Z-1266-2014Class II

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

Name: Z-1266-2014 Otto Bock Aerial and Aerial Active Wheelchair Cushions. Material numbers: SK757 476C00=SK701, 476C00=SK702...
Creator: Bock,Otto,Orthopedic Ind,Inc
Published: 2014-01-31
License: https://open.fda.gov/license/

Bock,Otto,Orthopedic Ind,Inc / initiated 2014-01-31 / Terminated

FDA source

Bock,Otto,Orthopedic Ind,Inc began a recall of Otto Bock Aerial and Aerial Active Wheelchair Cushions. Material numbers: SK757 476C00=SK701, 476C00=SK702, 476C00=SK703, 476C00=SK704, 476C00=SK705... on 2014-01-31. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1266-2014
Classification: Class II
Status: Terminated
Initiated: 2014-01-31
Posted: 2014-03-21
Terminated: 2018-05-07
Recalling firm: Bock,Otto,Orthopedic Ind,Inc
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, 476C00=SK753, 476C00=SK754, 476C00=SK755, 476C00=SK756, 476C00= SK757.
Product code: IMP Cushion, Wheelchair
Reason for recall: 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.
FDA root cause: Unknown/Undetermined by firm
Action: An Urgent Voluntary Device Recall letter was sent to customers beginning 1/31/2014. The letter identified the affected material numbers, described the reason for recall, and asked that product be returned or destroyed. A response Questionnaire was asked to be completed and returned.
Quantity in commerce: 464 units (US 113, OUS 351)
Distribution: Worldwide Distribution-USA (nationwide) and the countries of Australia, Austria, Bosnia and Herzegovina, Brazil, China, Columbia, Croatia, Denmark, France, Germany, Greece, Hong Kong, Hungary, Iceland, Japan, Mexico, Netherlands, Poland, Romania, Russia, South Africa, Spain, Sweden, Switzerland, Thailand, and United Kingdom.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1266-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1266-2014	Class II	Terminated	Voluntary: Firm initiated	2014-03-26	2014-03-20

Product code IMP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)