rainbow Reusable Sensors. RAINBOW DCI-DC3… recallZ-0338-2016 · Masimo Corporation · initiated Oct 28, 2015
Class II Terminated All recalls posted in November 2015
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Masimo Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was 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.
FDA root cause category: Finished device change control
What the company is doing
Masimo sent an Urgent Product Recall letter on October 28, 2015, to all affected customers to inform them that Masimo has identified specific lots of sensors that were manufactured with incompatiable configurations. The letter provides the customers with the problems identified and the actions to be taken. Customers are instructed to complete the tracking/verification form and email to Masimo. Customers with questions were instructed to contact Masimo Technical Services at http://Service.Masimo.com. For questions regarding this recall call 949-297-7000.
Recall details
- Recall number
- Z-0338-2016
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Oct 28, 2015
- Posted by the FDA
- Nov 25, 2015
- Recalling firm
- Masimo Corporation
- Quantity
- 3476 units total (3322 units in US)
- Product code
- DQA
- FDA submissions
- K080238
- Distribution
- Worldwide Distribution - US (nationwide) and Internationally to Australia, Costa Rica, France, Germany, Kuwait, Martinique, Netherlands, Norway, South Korea, and Turkey.
Product description
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.
Code information (models, lots, serial numbers)
2201 2407 2696 2697
Other devices under the same FDA submission
11 devices cleared under K080238 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Rad-57™ Pulse CO-Oximeter™ 9216Masimo Corporation · Oximeter70 reports
- LNCS-II rainbow 4067Masimo Corporation · Oximeter1 recall1 report
- LNCS-II rainbow 4068Masimo Corporation · Oximeter1 recall0 reports
- rainbow® DCI® SpCO® SpMet® SpO2 Adult Reusable Sensor 2696Masimo Corporation · Oximeter14 reports
- MasimoSET® rainbow RC-4 rainbow® Patient Cable 2406Masimo Corporation · Oximeter5 reports
- MasimoSET® rainbow RC-1 rainbow® Patient Cable 2405Masimo Corporation · Oximeter3 reports
- rainbow® DCI-dc3 SpCO® SpMet® SpO2 Adult Direct Connect Reusable Sensor 2201Masimo Corporation · Oximeter2 reports
- rainbow® DCI® SC 200 SpHb® SpO2 SpMet® 200 spot checks Adult Reusable Sensor 3418Masimo Corporation · Oximeter2 reports
- rainbow DCI-dc8 SpCO SpMet SpO2 Adult Direct Connector Reusable Sensor 2407Masimo Corporation · Oximeter1 report
- MasimoSET rainbow® RC25-4RA rainbow® Patient Cable 3375Masimo Corporation · Oximeter1 report
- DCIP SC 200 200 spot checks Pediatric/Slender digit Reusable Sensor 3419Masimo Corporation · Oximeter1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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