CLASS II Device recall · Reported 2 Dec 2015 · FDA Enforcement Report

rainbow Reusable Sensors recalled by Masimo

Masimo is recalling rainbow Reusable Sensors, distributed nationwide in the US. The recall was initiated on 28 Oct 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes2201 2407 2696 2697

Quantity recalled3476 units total (3322 units in US)

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0338-2016
FDA event ID: 72626
Recalling firm: Masimo, Irvine, CA
Classification: Class II
Status: Terminated
Recall initiated: 28 Oct 2015
FDA classified: 25 Nov 2015
Reported: 2 Dec 2015
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Labeling Errors
Device type: Patient Monitors

Timeline

28 Oct 2015	Recall initiated by company
25 Nov 2015	Classified by FDA	+28 days
2 Dec 2015	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

These sensors were manufactured with incompatible configurations. This could result in sensors that will provide either no readings or inaccurate readings for the SpCO and SpMet parameters.

Product as listed by the FDA

rainbow Reusable Sensors. RAINBOW DCI-DC3, SpO2/SpCO/SpMet, Part No. 2201; RAINBOW DCI-dc8, SpO2/SpCO/SpMet, Part No. 2407; RAINBOW DCI, SpO2/SpCO/SpMet, Part No. 2696; RAINBOW DCIP, PED, SpO2/SpCO/SpMet, Part No. 2697. rainbow reusable sensors are indicated for spot check or continuous non-invasive monitoring of arterial saturation (SpO2), arterial carboxyhemoglobin saturation (SpCO), arterial methemoglobin (SpMet), and pulse rate.

Where it was distributed

Worldwide Distribution - US (nationwide) and Internationally to Australia, Costa Rica, France, Germany, Kuwait, Martinique, Netherlands, Norway, South Korea, and Turkey.

Nationwide

Questions about this recall

Why was it recalled?

These sensors were manufactured with incompatible configurations. This could result in sensors that will provide either no readings or inaccurate readings for the SpCO and SpMet parameters.

Which lots are affected?

2201 2407 2696 2697

Where was it sold?

Worldwide Distribution - US (nationwide) and Internationally to Australia, Costa Rica, France, Germany, Kuwait, Martinique, Netherlands, Norway, South Korea, and Turkey.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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