Class II — Potential Health Hazard

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

SenSmart Recalled by Nonin Medical, Inc Due to Nonin Medical is conducting a recall of certain...

Date: November 25, 2014
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

SenSmart, Regional Oximetry EQUANOX Classic Plus Adult/Pediatric Sensor > 40 kg., Model 8003CA (REF 9824-001, 3-Wavelength), 8004CA (REF 9705-001, 4-Wavelength), with associated materials (INT-100 cable, operator's manual; and Quick Start Guide). Sensors are single-packed in a pouch, then multi-packed, 20 per shelf-box.

Quantity: 5892 (5452 US, 440 OUS)

Why Was This Recalled?

Nonin Medical is conducting a recall of certain regional oximetry sensors and associated products. They have received reports of signal loss during use of our shortcabled regional oximetry sensors with diaphoretic patients. No injury or illness have been reported.

Where Was This Sold?

To be provided later.

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