C00=SK707
  • The following material numbers were not distributed within the US: 476C00=SK751
  • 476C00=SK752
  • 476C00=SK753
  • 476C00=SK754
  • 476C00=SK755
  • 476C00=SK756
  • 476C00= SK757.

Distribution

Distributed nationwide across the United States.

Related recalls

Same hazard · fire

See all →

Similar recalls