Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

8500M Handheld Pulse Oximeter Recalled by Nonin Medical, Inc Due to Nonin manufactures and sells two 8500 handheld pulse...

Date: September 29, 2016
Company: Nonin Medical, Inc
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Nonin Medical, Inc directly.

Affected Products

8500M Handheld Pulse Oximeter

Quantity: 15 (11 US; 4 OUS)

Why Was This Recalled?

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.

Where Was This Sold?

This product was distributed to 4 states: MI, NC, OH, VA

Affected (4 states)Not affected

About Nonin Medical, Inc

Nonin Medical, Inc has 2 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report