CLASS II Device recall · Reported 8 Feb 2017 · FDA Enforcement Report
Nellcor SpO2 Forehead Sensor recalled by Covidien
Covidien is recalling Covidien Nellcor SpO2 Forehead Sensor, distributed nationwide in the US. The recall was initiated on 16 Dec 2016 and the FDA has classified it as Class II.
Check your package
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-1125-2017
- FDA event ID
- 76062
- Recalling firm
- Covidien, North Haven, CT
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 16 Dec 2016
- FDA classified
- 2 Feb 2017
- Reported
- 8 Feb 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Labeling Errors
- Device type
- Patient Monitors
Timeline
| 16 Dec 2016 | Recall initiated by company | |
| 2 Feb 2017 | Classified by FDA | +48 days |
| 8 Feb 2017 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Labeling error: The label indicates the product is latex free, but the headband component included with the forehead sensor does contain latex.
Product as listed by the FDA
Covidien Nellcor SpO2 Forehead Sensor Item Code: RS10; The Covidien Nellcor¿ Forehead SpO2Sensor, model RS10, is indicated for use when continuous non-invasive arterial oxygen saturation and pulse rate monitoring are required for patients weighing more than 40 kg.
Where it was distributed
Nationwide. Foreign: Belgium Germany France Netherlands
Questions about this recall
Is Nellcor SpO2 Forehead Sensor recalled?
Yes. Covidien recalled Nellcor SpO2 Forehead Sensor on 16 Dec 2016. The recall is Class II and its status is Terminated. Recall number Z-1125-2017.
Why was it recalled?
Labeling error: The label indicates the product is latex free, but the headband component included with the forehead sensor does contain latex.
Which lots are affected?
Lot Numbers: 161510095H, 161620089H, 161690203H, 161760132H, 161900091H,161970090H, 162040107H, 162110103H, 162320191H, 162390212H
Where was it sold?
Nationwide. Foreign: Belgium Germany France Netherlands
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 21 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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