FDAOctober 10, 2018device

Naera Hospital Bassinet, Model No. 4402

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

It was identified that the volume of air inside the mattress may expand in regions of high altitude which may result in an unintended gap between the plateau of the inflated patient surface and tub. A Health Hazard Evaluation was completed which identified the potential risk of patients moving out of position and rolling over on the mattress. While the highest possible severity of harm associated with this condition is death, there have been no reports of injury or harm. This condition has only presented in regions of high altitude; however, Stryker has chosen to replace all Naera mattresses in the field.

What to do

FDA enforcement status: Terminated

Brands named

stryker medical divisionstrykerstryker medical

UPCs

201600060000320160006000042016000600005201600060000620160006000072016000600008201600060000920160006000102016000600011201600060001220160006000132016000600014

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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