Covidien Nellcor SpO2 Forehead Sensor Item Code: RS10 — Class II medical device recall Z-1125-2017
Terminated recall by Covidien LLC, reported 2017-02-08, distributed nationwide. Labeling error: The label indicates the product is latex free, but the headband component included with the fo
| Recall number | Z-1125-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Covidien LLC, North Haven, CT, United States |
| Recall initiated | 2016-12-16 |
| Classified | 2017-02-02 |
| Reported by FDA | 2017-02-08 |
| Terminated | 2018-12-04 |
| Distributed | Nationwide (US) |
| Countries outside the US | BE, DE, FR, NL |
| Quantity | 7,453 units |
| Reason classes | labeling |
| Lot numbers | 161510095H, 161620089H, 161690203H, 161760132H, 161900091H, 161970090H, 162040107H, 162110103H, 162320191H, 162390212H |
| Model numbers | RS10 |
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 for recall
Labeling error: The label indicates the product is latex free, but the headband component included with the forehead sensor does contain latex.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1125-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.