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FDASeptember 29, 2016device

8500M Handheld Pulse Oximeter

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

The hazard

Nonin manufactures and sells two 8500 handheld pulse oximeters (Model 8500 with no memory feature and the 8500M which has a memory feature). Some of the devices distributed may not have the correct pulse oximetry board with the integrated memory feature.

What to do

FDA enforcement status: Terminated

Brands named

nonin medicalnonin

Recall history

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

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