FDA Device recall Z-1125-2017
Covidien Nellcor SpO2 Forehead Sensor Item Code: RS10
- FDA Device
- Class II
- terminated
- Published 2017-02-08
On 2017-02-08 the FDA classified a Class II recall of Covidien Nellcor SpO2 Forehead Sensor Item Code: RS10 by Covidien, citing labeling error: The label indicates the product is latex free, but the headband component included with the forehead sensor does contain latex.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1125-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-12-16 |
| Published | 2017-02-08 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Covidien |
| Distribution | US |
Product
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.
Reason
Labeling error: The label indicates the product is latex free, but the headband component included with the forehead sensor does contain latex.
Identifiers
| code_info | Lot Numbers: 161510095H, 161620089H, 161690203H, 161760132H, 161900091H,161970090H, 162040107H, 162110103H, 162320191H, 162390212H |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1125-2017%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.