Nonin Medical, Inc: Medical Device Recall in 2017 - (Recall #: Z-1690-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

8500M Handheld Pulse Oximeter

Product Classification:

Class II

Date Initiated: September 29, 2016

Date Posted: April 5, 2017

Recall Number: Z-1690-2017

Event ID: 75424

Reason for Recall:

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.

Status: Terminated

Product Quantity: 15 (11 US; 4 OUS)

Code Information:

502002091 502002088 502002087 502002083 502002085 502002086 502002081 502002082 502002080 502002079 502002077 502002078 502002089 502002090

Distribution Pattern:

Distribution in US (MI, NC, OH, NC, VA), and CANADA

Voluntary or Mandated:

Voluntary: Firm initiated