Reported Mar 26, 2014 · Terminated

Otto Bock Aerial and Aerial Active Wheelchair Cushions. Material numbers: SK757 476C00=SK701, 476C00=SK702,…

Bock,Otto,Orthopedic Ind,Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Bock,Otto,Orthopedic Ind,Inc · Two Carlson Parkway North, Suite 100 · Minneapolis, MN · 55447

Is this the product you have?

  • 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
    • 476C00=SK753
    • 476C00=SK754
    • 476C00=SK755
    • 476C00=SK756
    • 476C00= SK757
Lot codes and dates
  • 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
Amount recalled
464 units (US 113, OUS 351)

Where it was sold

  • Nationwide

Why it was recalled

Otto Bock is recalling all Aerial and Aerial Active Wheelchair Cushions from specific material numbers. During internal testing, it was discovered that there is a small risk of flammability to the cushion after it has been washed at high temperatures. The cushions should either be returned to Otto Bock or destroyed.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated May 7, 2018 · Data as of Sep 19, 6:51 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.