Class II — Covidien LLC
| Recalling firm | Covidien llc |
|---|---|
| Registered facility | View this company's 22 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Labeling error: The label indicates the product is latex free, but the headband component included with the forehead sensor does contain latex. |
| 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. |
| Quantity | 7453 Units |
| Distribution | Nationwide. Foreign: Belgium Germany France Netherlands |
| Initiated | 2016-12-16 |
| Classified | 2017-02-02 |
| Terminated | 2018-12-04 |
| Recall number | Z-1125-2017 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Covidien LLC (Z-1125-2017).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/76062/
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